Evaluation of Tangible Boost Replenishing System
Phase: NA
Conditions: Contact Lens Solution
Sponsor: Tangible Science

FULL PROTOCOL TITLE: An Evaluation of Tangible Boost Replenishing 
System on the Continued Efficacy of Tangible HydraPEG Rigid Gas Permeable 
Contact Lens Coating. 
Page 1 of 22
Revised: July 24, 2017
PRINCIPAL INVESTIGATOR: 
Maria K. Walker, OD, MS 
Optometry 
mkwalker@central.uh.edu 
Revised: 9/6/2017 
NCT03073148

FULL PROTOCOL TITLE: An Evaluation of Tangible Boost Replenishing 
System on the Continued Efficacy of Tangible HydraPEG Rigid Gas Permeable 
Contact Lens Coating. 
 
Page 2 of 22 
Revised: July 24, 2017 
Table of Contents 
1.0 
Objectives ............................................................................................................................ 3 
2.0 
Background .......................................................................................................................... 3 
3.0 
Inclusion and Exclusion Criteria .......................................................................................... 4 
4.0 
Vulnerable Populations ........................................................................................................ 6 
5.0 
Number of Subjects.............................................................................................................. 6 
6.0 
Recruitment Methods ........................................................................................................... 7 
7.0 
Multi-Site Research Communication ................................................................................... 8 
8.0 
Study Timelines ................................................................................................................... 8 
9.0 
Study Endpoints ................................................................................................................... 8 
10.0 Procedures Involved............................................................................................................. 9 
11.0 Setting ................................................................................................................................ 14 
12.0 Drugs or Devices................................................................................................................ 15 
13.0 Risks to Subjects ................................................................................................................ 15 
14.0 Potential Benefits to Subjects ............................................................................................ 16 
15.0 Provisions to Monitor Data to Ensure the Safety of Subjects ............................................ 16 
16.0 Withdrawal of Subjects ...................................................................................................... 16 
17.0 Costs/Payments to Subjects ............................................................................................... 17 
18.0 Compensation for Research-Related Injury ....................................................................... 17 
19.0 Confidentiality ................................................................................................................... 17 
20.0 Provisions to Protect the Privacy Interests of Subjects ...................................................... 19 
21.0 Informed Consent Process ................................................................................................. 20 
22.0 Process to Document Consent in Writing .......................................................................... 20 
23.0 HIPAA ............................................................................................................................... 20 
24.0 FERPA ............................................................................................................................... 20 
25.0 Data Management .............................................................................................................. 20 
26.0 Specimen Use and Banking ............................................................................................... 21 
27.0 Community-Based Participatory Research ........................................................................ 21 
28.0 Sharing of Results with Subjects ....................................................................................... 21 
29.0 Resources ........................................................................................................................... 21 
30.0 Additional Approvals ......................................................................................................... 22 
 
 
 

FULL PROTOCOL TITLE: An Evaluation of Tangible Boost Replenishing 
System on the Continued Efficacy of Tangible HydraPEG Rigid Gas Permeable 
Contact Lens Coating. 
 
Page 3 of 22 
Revised: July 24, 2017 
1.0 
Objectives 
1.1 Describe the purpose, specific aims, and/or objectives. 
The goal of this research is to determine if the Tangible Boost system adequately 
replenishes the HydraPEG coating on the surface of a rigid contact lens. 
HydraPEG is a soft and rigid contact lens coating, primarily composed of 
polyethylene glycol, which is covalently bound to the surface of a contact lens. The 
HydraPEG coating is intended to improve wettability and comfort with rigid 
lenses, and is currently FDA approved. HydraPEG can be applied to soft or rigid 
contact lenses, but the coating naturally diminishes from the surface of the lens 
over time (due to cleaning, and blinking over the surface of the contact lens). 
Tangible Science, the company that produces HydraPEG, has recently come out 
with a new product called Tangible Boost, intended to be used every 30 days and 
replenish the coating on the surface of the lens.  
 
Tangible Boost (also known as HydraPEG Replenish in some of the FDA 
documents) is a solution composed on the same components of the HydraPEG 
coating). Essentially, Tangible Boost solution is the HydraPEG coating, it is just in 
solution that can be used at home by the subjects after the initial HydraPEG is 
applied at the lens manufacturing lab. The Tangible Boost kit consists of two unit 
dose HydraPEG solutions (components A and B), as well as a barrel case, and the 
lens wearers are instructed to empty the two vials into the case and soak their 
lenses for 30 minutes every 30 days to replenish the coating. This product 
configuration has been optimized to facilitate ease of use for the patient. 
 
This is a study to evaluate the efficacy of Tangible boost to replenish the 
HydraPEG coating on rigid gas permeable (scleral and corneal) contact lenses. 
 
1.2 State the hypotheses to be tested. 
 
We hypothesize that the Tangible Boost replenishing system will re-build the 
HydraPEG coating that naturally diminished from the contact lens surface over 
time, and improve the comfort and visual performance of HydraPEG coated rigid 
gas permeable lenses. We anticipate that this be shown by improved patient 
symptoms and lens wettability after treatment with Tangible Boost. 
 
2.0 
Background 
2.1 Describe the relevant prior experience and gaps in current knowledge. 

FULL PROTOCOL TITLE: An Evaluation of Tangible Boost Replenishing 
System on the Continued Efficacy of Tangible HydraPEG Rigid Gas Permeable 
Contact Lens Coating. 
 
Page 4 of 22 
Revised: July 24, 2017 
Gas permeable rigid contact lenses are commonly used as refractive treatment, for 
normal individuals, but also specifically for individuals with irregular ocular 
surfaces that require the rigid lens material to mask irregularities on the front 
refracting surface of their eye (the cornea). However, these lenses rely on surface 
treatments and coatings in order to improve their interactions with the front surface 
of the eye and the tear film, which are very sensitive tissues that can respond 
negatively to the rigid materials (for example: discomfort, dryness). Several studies 
have found that reducing the friction between the lens and the surface of the eye 
(as well as the eyelid) will improve the comfort of the lens while a patient is 
wearing them. The primary principle behind HydraPEG coating and Tangible 
Boost replenishing system is that they reduce friction between the lens and the eye 
surface and eyelids.  
Contact lens manufacturers and distributors are continuously developing new 
products and technology to make the surface of a contact lens more compatible 
with the ocular surface. HydraPEG is a newly FDA approved coating that is 
available in the US and Europe, and the Tangible Boost treatment being evaluated 
here is an important component of maintaining this treatment of the lens surface.  
2.2 Describe any relevant preliminary data. Reference previously approved IRB 
protocols (by number), if applicable. 
Hydra-PEG (Ocular Dynamics, Menlo Park, CA) is a contact lens coating designed 
to improve the lens/ocular surface interface by mimicking the natural tear film’s 
water content and wettability. A previous study done at UH showed that the 
coating improved comfort and vision when applied to scleral contact lenses. (ID# 
16071-01). The Hydra-PEG coating is FDA approved for use as a contact lens 
coating.    
2.3 Provide the scientific or scholarly background for, rationale for, and 
significance of the research based on the existing literature and how will it 
add to existing knowledge. 
Knowledge gained by this work will increase our understanding of the surface 
characteristics of rigid lenses and the interaction of the lens surface with the ocular 
surface.  
 
3.0 
Inclusion and Exclusion Criteria 
3.1 Describe the specific criteria that define who will be included or excluded in 
your final study sample. Make sure to include age. 

FULL PROTOCOL TITLE: An Evaluation of Tangible Boost Replenishing 
System on the Continued Efficacy of Tangible HydraPEG Rigid Gas Permeable 
Contact Lens Coating. 
 
Page 5 of 22 
Revised: July 24, 2017 
The participant will be eligible to participate if the following criteria apply: 1. Written 
Informed Consent has been obtained prior to any study-related procedures taking place; 
2. Written documentation has been obtained in accordance with the relevant county and 
local privacy requirements, where applicable (i.e., Written Authorization for Use and 
Release of Health and Research Study Information to obtain contact lens prescription and 
wearing information from their medical record should the subject be a patient at the UH 
College of Optometry); 3. Male or female,18 years of age and older prior to the initial 
visit; 4. Is an established scleral or corneal rigid contact lens wearer; 5. In the opinion of the 
investigator, the subject has the ability to follow study instructions; 6. In the opinion of the 
investigator, the subject has the ability to complete all study procedures and visits.  
The participant would not be eligible to participate if at least one of the following criteria is 
met: 1. Has never worn either scleral or corneal contact lenses before; 2. Does not 
possess a usable pair of spectacles; 3. Has any ocular disease or abnormality that would 
affect the wearing of contact lenses; 4. Is aphakic (i.e., missing their natural lens inside the 
eye); 5. Is currently participating in any other type of eye-related clinical or research 
study; 6. Is pregnant or nursing as reported by the subject. 7. Has a condition or is in a 
situation which, in the investigator’s opinion, may put the subject at significant risk, may 
confound study outcomes, or may significantly interfere with the subject’s participation in 
the study. 8. Has a known and self-reported allergy to the following substances: Dextran, 
polyethylene glycol, hydroxypropyl methylcellulose, or polyvinyl alcohol, which 
are components of the Tangible Boost and HydraPEG systems. 9. Has had 
previous ocular surgery within the past 12 weeks.  
 
3.2 Describe how potential subjects will be screened for eligibility based on 
these criteria. 
Subjects will be screened as either corneal or scleral CL wearers prior to coming in 
for visit 1 of the study, either in person, over email, or over the phone when they 
show interest in the study. The screening for ability to wear a rigid lens in the study 
will occur at visit 1 by the investigator, when the subjects are diagnostically fit 
with a scleral or corneal lens (whichever modality they habitually wear).  
 
3.3 Indicate specifically whether you will include or exclude each of the 
following special populations: (You may not include members of the 
populations listed below as subjects in your research unless you indicate 
this in your inclusion criteria.) 
The following special populations will be excluded from this study: 

FULL PROTOCOL TITLE: An Evaluation of Tangible Boost Replenishing 
System on the Continued Efficacy of Tangible HydraPEG Rigid Gas Permeable 
Contact Lens Coating. 
 
Page 6 of 22 
Revised: July 24, 2017 
• 
Adults unable to consent  
• 
Individuals who are not yet adults (infants, children, 
teenagers) -  
• 
Pregnant women  
• 
Prisoners 
 
4.0 
Vulnerable Populations 
4.1 If the research involves individuals who are vulnerable to coercion or undue 
influence, describe additional safeguards included to protect their rights 
and welfare. 
Students may be recruited for participation in this study (if they wear rigid corneal 
or scleral lenses habitually), and the investigators on this study are instructors in 
the clinic at UHCO. These investigators will not be the individuals recruiting or 
obtaining consent from students in their own clinical student group at the time of 
the study. There will be no influence on grading of any student based on their 
participation or non-participation in this study.  
 
5.0 
Number of Subjects 
 
LOCAL: 
5.1 Indicate the total number of subjects to be accrued locally. 
A maximum of 40 subjects will be enrolled in this pilot study.  
 
5.2 If applicable, distinguish between the number of subjects who are expected 
to be enrolled and screened, and the number of subjects needed to complete 
the research procedures (i.e., numbers of subjects excluding screen 
failures.) 
We expect about a 20% screen fail/drop out rate, so will expect to recruit 
approximately 35-40 subjects, and the first 30 to be eligible and complete the study 
will be used for data analysis. 
 
5.3 If not provided in the “study-wide” section, provide justification for the 
number of subjects. A power analysis is required for research that is more 
than minimal risk. 

FULL PROTOCOL TITLE: An Evaluation of Tangible Boost Replenishing 
System on the Continued Efficacy of Tangible HydraPEG Rigid Gas Permeable 
Contact Lens Coating. 
 
Page 7 of 22 
Revised: July 24, 2017 
This is a low risk study; there are limited data collected in other studies on rigid 
lens wear with the HydraPEG coating, so the data collected in this preliminary 
study will be used for future power calculations for larger studies. We chose 30 
subjects to allow for an increased likelihood of reaching significance values with a 
moderate sample size. Further studies with larger sample sizes will likely be 
indicated if variability is high among the outcomes. 
 
6.0 
Recruitment Methods 
 
LOCAL: 
6.1 Describe when, where, and how potential subjects will be recruited. 
Recruitment will begin once IRB approval has been received, and will occur 
through The Ocular Surface Institute at UHCO. Subjects will be recruited through 
the methods described in 6.3, and if a patient is interested in participating in the 
study, they will be directed to the principal investigator or the study coordinator 
who will go over the study and ask the screening questions on the eligibility 
screening document (see appendix). If they are eligible based on the screening 
criteria, they will be invited for Visit 1 of the study. If the person calls to learn 
about the study the investigator or coordinator will use the outline to determine 
initial eligibility.  
 
6.2 Describe the source of subjects. 
Our study will involve established rigid contact lens wearers (corneal or scleral). 
The subject pool will consist of patients who are actively coming through the CL 
clinic, or individuals who are affiliated with UHCO and/or the UH community (ie. 
Faculty, students). All established corneal and scleral lens wearers in the 
community will be given the opportunity to participate in this study. We anticipate 
that most of our subjects will be from the patient population in the specialty 
contact lens service at the University Eye Institute at UHCO, which has a high 
population of rigid lens wearing patients actively coming through the clinic. We 
will not be doing a chart review and calling patients who are not coming into the 
clinic. Patients that do not come into the clinic but hear about it by word-of-mouth 
or through a UHCO affiliate are welcomed to participate.  
 
6.3 Describe the methods that will be used to identify potential subjects. 

FULL PROTOCOL TITLE: An Evaluation of Tangible Boost Replenishing 
System on the Continued Efficacy of Tangible HydraPEG Rigid Gas Permeable 
Contact Lens Coating. 
 
Page 8 of 22 
Revised: July 24, 2017 
A recruitment ad will be printed (see appendix) and will be placed on bulletin 
boards around the UHCO campus (there are specific boards designated for study 
announcements on the campus), and at the check-in counter at the cornea and 
contact lens service at the University Eye Institute. In addition, the study 
coordinator will email a copy of the recruitment ad to the faculty and staff at 
UHCO (not the entire university). Clinicians working at the UEI may speak to 
patients and/or give them a copy of the recruitment advertisement to review. 
 
6.4 Describe materials that will be used to recruit subjects.  
See appendix for recruitment advertisements to be posted and emailed, and a phone 
and in-person eligibility screening outline. 
 
7.0 
Multi-Site Research Communication – N/A  
 
8.0 
Study Timelines 
8.1 Describe: 
The total duration of the subjects’ participation in the study will be approximately 
5 months. It is anticipated that to enroll all study subjects it will take approximately 
4-6 months. The estimated date for completion of this study is 11-12 months after 
the start of recruitment.  
Visit 1: The total time commitment required is approximately 100 minutes once 
informed consent has been commenced until the last test is completed.  
Visit 2: The total time commitment required is approximately 45 minutes until the 
last test is completed. 
Visit 3: The total time commitment required is approximately 85 minutes until the 
last test is completed. 
Visit 4: The total time commitment required is approximately 25 minutes until the 
last test is completed. 
Visit 5: The total time commitment required is approximately 25 minutes until the 
last test is completed. 
 
9.0 
Study Endpoints 
9.1 
The primary endpoints in this study are as follows: 
• visual acuity 
• contact lens comfort questionnaire 
• keratograph surface evaluation (tear break up score) 
• ocular surface staining 

FULL PROTOCOL TITLE: An Evaluation of Tangible Boost Replenishing 
System on the Continued Efficacy of Tangible HydraPEG Rigid Gas Permeable 
Contact Lens Coating. 
 
Page 9 of 22 
Revised: July 24, 2017 
9.2 
The secondary endpoints in this study are as follow: 
• contact lens fitting characteristics (apical clearance, 
limbal clearance, scleral landing evaluation) 
 
10.0 Procedures Involved 
10.1 Describe and explain the study design. 
Once a subject has been identified, the initial visit will be scheduled. During the 
experimental day, informed consent will be completed, and the subjects will 
complete the following tasks: (1) an investigator will conduct visual acuity 
assessments of both eyes (Snellen). (2) The subjects will be asked to complete a 
survey (on contact lens satisfaction). (3) After the survey, the subject will sit with 
their lenses for assessment using the Keratograph topographer. (4) After 
topography, slit lamp assessment of the rigid lenses, and then of the cornea and 
conjunctiva (after lens removal) with and without Lissamine Green staining will be 
done.  
At visit one, the following additional task will be performed: (1) The subject will 
be asked to sit for a corneal or scleral lens fitting visit (based on what they wear 
habitually), where the investigator will fit the subject with a commercially 
available scleral or corneal lens.  All subjects will be refit into the Advanced 
Vision Technologies (AVT) brand of rigid lenses, manufactured at AVT 
Technologies in Colorado. If they already wear the AVT brand, the lens 
parameters will simply be re-ordered. All lenses will undergo a diagnostic fit with 
an AVT lens.  The parameters available at AVT are similar to those available at all 
other major labs in the US.  
 
A second visit will be to evaluate the fit of the ordered study lenses (which will 
have been coated with the HydraPEG coating), and will be for the dispense of the 
lenses. In addition to evaluating the lenses, the subjects will be asked to complete a 
short survey on their satisfaction with their current lenses. After this visit, the 
subjects will then wear the lenses for 30 days, on a daily basis as they habitually 
would, cleaning the lenses with ClearCare hydrogen peroxide cleaning system, a 
commonly used commercially available soft and rigid contact lens cleaner. After 
30 days of lens wear, they will report for visit 3.   
 
At the third visit, the same testing will be performed from visits 1 and 2, the 
subject will also be given an additional survey regarding the satisfaction with the 
HydraPEG lenses, and then the Tangible Boost kit or the placebo kit (consisting of 

FULL PROTOCOL TITLE: An Evaluation of Tangible Boost Replenishing 
System on the Continued Efficacy of Tangible HydraPEG Rigid Gas Permeable 
Contact Lens Coating. 
 
Page 10 of 22 
Revised: July 24, 2017 
two vials with Unique pH) solutions will be dispensed (randomized) to store their 
lenses in for 30 minutes that night.  
 
The solution will be dispensed and the subjects trained on its use, and the subjects 
will be asked to store their lenses in the given solution for 30 minutes that evening, 
and then transfer their lenses to Unique pH multipurpose rigid lens solution for 
overnight storage. For the initial training with the Boost or placebo system, the 
users will undergo an approximately 60-minute user training in which there will be 
visual and audio recording and still photographs taken in order for a human factors 
company (Userwise) to analyze the usability of the product. The investigator at the 
study visit will act as the monitor for the training session. This recorded training 
step was specifically designed to allow for proper evaluation of the usability of the 
product, which they will report to the FDA to ensure usability. At the initial visit, 
the subject will have indicated on the informed consent form whether they agree to 
participate in the recorded portion of the training.  If they do not participate in the 
recording, they can still be trained and participate in the study. 
 
The subjects will report to the Ocular Surface Institute the next day for Visit 4, at 
which time the comfort and visit tests will occur again, and an additional survey to 
evaluate the boost treatment will be given. After visit 4, the subjects will continue 
to wear the study lenses daily for an additional 60 days, treating their lenses again 
in the Boost or placebo solution at the midpoint between visit 4 and 5 (30 days 
after the first treatment with Boost), otherwise cleaning nightly with ClearCare, 
and will then report to the clinic again 30 days after the midway treatment 
(approximately 90 days after the initial HydraPEG dispense). The same visit 
testing will be done at this final and 5th visit, and a final short survey will be done, 
and then the lenses will be collected from the subjects and sent back to Tangible 
Science, Inc. for their internal testing of the lenses (no involvement of the UH 
research team). At this time the study will conclude.  
 
The following table outlines each of the study visits and tells what procedures will 
be done at each visit: 
 
Procedure 
Length of Time 
Required for 
Frequency of Repetition 
VISIT 1: Initial Evaluation 
Informed consent & HIPAA 
35 minutes 
Once 
General History and medications  
5 minutes 
Once per visit 
Visual Acuity 
5 minutes 
Once per visit 

FULL PROTOCOL TITLE: An Evaluation of Tangible Boost Replenishing 
System on the Continued Efficacy of Tangible HydraPEG Rigid Gas Permeable 
Contact Lens Coating. 
 
Page 11 of 22 
Revised: July 24, 2017 
Questionnaires (CLDEQ8 + VAS) 
10 minutes 
Once per visit 
Keratograph Surface Evaluation 
5 minutes 
Once per visit 
Slit-lamp Examination (with lenses 
on and after lens removal) 
10 minutes 
Once per visit 
Scleral lens / corneal lens fitting 
30 minutes 
Once  
TOTAL TIME 100 minutes 
 
 
 
 
VISIT 2: HydraPEG dispense 
Visual Acuity 
5 minutes 
Once per visit 
Questionnaires (CLDEQ8 + VAS 
+ Secondary VAS for V2) 
10 minutes 
Once per visit 
Keratograph Surface Evaluation 
5 minutes 
Once per visit 
Slit-lamp Examination 
5 minutes 
Once per visit 
Scleral/corneal lens evaluation & 
dispense. (handling & care 
paperwork will be dispensed at this 
visit) 
20 minutes 
Once  
TOTAL TIME 45 minutes 
 
*additional visits may be required to achieve an adequate contact lens fit if the lenses are 
not acceptable. It is anticipated that the fitting process will take 1-3 visits total (including 
Visit 1 and 2).  The only tasks done at any additional fitting visits will be to evaluate the fit 
of the lens and make any necessary changes. Follow-up fitting visits are expected to take 15 
minutes – for a slit lamp evaluation of the lenses and necessary parameter changes to be 
determined. Since these are established wearers, we do not anticipate a long fitting process. 
 
 
 
VISIT 3: Tangible Boost Dispense 
Visual Acuity 
5 minutes 
Once per visit 
Questionnaires (CLDEQ8 + VAS 
+ Secondary VAS for V3) 
10 minutes 
Once per visit 
Keratograph Surface Evaluation 
5 minutes 
Once per visit 
Slit-lamp Examination 
5 minutes 
Once per visit 
Tangible Boost kit dispense & 
training 
60 minutes 
Once  
TOTAL TIME 85 minutes 
 
 
 
 
VISIT 4: Tangible Boost Follow-Up #1 
Visual Acuity 
5 minutes 
Once per visit 
Questionnaires (CLDEQ8 + VAS 
+ Secondary VAS for V4) 
10 minutes 
Once per visit 
Keratograph Surface Evaluation 
5 minutes 
Once per visit 
Slit-lamp Examination 
5 minutes 
Once per visit 

FULL PROTOCOL TITLE: An Evaluation of Tangible Boost Replenishing 
System on the Continued Efficacy of Tangible HydraPEG Rigid Gas Permeable 
Contact Lens Coating. 
 
Page 12 of 22 
Revised: July 24, 2017 
TOTAL TIME 25 minutes 
 
 
 
 
VISIT 5 
 
 
Visual Acuity 
5 minutes 
Once per visit 
Questionnaires (CLDEQ8 + VAS 
+ Secondary VAS for V5) 
10 minutes 
Once per visit 
Keratograph Surface Evaluation 
5 minutes 
Once per visit 
Slit-lamp Examination 
5 minutes 
Once per visit 
TOTAL TIME 25 minutes 
 
 
 
10.2 Provide a description of all research procedures being performed and when 
they are performed. 
 
 
The testing descriptions are summarized in the table below: 
 
Test 
Description 
Video/Audio 
recording 
General History 
and Medications 
Participants will be asked questions about their general, 
ocular and medication use histories along with contact 
lens use history if applicable.  
No 
Questionnaires 
Subjects will be asked to fill out the following 
questionnaires: 
• Contact Lens Dry Eye Questionnaire - 8 
(CLDEQ – 8) 
• Visual analog scale (VAS) 0-100 
• Secondary VAS scales at Visits 2-5 (unique to 
each visit) 
These questionnaires assess the level of eye and/or 
contact lens discomfort, and assess the subject 
perception of their habitual lenses and the coated lenses 
before and after Boost treatment.  
No 

FULL PROTOCOL TITLE: An Evaluation of Tangible Boost Replenishing 
System on the Continued Efficacy of Tangible HydraPEG Rigid Gas Permeable 
Contact Lens Coating. 
 
Page 13 of 22 
Revised: July 24, 2017 
Scleral/Corneal 
lens fitting 
The examiner will fit the subjects with scleral or corneal 
contact lenses using commercially available lens fitting 
sets 
(AVT 
scleral 
and 
corneal 
designs, 
AVT 
Technologies, CO). The lenses will be fit using the 
customary fitting procedure, where a diagnostic lens is 
applied to the eye, an over-refraction is performed, and 
then customized lenses are ordered with the over-
refraction incorporated and any fitting parameters are 
altered based on the investigators’ expertise. Once the 
lenses are dispensed, the subjects will be reminded of 
proper handling and cleaning techniques, and given a 
handout on lens care. In addition, at the 30-day visit 
subjects will be given instructions on the tangible boost 
kit or placebo that they are supplied. 
No 
Scleral/Corneal 
Lens Evaluation 
The ordered rigid lenses will be applied to the eye of the 
subject by the investigator, after which the fit and vision 
will be evaluated. At this time, if the fit of the lens is 
adequate, the lenses will be dispensed. If there are 
additional parameter changes needed, they will be 
ordered at this time.  
No 
Visual Acuity 
The participant’s vision in each eye will be measured 
with a high contrast visual acuity chart for the subjects’ 
habitual lenses and the test lenses. The participant will 
be asked to cover one eye and read the chart, and this 
procedure will be repeated for the other eye.   
No 
Slit-lamp 
Examination 
The participant’s front portion of each eye and contact 
lenses will be examined with a lighted microscope. The 
participant will be asked to place his/her chin on the 
chinrest and place his/her forehead against the bar and 
look straight ahead. The instruments light will be shined 
onto the eye to visualize the ocular surface for 
approximately 2-3 minutes per eye.   
No 
Oculus 
Keratograph  
The OCULUS Keratograph® 5M is an advanced corneal 
topographer with a built-in real keratometer and a color 
camera optimized for external imaging. It also has a 
module called the Non-invasive keratograph break-up 
time, which allows us to evaluate the wettability of the 
front surface of the lens. The new infrared illumination 
is not visible to the human eye. This prevents glare 
during the examination. 
No 
Lissamine 
GreenGlo Strips 
Individual paper strips, impregnated with 1.5mg of Lissamine 
Green dye. The dye is attracted to dead cells and 
irregularities at the ocular surface. These strips are commonly 
No 

FULL PROTOCOL TITLE: An Evaluation of Tangible Boost Replenishing 
System on the Continued Efficacy of Tangible HydraPEG Rigid Gas Permeable 
Contact Lens Coating. 
 
Page 14 of 22 
Revised: July 24, 2017 
used in practice as the gold standard for evaluating 
compromise to superficial corneal or conjunctival tissue. (for 
this study we will be not be using sodium fluoroecein, which 
is also sometimes used to assess the tear film). 
Product usability 
training 
Because this is a new product, the company is interested in 
evaluating the usability of the product based on the 
instructions in the kits. The subjects will be asked to read the 
instructions and use the boost product on a pair of dummy 
lenses without any interference from the investigator. The 
investigator will act as the monitor, and they will follow the 
prompts on the instruction sheet (in the appendix) to lead the 
subjects through the training. The subjects will be recorded, 
and still photos may be taken. There are prompted questions 
that the investigator will ask the subjects about their use of the 
product (see the questions and prompts in the appendix 
document called Tangible Boost Datasheet). Subjects will be 
recognizable through the video and audio footage, because the 
company needs to evaluate facial expressions to observe 
usability characteristics. This will allow a human factors team 
at the company to assess how usable the product is based on 
the packaging and current instructions. See appendix for the 
Boost kit instructions, as well as the Userwise instruction and 
prompt sheet.  
Yes 
 
Statisical Analysis: Each individual will act as their own control to measure differences in pre 
and post contact lens measurements (paired non-parametric statistics), and this baseline data will 
be compared to normative data available for a soft contact lens wearing population. Descriptive 
statistics will also be employed to evaluate the overall response of the eye to a rigid lens with and 
without HydraPEG and with and without Tangible Boost.  
10.3 
What data will be collected, including long-term follow-up? 
The following data will be collected in this study: 
• visual acuity 
• contact lens comfort questionnaire 
• keratograph surface evaluation (tear break up score) 
• ocular surface staining 
• contact lens fitting characteristics (apical clearance, 
limbal clearance, scleral landing evaluation) 
 
11.0 Setting 
11.1 Describe the sites or locations where your research team will conduct the 
research. 

FULL PROTOCOL TITLE: An Evaluation of Tangible Boost Replenishing 
System on the Continued Efficacy of Tangible HydraPEG Rigid Gas Permeable 
Contact Lens Coating. 
 
Page 15 of 22 
Revised: July 24, 2017 
Subjects will be asked to complete measurements at the study visits, which will be 
conducted in clinical research facilities associated with the University of Houston College 
Of Optometry. The study visits will take place in The Ocular Surface Institute’s research 
exam rooms in the Health and Biomedical Sciences Building (HBSB). 
 
12.0 Drugs or Devices 
 
Corneal and Scleral lenses are considered class II medical devices by the FDA. All rigid lens 
materials are FDA approved for use in a rigid contact lens, they are not investigative 
devices. All lenses will be stored in room 236 of the HBSB at UHCO until time of dispense 
to the subjects, and only study investigators will have access to the lenses.   
 
The Tangible Boost Replenishing system is not yet FDA approved but is undergoing approval, 
and the ingredients are all classified under the GRAS (generally recognized as safe) designation 
through the FDA. The boost system contains the same ingredients as the Hydra-PEG coating that 
it is designed to replenish. The HydraPEG coating has received approval for use with rigid 
contact lenses. Full product information regarding the Tangible Boost system, as well as 
correspondence with the FDA is in the appendix.  
 
13.0 Risks to Subjects 
13.1 List the reasonably foreseeable risks, discomforts, hazards, or 
inconveniences to the subjects related the subjects’ participation in the 
research. Include as may be useful for the IRB’s consideration, describe the 
probability, magnitude, duration, and reversibility of the risks. Consider 
physical, psychological, social, legal, and economic risks. 
Contact lens subject risks are those that are already associated with wearing a 
contact lens. These risks include developing an abrasion (‘cut’ on the eye) during 
lens application or removal, excessive debris accumulation on or beneath the 
lenses, ocular stinging, redness, itching, or irritation. All contact lens wearers are at 
risk for developing inflammatory and/or infectious complications during lens wear, 
but there is no added risk by participating in this study. There are no unforeseeable 
risks that the investigators can imagine with any of the procedures in this study.  
 
13.2 Describe procedures being performed to monitor subjects for safety 
If a subject experiences an adverse event during the duration of the study, they will 
be instructed to call the study coordinator who will communicate with the 
investigators to determine the best course of action. If the subject needs to be seen 
due to an adverse event, a study investigator will examine them and the customary 
procedure for management will be followed.  

FULL PROTOCOL TITLE: An Evaluation of Tangible Boost Replenishing 
System on the Continued Efficacy of Tangible HydraPEG Rigid Gas Permeable 
Contact Lens Coating. 
 
Page 16 of 22 
Revised: July 24, 2017 
 
13.3 Describe procedures performed to lessen the probability or magnitude of 
risks. 
The investigators will be instructing subjects on the proper handling and care of 
their lenses, and will instruct the subjects of symptoms of an adverse event and 
who to call in that case (the coordinator). If an adverse event such as an abrasion 
occurs during a study visit, the condition will be treated as it is customarily, and 
the fees associated with treatment will be covered by the study.  
 
14.0 Potential Benefits to Subjects 
14.1 Describe the potential benefits that individual subjects may experience from 
taking part in the research. Include as may be useful for the IRB’s 
consideration, the probability, magnitude, and duration of the potential 
benefits. 
There is no direct benefit to the subject in participating in this study. 
 
15.0 Provisions to Monitor Data to Ensure the Safety of Subjects – N/A 
 
16.0 Withdrawal of Subjects 
16.1 If applicable, describe anticipated circumstances under which subjects will 
be withdrawn from the research without their consent. 
Subjects will be withdrawn from the study if they are unable to complete the tasks 
in the study protocol. In addition, if they experience an adverse event in which the 
investigator does not feel that the subjects should continue wearing the scleral 
lenses, they will be withdrawn.  
 
16.2 Describe any procedures for orderly termination. 
If a subject is terminated from the study prior to completion, they will still be 
compensated with the gift cards at the end of each study visit that they attend. They 
will not be compensated with gift cards for study visits that they do not attend.  
 
16.3 Describe procedures that will be followed when subjects withdraw from the 
research, including partial withdrawal from procedures with continued data 
collection. 

FULL PROTOCOL TITLE: An Evaluation of Tangible Boost Replenishing 
System on the Continued Efficacy of Tangible HydraPEG Rigid Gas Permeable 
Contact Lens Coating. 
 
Page 17 of 22 
Revised: July 24, 2017 
The data from a subject that withdraws or is terminated from the study will not be 
included in the analysis.  
 
17.0 Costs/Payments to Subjects 
17.1 Describe any costs that subjects may be responsible for due to their 
participation in the described research. 
The only cost that the subjects may be responsible for in this study is the cost of 
transportation to and from the UEI.  
 
17.2 Describe the amount and timing of any payments or inducements to 
subjects. 
Participants will receive a $20 Amazon.com gift card as compensation for their time at 
each scheduled visit that is completed (ie. Not paid for unscheduled visits needed to achieve 
fit if indicated), for a total compensation of $100 if all five study visits are completed. If 
the subject comes in for a study visit but is ultimately unable to complete the visit after it 
has begun, they will still be compensated with a $20 gift card. There will be no additional 
gift cards or compensation given to subjects for coming in for the potential additional fitting 
visits that may be required if there is a need for additional modifications of the lens to 
achieve adequate fit and vision.  
18.0 Compensation for Research-Related Injury  
 
If there is an ocular injury in this study directly related to the use of the contact lenses and the 
cleaning systems, treatment for the injury and any subsequent referrals will be covered by the 
study. The subject will not receive any direct compensation. If there is an unrelated or non-ocular 
injury during a subject’s enrollment in the study, it will not be covered by the study.  
 
19.0 Confidentiality 
19.1 Describe the local procedures for maintenance of confidentiality. 
The subject ID worksheet, informed consent, subject surveys, and examiner 
worksheets will all be kept in a single binder, locked in the data collection office at 
The Ocular Surface Institute. The informed consent forms and the subject ID 
worksheet will be kept in a separate binder from the study data.  The video and 
audio information, as well as the questions asked regarding the use of the Tangible 
Boost system, will be sent to UserWise for analysis. Video and audio data will be 
uploaded to a secure drop box which has limited access to appointed personnel at 
Tangible Science and UserWise.  This video and audio data will then be 

FULL PROTOCOL TITLE: An Evaluation of Tangible Boost Replenishing 
System on the Continued Efficacy of Tangible HydraPEG Rigid Gas Permeable 
Contact Lens Coating. 
 
Page 18 of 22 
Revised: July 24, 2017 
transferred to either a portable hard drive at UserWise or a limited access server 
that is accessible only to  employees who need it for writing the report.  Once the 
report is written, this hard drive is stored in a locked archive that has limited 
employee access and electronic records are stored in a limited access server. 
At UserWise, employees only have access to copies of the subject data on a need 
to know basis while writing up the report.  Datasheets do not have any participant 
names on them, only participant numbers.  Only participant numbers are used for 
writing the report and describing use errors.  Once the report is written, electronic 
files are stored in a limited access server and any hard drives with video data are 
stored in a locked archive that has limited employee access. 
19.2 Describe what direct identifiers will be obtained and any coding systems 
that will be used for study data (and specimens, if applicable). Note that: 
At the start of participation in the study, the subject will be assigned a non-
identifiable subject ID that will be used for identification on all other documents 
used in the study. This identification document, which will be the only document 
that decodes the subject, will be kept in a locked filing bin in a locked room within 
The Ocular Surface Institute, separate from the informed consent and other study 
documents. Names, email addresses, and telephone numbers will be recorded in 
this subject ID worksheet, which will be a paper file kept in the locked office of the 
principal investigator (Dr. Maria Walker, office 236 in HSB1).  
 
All other exam findings (survey, questionnaire, exam findings) will be recorded on 
the paper forms and stored in a binder. This binder will be kept locked in the 
principal investigator's office (Room 236) when not being used to add or remove 
data collection worksheets. 
19.3 Will anyone outside the research team have access to the identifiers? 
Only the investigators and necessary UserWise employees will have access to the 
paper and electronic records kept in this study. UserWise employees will only be 
given the data needed to perform the usability study (audio, video, questions) 
 
19.4 How long will the key to the study code be maintained? If not destroyed 
following data collection, provide justification for maintaining.  
All study data will remain on UH property within The Ocular Surface Institute for a minimum of 3 years 
following study completion. The link will be maintained to allow pertinent regulatory or government 
agencies to inspect the data and ensure that subjects participated in the study. In addition, Userwise 
may keep the recording indefinitely and may use the data for other medical research involving 
the product or subsequent products by the study sponsor. 

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System on the Continued Efficacy of Tangible HydraPEG Rigid Gas Permeable 
Contact Lens Coating. 
 
Page 19 of 22 
Revised: July 24, 2017 
The principal investigator will be responsible for maintaining study data security and 
subject confidentiality. 
 
19.5 If audiotaping is conducted, will the recordings be destroyed upon 
transcription? If not, provide justification.  
N/A 
 
20.0 Provisions to Protect the Privacy Interests of Subjects 
20.1 Describe the steps that will be taken to protect subjects’ privacy interests. 
“Privacy interest” refers to a person’s desire to place limits on whom they 
interact or whom they provide personal information. 
We will ensure that all data is maintained with confidentiality and will assure 
subjects of this when they begin the study. If subjects are not comfortable with 
disclosing any of the information that is asked in the study, they will not be 
pressured to disclose, but they may not be able to participate if the withholding 
prevents us from screening or determining eligibility in the study. All PHI (DOB, 
name, health information) will be stored in the locked office of the Principal 
Investigator (Dr. Maria K. Walker, Room 236, HSB1). The videos, audio, and 
photographs taken for UserWise to evaluate the usability of the product will allow 
identification of subjects, and they will be informed of this when they sign the IC. 
However, the UserWise company will receive the data in a secure transmission and 
the data will be viewed on a need-to-know basis by employees of the company. If 
subjects are uncomfortable with being identifiable to UserWise employees, they 
can opt out of the recordings in the training and will still be able to participate.  
 
20.2 Describe what steps you will take to make the subjects feel at ease with the 
research situation in terms of the questions being asked and the procedures 
being performed. “At ease” does not refer to physical discomfort, but the 
sense of intrusiveness a subject might experience in response to questions, 
examinations, and procedures. 
Subjects will only be asked questions that are relevant to the study and their ocular 
health.  The investigators, who are all optometrists at the UEI that regularly see 
patients and communicate about potentially sensitive information, have been 
trained to develop proper rapport with patients and study subjects. All investigators 
will make every effort to avoid seeming intrusive when asking the subjects 
questions.  
 

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System on the Continued Efficacy of Tangible HydraPEG Rigid Gas Permeable 
Contact Lens Coating. 
 
Page 20 of 22 
Revised: July 24, 2017 
21.0 Informed Consent Process 
Informed consent must be obtained from all subjects, unless a waiver or 
alteration is approved by the IRB (see below). 
21.1 Indicate whether you will you be obtaining consent, and if so describe: 
Informed consent will be obtained before any testing is done. The subject will be provided 
an informed consent document written in non-technical language. The study staff will 
review the document with the subject and will give the subject adequate time to review the 
form and ask any questions before deciding whether to participate. After answering any 
questions, the study staff will invite the subject to participate in the study and will have the 
subject sign the consent form. The investigators and key personnel associated with the 
informed consent process are trained to not influence the participant in their decision to 
participate in the research or not. The individual may choose not to sign the consent form 
without any coercion from the study personnel. Students will be informed that their 
participation is voluntary and will not affect their academic standing. Staff and faculty will 
also be informed that their participation is voluntary and will not affect their employment 
status. Non-participation in the study from patients will not impact future care. See the 
Informed Consent document in the appendix. Informed consent is estimated to take 
approximately 35 minutes for this study. 
 
22.0 Process to Document Consent in Writing 
We will be following “SOP: Written Documentation of Consent (HRP-
091).”  
 
23.0 HIPAA 
The HIPAA AUTHORIZATION form is attached. 
24.0 FERPA – N/A 
 
25.0 Data Management 
25.1 Describe the data analysis plan, including any statistical procedures. 
Data will be stored in a study paper file. Paper files will be kept in a filing cabinet within 
The Ocular Surface Institute (Health and Biomedical Sciences Building). Electronic data 
will be stored on a password-protected computer in a locked office in rooms 232, 236 or 
250 within The Ocular Surface Institute of the Health Biological Sciences Building 
(HBSB). All study data will remain on UH property within The Ocular Surface Institute for 
a minimum of 3 years following study completion. The principal investigator will be 

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System on the Continued Efficacy of Tangible HydraPEG Rigid Gas Permeable 
Contact Lens Coating. 
 
Page 21 of 22 
Revised: July 24, 2017 
responsible for maintaining study data security and subject confidentiality, and the PI and 
the study coordinator will be responsible for receipt and transmission of the data. The 
investigative team, study sponsor and inspectors from regulatory agencies such as the US 
Food and Drug Administration will have access to the data if requested for study 
monitoring or an audit.  
 
All collected data will be documented on study documents and analyzed for differences 
between baseline and test data. Hypothesis testing will be performed using statistical 
analyses including parametric or nonparametric comparisons (i.e., t-tests, signed-rank 
tests), analysis of variance, general linear models, correlation, or regression techniques. 
 
The recorded audio and video data will be sent to UserWise for analysis of the 
usability of the product.  
 
26.0 Specimen Use and Banking – N/A 
 
27.0 Community-Based Participatory Research – N/A  
 
28.0 Sharing of Results with Subjects 
28.1 Describe whether results (study results or individual subject results, such as 
results of investigational diagnostic tests, genetic tests, or incidental 
findings) will be shared with subjects or others. 
Study results will not be shared with subjects, unless the investigator feels that the 
subject should know something about the ocular health of their eye as a result of 
the study.  
 
29.0 Resources  
29.1 Describe the qualifications (e.g., training, experience, oversight) of you and 
your staff as required to perform your/their roles.  
All investigators in this study are Optometrists, and are qualified to examine 
subjects and evaluate the performance of the contact lenses. The investigators all 
have experience working within The Ocular Surface Institute, and with all the 
exam rooms, equipment, and data storage rooms. All investigators have completed 
the necessary training for good clinical practices, and are specialists in corneal and 
scleral lens fitting and management.  The study coordinator is an experienced 
coordinator at TOSI whose primary role is to coordinate studies such as this one. 

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System on the Continued Efficacy of Tangible HydraPEG Rigid Gas Permeable 
Contact Lens Coating. 
 
Page 22 of 22 
Revised: July 24, 2017 
She is also trained on IRB practices and is experienced with informed consent 
processes and confidentiality.   
29.2 Describe other resources available to conduct the research: For example, 
as appropriate: 
We do not expect to have difficulty recruiting subjects in this study. Most of our 
subjects will come from the patients in the clinic at the University Eye Institute at 
UHCO. We estimate that we have access to about 200 potential subjects that we 
expect to fit our eligibility criteria.  
 
30.0 Additional Approvals 
• 
N/A 
 

Eligibility	  Screening	  /Recruitment	  Script	  for	  the	  Tangible	  Boost	  
Study	  
	  
Once	  the	  patient	  has	  specified	  that	  they	  are	  interested	  in	  obtaining	  more	  
information	  about	  the	  study,	  the	  investigator	  will	  give	  an	  overview	  of	  the	  study,	  
including	  all	  of	  the	  following	  points:	  
	  
-­‐ 
The	  purpose	  of	  this	  study	  is	  to	  compare	  the	  vision	  and	  comfort	  differences	  
between	   rigid	   lenses	   that	   are	   coated	   with	   HydraPEG	   and	   treated	   with	  
Tangible	  Boost	  replenishing	  system,	  and	  those	  that	  are	  coated	  and	  treated	  
with	  the	  placebo	  system.	  	  
-­‐ 
HydraPEG	  is	  a	  new	  coating	  that	  is	  bonded	  to	  regular	  contact	  lenses	  and	  may	  
improve	   comfort	   and	   vision	   with	   rigid	   contact	   lenses.	   	   HydraPEG	   is	  
composed	  of	  approximately	  90%	  water,	  and	  the	  remaining	  components	  are	  
wetting	  and	  viscosity	  agents	  that	  are	  used	  in	  several	  eye	  drops	  to	  improve	  
wettability	   and	   tear	   film	   surface	   integrity.	   This	   coating	   is	   approved	   by	   the	  
FDA,	  but	  it	  is	  known	  to	  deplete	  over	  time.	  The	  new	  Tangible	  Boost	  system	  is	  a	  
solution	  that	  coated	  lenses	  will	  be	  stored	  in	  overnight	  every	  30	  days,	  in	  order	  
to	  replenish	  the	  coating.	  
-­‐ 
We	  are	  recruiting	  patients	  who	  are	  habitual	  wearers	  of	  rigid	  contact	  lenses	  
(either	  scleral	  or	  corneal)	  
	  
	  After	   giving	   a	   brief	   overview	   of	   the	   study,	   the	   investigator	   will	   ask	   the	   potential	  
subject:	  
	  
1. Are	  you	  interested	  in	  hearing	  about	  what	  your	  role	  would	  be	  if	  you	  qualify	  
for	  the	  study?	  	  
	  
	  
	  
	  
Yes	  (move	  on)	  
	  
	  
No	  (stop)	  
	  
-­‐ 
If	  you	  decide	  to	  be	  a	  subject	  in	  this	  study,	  you	  will	  be	  asked	  to	  come	  in	  to	  the	  
University	  Eye	  Institute	  on	  approximately	  5	  occasions,	  over	  a	  period	  of	  about	  
5	  months.	  	  
-­‐ 
The	  initial	  visit	  is	  so	  that	  we	  can	  evaluate	  your	  current	  lenses,	  and	  have	  you	  
fit	  with	  the	  study	  lenses.	  	  
-­‐ 
When	   you	   arrive	   that	   first	   day,	   a	   series	   of	   images	   will	   be	   taken	   of	   your	  
habitual	  lenses,	  and	  the	  lenses	  will	  be	  removed	  so	  that	  you	  can	  try	  on	  the	  
study	  lenses	  to	  be	  sure	  they	  fit	  properly	  and	  offer	  you	  good	  vision.	  	  
-­‐ 
At	  the	  second	  visit,	  the	  lenses	  will	  have	  been	  ordered	  and	  coated	  with	  the	  
HydraPEG	  coating.	  At	  this	  time,	  if	  the	  lenses	  are	  not	  adequate	  we	  will	  have	  to	  
re-­‐order	  the	  study	  lenses,	  so	  you	  will	  not	  be	  given	  them	  that	  day.	  If	  this	  is	  the	  
case,	   you	   will	   be	   asked	   to	   return	   for	   an	   additional	   visit	   to	   evaluate	   and	  
dispense	  the	  re-­‐ordered	  study	  lenses.	  	  

-­‐ 
After	   the	   visit	   in	   which	   the	   study	   lenses	   are	   deemed	   dispensable,	   you	   will	  
wear	  the	  study	  lenses,	  cleaning	  and	  storing	  them	  with	  Unique	  pH	  cleaning	  
system,	  for	  30	  days.	  
-­‐ 
After	  30	  days,	  you	  will	  be	  asked	  to	  come	  in	  for	  the	  third	  visit,	  similar	  to	  the	  
initial	  Visit.	  When	  you	  arrive	  for	  the	  3rd	  visit	  you	  will	  have	  the	  same	  vision	  
and	   image	   testing	   done	   that	   was	   done	   at	   the	   initial	   visit.	   You	   will	   then	   be	  
given	  a	  solution	  to	  store	  your	  lenses	  in	  overnight	  –	  you	  will	  be	  given	  either	  
the	  tangible	  boost	  replenishing	  system,	  or	  the	  placebo	  (unique	  pH)	  –	  which	  
you	  will	  be	  asked	  to	  store	  your	  lenses	  in	  that	  evening.	  	  
-­‐ 
The	   day	   after	   the	   boost	   dispense,	   you	   will	   return	   to	   the	   ocular	   surface	  
institute	  to	  go	  through	  the	  same	  evaluation	  of	  the	  lenses	  that	  you	  underwent	  
at	  the	  previous	  visit.	  At	  that	  point	  you	  will	  be	  asked	  to	  wear	  your	  lenses	  for	  
another	  60	  days	  (storing	  your	  lenses	  in	  the	  test	  solution	  at	  the	  midpoint	  30	  
days	  between).	  
-­‐ 
You	  will	  be	  asked	  to	  come	  in	  for	  the	  5th	  and	  final	  visit	  approximately	  90	  days	  
after	   you	   initially	   are	   given	   the	   HydraPEG	   lenses.	   At	   this	   point	   the	   same	  
testing	  will	  be	  done,	  and	  then	  you	  will	  be	  asked	  to	  return	  the	  lenses	  to	  the	  
investigators	  and	  the	  study	  will	  end.	  
	  
After	   giving	   the	   potential	   subject	   an	   overview	   of	   their	   role	   in	   the	   study,	   the	  
investigator	  will	  ask:	  
	  
Q1.	  Do	  you	  wear	  rigid	  contact	  lenses	  as	  your	  primary	  mode	  of	  vision	  correction?	  (if	  
yes,	  continue	  to	  Q2)	  
	  
	  
	  
	  
	  
	  
	  
Yes	  
	  
	  
No	  
	  
Q2.	  Do	  you	  have	  any	  eye	  conditions	  that	  you	  know	  of?	  
	  
	  
	  
	  
	  
	  
	  
	  
Yes	  
	  
	  
No	  
If	  yes,	  name	  them:	  
	  
	  
	  
_____________________________________________________________________	  
	  
note:	  patients	  will	  probably	  name	  the	  condition	  that	  they	  are	  being	  prescribed	  
rigid	  lenses	  to	  treat.	  These	  conditions	  are	  allowed;	  exclusions	  are	  only	  if	  the	  
patient	  has	  other	  ocular	  disease	  that	  could	  confound	  the	  data.	  
	  
Q3:	  Do	  you	  have	  any	  allergies	  to	  eye	  drops	  that	  you	  are	  aware	  of?	  Additionally,	  do	  
you	  know	  of	  any	  allergies	  you	  have	  to	  the	  following	  substances:	  Dextran,	  
polyethylene glycol,	  hydroxypropyl methylcellulose, or polyvinyl alcohol?	  
	  
Yes	  
	  
	  
No	  
If	  no	  to	  both	  parts,	  continue	  to	  Q4.	  
	  
Q4:	  As	  far	  as	  you	  know,	  are	  you	  allergic	  to	  Unique	  pH	  multipurpose	  GP	  lens	  cleaner?	  
Yes	  
	  
	  
No	  
If	  no,	  they	  qualify	  for	  the	  study.	  

	  
	  
At	  this	  point,	  if	  the	  patient	  is	  still	  interested	  in	  participating	  in	  the	  study,	  the	  
investigator	  can	  begin	  the	  formal	  Informed	  Consent	  process.	  	  
	  

Instructions for Contact lens Handling: 
 
- Clean lenses with Unique pH 
- Store lenses in Unique pH 
- Rinse lenses (if needed) with Purilens or Unique 
pH 
- Do not use tap water on lenses 

Patient Survey: Lens Dispense Visit 
Patient ID: 
Date: 
Visit #:  
 
 
Please rate on the scale below how comfortable your habitual lenses are upon insertion on an average day? 
 
 
 
 
 
Please rate on the scale below how comfortable your habitual lenses are at the end of the day on an average day? 
 
 
 
 
 
Please rate on the scale below what the quality of your vision is on an average day with your habitual lenses? 
 
 
 
 
 
 
 
On average, how many hours each day can you comfortably wear your habitual lenses?  _________________ 
 
 
 
 
 
 
Comments: 
 
extremely uncomfortable  
extremely comfortable 
extremely uncomfortable  
extremely comfortable 
Poor vision, unable to 
function  
Excellent vision, no 
awareness of blue 

Patient Survey: Boost Dispense Visit 
Patient ID: 
Date: 
Visit #:  
 
Please rate on the scale below how comfortable the Hydra-PEG study lenses are upon insertion on an 
average day? 
 
 
 
 
 
Please rate on the scale below how comfortable the Hydra-PEG study lenses are at the end of the day 
on an average day? 
 
 
 
 
 
Please rate on the scale below what the quality of your vision is on an average day with the Hydra-PEG 
study lenses? 
 
 
 
 
 
 
 
On average, how many hours each day can you comfortably wear the Hydra-PEG study lenses?   
 
_________________ 
extremely uncomfortable  
extremely comfortable 
extremely uncomfortable  
extremely comfortable 
Poor vision, unable to 
function  
Excellent vision, no 
awareness of blue 

 
 
 
 
 
Comments: 

Patient Survey: Initial Boost Follow-Up Visit 
Patient ID: 
Date: 
Visit #: 
 
Please rate on the scale below how comfortable the study lenses were upon insertion today? 
 
 
 
 
 
 
Please rate on the scale below what the quality of your vision today with the study lenses? 
 
 
 
 
 
 
Do you prefer the current Hydra-PEG lenses or your habitual lenses that you wore prior to this study 
(circle one)? 
 
Hydra-PEG lenses 
 
 
Habitual lenses  
 
 
No preference 
 
Did you prefer the Hydra-PEG lenses before or after the Boost treatment (circle one)? 
 
Hydra-PEG lenses pre-Boost 
 
Hydra-PEG lenses post-Boost 
 
 
No preference 
 
Comments: 
 
extremely uncomfortable  
extremely comfortable 
Poor vision, unable to 
function  
Excellent vision, no 
awareness of blue 

Patient Survey: Final Boost Follow-Up Visit 
Patient ID: 
Date: 
Visit #:  
 
Please rate on the scale below how comfortable the study lenses are upon insertion on an average day? 
 
 
 
 
 
Please rate on the scale below how comfortable the study lenses are at the end of the day on an 
average day? 
 
 
 
 
 
Please rate on the scale below what the quality of your vision is on an average day with the study 
lenses? 
 
 
 
 
 
 
 
 
extremely uncomfortable  
extremely comfortable 
extremely uncomfortable  
extremely comfortable 
Poor vision, unable to 
function  
Excellent vision, no 
awareness of blue 

Do you prefer the current Hydra-PEG lenses or your habitual lenses that you wore prior to this study 
(circle one)? 
 
Hydra-PEG lenses 
 
 
Habitual lenses  
 
 
No preference 
 
Did you prefer the Hydra-PEG lenses before or after the Boost treatment (circle one)? 
 
Hydra-PEG lenses pre-Boost 
 
Hydra-PEG lenses post-Boost 
 
 
No preference 
 
On average, how many hours per day can you comfortably wear these lenses? _______________ 
  
Comments: 
 

 
 
Evaluation of Tangible Boost Replenishing System 
 
Examiner Initials: ____________ 
 
Page 1 of 7 
 
Subject: ________________ 
 
Date: ______/_______/______ 
VISIT 1 
 
1. 
Time of Day (military time) : ____:____  
 
2. 
Signed informed consent & HIPPA: ☐1 Yes   ☐2 No   
 
3. 
Ethnicity 
☐1 Hispanic or Latino    ☐2 Not Hispanic or Latino 
 
4. 
Race 
☐1 American Indian or Alaskan Native 
☐2 Asian 
☐3 Black or African American  
☐4 Native Hawaiian or Other Pacific Islander  
☐5 White 
☐6 Other, specify __________________________________ 
 
5. 
Birthdate (mm/dd/yy): ____/____/____ 
 
 
 
6. 
Gender:  ☐1 Male 
☐2 Female 
 
7. 
Lens Indication: _____________________________ 
 
8. 
Lens Type (circle one):  
Scleral  
Corneal 
 
9. 
Duration of lens wear (months/years): ______________________________ 
 
10. 
Average # hours lens wear per week: _______________________________ 
 
11. 
Hours of lens wear today: ________________________________________ 
 
12. 
CLDEQ-8 
a. CLDEQ-8 completed and verified:  
☐1 Yes 
☐2 No  
CLDEQ-8 score: ________ 
 
13. 
VAS scale  
a. VAS scale completed and verified:  
☐1 Yes     
☐2 No   
VAS score: ____________ 
 
14. 
Medications and Medical History 
a. Current medications or supplements? 
 
 
☐1 Yes 
☐2 No 

 
 
Evaluation of Tangible Boost Replenishing System 
 
Examiner Initials: ____________ 
 
Page 2 of 7 
 
Subject: ________________ 
 
Date: ______/_______/______ 
b. Was the concomitant medication log completed? 
☐1 Yes 
☐2 No 
c. Medical or ocular conditions? 
 
 
 
☐1 Yes 
☐2 No 
d. Was the medical and ocular history log completed? 
☐1 Yes 
☐2 No 
e. History of ocular surgeries, ocular injections or laser procedures? 
 
☐1 Yes 
☐2 No (If No, skip to question 10) 
f. Was the surgery more than 12 weeks ago?  ☐1 Yes 
 
☐2 No ☐3 N/A 
g. Type of ocular surgery and when it occurred? __________________________  Date: ____ /____ 
/____ 
 
 
15. 
Contact lens history
a. Current lens brand 
OD 
_______________________________________ 
OS 
_______________________________________ 
 
b. Current lens parameters (if known) 
 
Base curve: _______________________________ 
SAG: _____________________________________ 
Diameter: _________________________________ 
Lens Power: _______________________________ 
Limbal Profile: _____________________________ 
Landing Zone Profile: ________________________ 
 
c. Did subject wear their own contact lenses 2 days prior to this appointment? ☐1 Yes ☐2 No 
 
16. 
Visual Acuity with habitual lenses (logMAR): Record # of letters seen 
 
OD: ____________ 
 
OS: OD: _____________ 
 
17. 
Over refraction (spherical only) 
OD 
___ ___.___  
OS 
___ ___.___  
 
 
 
 
 

 
 
 
Evaluation of Tangible Boost Replenishing System 
 
Examiner Initials: ____________ 
 
Page 3 of 7 
 
Subject: ________________ 
 
Date: ______/_______/______ 
 
 
18. 
Slit Lamp Evaluation of Habitual Scleral Lenses 
OD 
 
                         OS 
__________________________ 
Movement 
__________________________ 
__________________________ 
Centration 
__________________________ 
__________________________ 
Apical Clearance 
__________________________ 
__________________________ 
Limbal Clearance 
__________________________ 
__________________________ 
Scleral Landing Zone 
__________________________ 
__________________________ 
Comments 
__________________________ 
 
19. 
Perform Keratograph NIBUT 
 
OD:   NIKf-BUT “until blink” (first break up) ____________________________________ 
  
NIKavg-BUT “until blink” (average break up)_______________________________ 
 
Level: ___________________ 
 
NIKf-BUT “25 seconds” (first break up) ____________________________________ 
  
NIKavg-BUT “25 seconds” (average break up)_______________________________ 
 
Level: ___________________ 
 
 
OS:   
NIKf-BUT “until blink” (first break up) ____________________________________ 
  
NIKavg-BUT “until blink” (average break up)_______________________________ 
 
Level: ___________________ 
 
NIKf-BUT “25 seconds” (first break up) ____________________________________ 
  
NIKavg-BUT “25 seconds” (average break up)_______________________________ 
 
Level: ___________________ 
 
 
20. 
Slit lamp exam (after lens removal) 
OD 
 
                         OS 
__________________________ 
Lids and lashes 
__________________________ 
__________________________ 
Conjunctiva 
__________________________ 
__________________________ 
Sclera 
__________________________ 
__________________________ 
Cornea 
__________________________ 
__________________________ 
Iris 
__________________________ 
__________________________ 
Anterior Chamber __________________________ 

 
 
 
Evaluation of Tangible Boost Replenishing System 
 
Examiner Initials: ____________ 
 
Page 4 of 7 
 
Subject: ________________ 
 
Date: ______/_______/______ 
__________________________ 
Lens 
__________________________ 
 
21. 
Eyelid Eversion (GPC grade level: Efron Scale, circle for each eye) 
 
OD:  
Grade 0 
Grade 1 
Grade 2 
Grade 3 
Grade 4 
 
OS:  
Grade 0 
Grade 1 
Grade 2 
Grade 3 
Grade 4 
 
 
22. 
Corneal Fluorescein Staining:  
(Efron Scale for each quadrant: 0-4 grading in each quadrant, total score range 0-20) 
 
 
 
TOTAL Score: OD _____  OS ______ 
 
 
If subject is wearing scleral lenses, refit with diagnostics, if wearing corneal, order base curve and power 
based on their habitual lenses and any appreciative OR 
 
23. 
Diagnostic Fitting with Study Lenses (Scleral Only): 
 
a. Final Diagnostic Lens Parameters 
 
Base curve: _______________________________ 
Diameter: _________________________________ 
Lens Power: _______________________________ 
Limbal Profile: _____________________________ 
Landing Zone Profile: ________________________ 
 
OD 
1
2
3
4
5
OS 
1
2
4
3
5

 
 
 
Evaluation of Tangible Boost Replenishing System 
 
Examiner Initials: ____________ 
 
Page 5 of 7 
 
Subject: ________________ 
 
Date: ______/_______/______ 
b. Slit Lamp Evaluation of Diagnostic Scleral Lenses 
OD 
 
                         OS 
__________________________ 
Movement 
__________________________ 
__________________________ 
Centration 
__________________________ 
__________________________ 
Apical Clearance 
__________________________ 
__________________________ 
Limbal Clearance 
__________________________ 
__________________________ 
Scleral Landing Zone 
__________________________ 
__________________________ 
Comments 
__________________________ 
 
c. Over-refraction of diagnostic scleral lenses  
 
OD: __________________ 
 
OS: _____________________ 
 
d. Final Visual Acuity with Study Lenses (logMAR): Record # of letters seen 
 
OD: ____________ 
 
OS: OD: _____________ 
 
e. 
Final trial lenses to be ordered:  
 
Base curve: _______________________________ 
SAG: _____________________________________ 
Diameter: _________________________________ 
Lens Power: _______________________________ 
Limbal Profile: _____________________________ 
Landing Zone Profile: ________________________ 
 
a. 
Contact lens order form filled out? 
 
☐1 Yes ☐2 No 
 
b. 
Gift card given?  ☐1 Yes 
☐2 No 
 
c. 
Appointment 2 scheduled?   
☐1 Yes 
☐2 No 
 
d. 
Appointment 2 date/time: ___________________________________ 
 
 
 

 
 
 
Evaluation of Tangible Boost Replenishing System 
 
Examiner Initials: ____________ 
 
Page 6 of 7 
 
Subject: ________________ 
 
Date: ______/_______/______ 
 
 
Concomitant Medication Log (include supplements) 
Medication 
Dose Units  
Freq  
Route 
Dates of use 
Reason 
 
 
☐1 mg 
☐2 mcg 
☐3 mL 
☐4 tab 
☐5 other 
________ 
☐1  qd 
☐2  bid 
☐3 tid 
☐4 qid 
☐5 prn 
☐6 other 
________ 
☐1  po 
☐2  SC 
☐3 IM 
☐4 IV 
☐5 topical 
☐6 other 
_______ 
 
___/___/___ 
 
to 
 
___/___/___ 
 
☐ current 
☐1 Dx Med 
Condition  
☐2 Acute 
Condition 
☐3 Prophylaxis 
☐4 Supplement 
☐5 other: 
___________ 
 
 
☐1 mg 
☐2 mcg 
☐3 mL 
☐4 tab 
☐5 other 
________ 
☐1  qd 
☐2  bid 
☐3 tid 
☐4 qid 
☐5 prn 
☐6 other 
________ 
☐1  po 
☐2  SC 
☐3 IM 
☐4 IV 
☐5 topical 
☐6 other 
_______ 
 
___/___/___ 
 
to 
 
___/___/___ 
 
☐ current 
☐1 Dx Med 
Condition  
☐2 Acute 
Condition 
☐3 Prophylaxis 
☐4 Supplement 
☐5 other: 
___________ 
 
 
☐1 mg 
☐2 mcg 
☐3 mL 
☐4 tab 
☐5 other 
________ 
☐1  qd 
☐2  bid 
☐3 tid 
☐4 qid 
☐5 prn 
☐6 other 
________ 
☐1  po 
☐2  SC 
☐3 IM 
☐4 IV 
☐5 topical 
☐6 other 
_______ 
 
___/___/___ 
 
to 
 
___/___/___ 
 
☐ current 
☐1 Dx Med 
Condition  
☐2 Acute 
Condition 
☐3 Prophylaxis 
☐4 Supplement 
☐5 other: 
___________ 
 
 
☐1 mg 
☐2 mcg 
☐3 mL 
☐4 tab 
☐5 other 
________ 
☐1  qd 
☐2  bid 
☐3 tid 
☐4 qid 
☐5 prn 
☐6 other 
________ 
☐1  po 
☐2  SC 
☐3 IM 
☐4 IV 
☐5 topical 
☐6 other 
_______ 
 
___/___/___ 
 
to 
 
___/___/___ 
 
☐ current 
☐1 Dx Med 
Condition  
☐2 Acute 
Condition 
☐3 Prophylaxis 
☐4 Supplement 
☐5 other: 
___________ 
 
 
 

 
 
 
Evaluation of Tangible Boost Replenishing System 
 
Examiner Initials: ____________ 
 
Page 7 of 7 
 
Subject: ________________ 
 
Date: ______/_______/______ 
Medical and Ocular History Log (include Dry Eye and Meibomian Gland Dysfunction) 
Condition 
Date of diagnosis 
Current tx  
(check all that apply) 
State of Condition 
 
 
___/___/___ 
 
to 
 
___/___/___ 
 
☐ currently being tx 
 
☐1 Medication  
☐2 Diet/Exercise 
☐3 Monitor 
☐4 Therapy (PT, OT, 
psych) 
☐5 surgery/chemo 
☐6 behavioral change 
☐7 Impending Dx 
☐8 other: ___________ 
☐1  controlled and 
stable 
☐2  currently working 
with doctor for 
improvement 
☐3 trying new 
medication 
☐4 impending sx/chemo 
 
 
___/___/___ 
 
to 
 
___/___/___ 
 
☐ currently being tx 
 
☐1 Medication  
☐2 Diet/Exercise 
☐3 Monitor 
☐4 Therapy (PT, OT, 
psych) 
☐5 surgery/chemo 
☐6 behavioral change 
☐7 Impending Dx 
☐8 other: ___________ 
☐1  controlled and 
stable 
☐2  currently working 
with doctor for 
improvement 
☐3 trying new 
medication 
☐4 impending sx/chemo 
 
 
___/___/___ 
 
to 
 
___/___/___ 
 
☐ currently being tx 
 
☐1 Medication  
☐2 Diet/Exercise 
☐3 Monitor 
☐4 Therapy (PT, OT, 
psych) 
☐5 surgery/chemo 
☐6 behavioral change 
☐7 Impending Dx 
☐8 other: ___________ 
☐1  controlled and 
stable 
☐2  currently working 
with doctor for 
improvement 
☐3 trying new 
medication 
☐4 impending sx/chemo 
 

 
 
 
Evaluation of Tangible Boost Replenishing System 
 
Examiner Initials: ____________ 
 
Page 1 of 6 
 
Subject: ________________ 
 
Date: ______/_______/______ 
VISIT 2 
 
1. 
Time of Day (military time) : ____:____  
 
2. 
Hours of lens wear today: ________________________________________ 
 
3. 
Current Cleaning solution: ______________________________________________ 
 
4. 
CLDEQ-8 
a. CLDEQ-8 completed and verified:  
☐1 Yes 
☐2 No  
CLDEQ-8 score: ________ 
 
5. 
VAS scale  
a. VAS scale completed and verified:  
☐1 Yes     
☐2 No   
VAS score: ____________ 
b. VAS supplemental completed and verified:  
☐1 Yes     
☐2 No   
 
 
6. 
Medications  
a. Any changes in medications?  
 
 
☐1 Yes 
☐2 No 
b. If yes, please specify:______________________________________________________ 
 
 
 
*Note: Habitual lens fit does not need to be re-evaluated at this visit. They may be removed without 
evaluation.  
 
7. 
Slit lamp exam (after lens removal) 
OD 
 
                         OS 
__________________________ 
Lids and lashes 
__________________________ 
__________________________ 
Conjunctiva 
__________________________ 
__________________________ 
Sclera 
__________________________ 
__________________________ 
Cornea 
__________________________ 
__________________________ 
Iris 
__________________________ 
__________________________ 
Anterior Chamber __________________________ 
__________________________ 
Lens 
__________________________ 
 
8. 
Corneal Fluorescein Staining  
(Efron Scale for each quadrant: 0-4 grading in each quadrant, total score range 0-20) 
 

 
 
 
Evaluation of Tangible Boost Replenishing System 
 
Examiner Initials: ____________ 
 
Page 2 of 6 
 
Subject: ________________ 
 
Date: ______/_______/______ 
 
 
 
TOTAL Score: OD _____  OS ______ 
 
9. 
Fitting with Study Lenses: 
a. Visual Acuity with Study Lenses (logMAR): Record # of letters seen 
 
OD: ____________ 
 
OS: OD: _____________ 
 
b. Over refraction  
 
OD 
________________________  
OS 
________________________ 
 
c. Slit Lamp Evaluation of Study Lenses 
OD 
 
                         OS 
__________________________ 
Movement 
__________________________ 
__________________________ 
Centration 
__________________________ 
__________________________ 
Apical Clearance 
__________________________ 
__________________________ 
Limbal Clearance 
__________________________ 
__________________________ 
Scleral Landing Zone 
__________________________ 
__________________________ 
Comments 
__________________________ 
 
10. Comments and suggested changes to lens parameters:  
 
 
 
 
11. Need for New Lens order?  ☐1 Yes 
☐2 No  
☐3 Maybe 
 
 
 
OD 
1
2
3
4
5
OS 
1
2
4
3
5

 
 
 
Evaluation of Tangible Boost Replenishing System 
 
Examiner Initials: ____________ 
 
Page 3 of 6 
 
Subject: ________________ 
 
Date: ______/_______/______ 
12. New lenses to be ordered (if applicable, if not leave blank):  
 
Base curve: _______________________________ 
SAG: _____________________________________ 
Diameter: _________________________________ 
Lens Power: _______________________________ 
Limbal Profile: _____________________________ 
Landing Zone Profile: ________________________ 
13. Keratograph performed (only if lenses are dispensable)?  ☐1 Yes 
☐2 No  
14. Perform Keratograph NIBUT  
 
OD:   NIKf-BUT “until blink” (first break up) ____________________________________ 
  
NIKavg-BUT “until blink” (average break up)_______________________________ 
 
Level: ___________________ 
 
NIKf-BUT “25 seconds” (first break up) ____________________________________ 
  
NIKavg-BUT “25 seconds” (average break up)_______________________________ 
 
Level: ___________________ 
 
 
OS:   
NIKf-BUT “until blink” (first break up) ____________________________________ 
  
NIKavg-BUT “until blink” (average break up)_______________________________ 
 
Level: ___________________ 
 
NIKf-BUT “25 seconds” (first break up) ____________________________________ 
  
NIKavg-BUT “25 seconds” (average break up)_______________________________ 
 
Level: ___________________ 
 
 
15. Contact lens order form filled out? ☐1 Yes     ☐2 No    ☐3 Not Applicable 
 
16. Gift card given? 
 
 ☐1 Yes 
☐2 No 
 
17. Dispensed Lenses? 
 
 ☐1 Yes 
☐2 No 
 

 
 
 
Evaluation of Tangible Boost Replenishing System 
 
Examiner Initials: ____________ 
 
Page 4 of 6 
 
Subject: ________________ 
 
Date: ______/_______/______ 
18. Dispensed Unique pH?  
 ☐1 Yes 
☐2 No 
 
19. Dispensed DMV? 
  
☐1 Yes  
☐2 No 
 
20. Dispensed PuriLens?   
☐1 Yes 
☐2 No 
 
21. Lens Dispense log filled out? ☐1 Yes 
 
☐2 No 
 
22. Follow up appt made (30 days and +1 day)? ☐1 Yes 
☐2 No 
 
23. Follow up appt dates:  Appt 4 date: ________________________________ 
 
  Appt 5 date: ________________________________ 
 
 
 
 

 
 
 
Evaluation of Tangible Boost Replenishing System 
 
Examiner Initials: ____________ 
1 
 
Subject: ________________ 
 
Date: ______/_______/______ 
VISIT 3 
 
1. 
Time of Day (military time) : ____:____  
 
2. 
Hours of Rigid lens wear today: ________________________________________ 
 
3. 
Current Cleaning solution: ______________________________________________ 
 
4. 
Currently wearing study lenses?    ☐1 Yes  
☐2 No 
 
5. 
CLDEQ-8 
a. CLDEQ-8 completed and verified:  
☐1 Yes 
☐2 No  
CLDEQ-8 score: ________ 
 
6. 
VAS scale  
a. VAS scale completed and verified:  
☐1 Yes     
☐2 No   
VAS score: ____________ 
 
b. Extended VAS scale completed:   
☐1 Yes     
☐2 No   
insertion: ____________ 
 
 
 
 
 
 
☐1 Yes     
☐2 No   
removal: ____________ 
 
 
 
 
 
 
☐1 Yes     
☐2 No   
vision: ____________ 
 
 
 
 
 
 
 
☐1 Yes     
☐2 No   
Hrs Score: ____________ 
 
7. 
Medications  
a. Any changes in medications?  
 
 
☐1 Yes 
☐2 No 
b. If yes, please specify:______________________________________________________ 
 
 
8. 
Visual Acuity with Study Lenses (logMAR): Record # of letters seen 
 
OD: ____________ 
 
OS: _____________ 
 
9. 
Over refraction (spherical only) 
OD 
_____________ 
OS 
_____________ 
 
10. 
Slit Lamp Evaluation of Study Lenses 
OD 
 
                         OS 
__________________________ 
Movement 
__________________________ 
__________________________ 
Centration 
__________________________ 
__________________________ 
Apical Clearance 
__________________________ 

 
 
 
Evaluation of Tangible Boost Replenishing System 
 
Examiner Initials: ____________ 
2 
 
Subject: ________________ 
 
Date: ______/_______/______ 
__________________________ 
Limbal Clearance 
__________________________ 
__________________________ 
Scleral Landing Zone 
__________________________ 
__________________________ 
Comments 
__________________________ 
 
 
11. 
Perform Keratograph NIBUT 
 
OD:   NIKf-BUT “until blink” (first break up) ____________________________________ 
  
NIKavg-BUT “until blink” (average break up)_______________________________ 
 
Level: ___________________ 
 
NIKf-BUT “25 seconds” (first break up) ____________________________________ 
  
NIKavg-BUT “25 seconds” (average break up)_______________________________ 
 
Level: ___________________ 
 
 
OS:   
NIKf-BUT “until blink” (first break up) ____________________________________ 
  
NIKavg-BUT “until blink” (average break up)_______________________________ 
 
Level: ___________________ 
 
NIKf-BUT “25 seconds” (first break up) ____________________________________ 
  
NIKavg-BUT “25 seconds” (average break up)_______________________________ 
 
Level: ___________________ 
 
 
12. 
Are lenses still adequate to be worn? ☐1 Yes 
 
☐2 No 
 
If no, please indicated parameter changes indicated below: 
 
 
 
 
 
13. 
Tangible Boost Training and Video recording 
a. Video file name (camera) _______________________________________ 
b. Video file name (go-pro) ________________________________________ 
c. Videos uploaded to share drive?  
☐1 Yes 
☐2 No 

 
 
 
Evaluation of Tangible Boost Replenishing System 
 
Examiner Initials: ____________ 
3 
 
Subject: ________________ 
 
Date: ______/_______/______ 
d. Videos uploaded to Dropbox?  
☐1 Yes 
☐2 No 
 
14. 
Tangible Boost or Placebo Kit Training 
 
a. Boost/Placebo dispensed?  ☐1 Yes 
☐2 No 
b. Boost Log form filled out?  
☐1 Yes 
☐2 No 
c. Boost Lot #: ______________ 
 
 
15. 
Removal of lenses and Slit lamp exam (after lens removal) 
OD 
 
                         OS 
__________________________ 
Lids and lashes 
__________________________ 
__________________________ 
Conjunctiva 
__________________________ 
__________________________ 
Sclera 
__________________________ 
__________________________ 
Cornea 
__________________________ 
__________________________ 
Iris 
__________________________ 
__________________________ 
Anterior Chamber __________________________ 
__________________________ 
Lens 
__________________________ 
 
 
 
16. 
Corneal Fluorescein Staining (0-4 grading) 
 
 
TOTAL Score: OD _____  OS ______ 
 
 
17. 
Dispensed Unique pH?  
 ☐1 Yes 
☐2 No 
 
18. 
Dispensed DMV? 
  
☐1 Yes  
☐2 No 
 
19. 
Dispensed PuriLens?   
☐1 Yes 
☐2 No 
 
OD 
1
2
3
4
5
OS 
1
2
4
3
5

 
 
 
Evaluation of Tangible Boost Replenishing System 
 
Examiner Initials: ____________ 
4 
 
Subject: ________________ 
 
Date: ______/_______/______ 
20. 
Gift card given? 
 ☐1 Yes 
☐2 No 
 
21. 
Follow up appt in 1 day? 
 ☐1 Yes 
☐2 No 
 
22. 
Follow up appt date: ________________________________ 
 
 
 

 
 
 
Evaluation of Tangible Boost Replenishing System 
 
Examiner Initials: ____________ 
1 
 
Subject: ________________ 
 
Date: ______/_______/______ 
VISIT 4 
 
1. 
Time of Day (military time) : ____:____  
 
2. 
Hours of lens wear today: ________________________________________ 
 
3. 
Current Cleaning solution: ______________________________________________ 
 
4. 
Currently wearing study lenses?    ☐1 Yes  
☐2 No 
 
5. 
CLDEQ-8 
a. CLDEQ-8 completed and verified:  
☐1 Yes 
☐2 No  
CLDEQ-8 score: ________ 
 
6. 
VAS scale  
a. VAS scale completed and verified:  
☐1 Yes     
☐2 No   
VAS score: ____________ 
 
b. Extended VAS scale completed:   
☐1 Yes     
☐2 No   
insertion: ____________ 
 
 
 
 
 
 
☐1 Yes     
☐2 No   
removal: ____________ 
 
 
 
 
 
 
☐1 Yes     
☐2 No   
vision: ____________ 
 
 
 
 
 
 
 
☐1 Yes     
☐2 No   
Hrs Score: ____________ 
 
7. 
Medications  
a. Any changes in medications?  
 
 
☐1 Yes 
☐2 No 
b. If yes, please specify:______________________________________________________ 
 
 
8. 
Visual Acuity with Study Lenses (logMAR): Record # of letters seen 
 
OD: ____________ 
 
OS: _____________ 
 
9. 
Over refraction (spherical only) 
OD 
_____________ 
OS 
_____________ 
 
 
 
 
 
 

 
 
 
Evaluation of Tangible Boost Replenishing System 
 
Examiner Initials: ____________ 
2 
 
Subject: ________________ 
 
Date: ______/_______/______ 
10. 
Slit Lamp Evaluation of Study Lenses 
OD 
 
                         OS 
__________________________ 
Movement 
__________________________ 
__________________________ 
Centration 
__________________________ 
__________________________ 
Apical Clearance 
__________________________ 
__________________________ 
Limbal Clearance 
__________________________ 
__________________________ 
Scleral Landing Zone 
__________________________ 
__________________________ 
Comments 
__________________________ 
 
 
11. 
Perform Keratograph NIBUT 
 
OD:   NIKf-BUT “until blink” (first break up) ____________________________________ 
  
NIKavg-BUT “until blink” (average break up)_______________________________ 
 
Level: ___________________ 
 
NIKf-BUT “25 seconds” (first break up) ____________________________________ 
  
NIKavg-BUT “25 seconds” (average break up)_______________________________ 
 
Level: ___________________ 
 
 
OS:   
NIKf-BUT “until blink” (first break up) ____________________________________ 
  
NIKavg-BUT “until blink” (average break up)_______________________________ 
 
Level: ___________________ 
 
NIKf-BUT “25 seconds” (first break up) ____________________________________ 
  
NIKavg-BUT “25 seconds” (average break up)_______________________________ 
 
Level: ___________________ 
 
 
12. 
Slit lamp exam (after lens removal) 
OD 
 
                         OS 
__________________________ 
Lids and lashes 
__________________________ 
__________________________ 
Conjunctiva 
__________________________ 
__________________________ 
Sclera 
__________________________ 
__________________________ 
Cornea 
__________________________ 
__________________________ 
Iris 
__________________________ 
__________________________ 
Anterior Chamber __________________________ 
__________________________ 
Lens 
__________________________ 

 
 
 
Evaluation of Tangible Boost Replenishing System 
 
Examiner Initials: ____________ 
3 
 
Subject: ________________ 
 
Date: ______/_______/______ 
 
 
13. 
Corneal Fluorescein Staining (0-4 grading) 
 
 
TOTAL Score: OD _____  OS ______ 
 
 
14. 
Are lenses still adequate to be worn? ☐1 Yes 
 
☐2 No 
 
 
If no, please indicated parameter changes indicated below: 
 
 
 
 
 
15. Gift card given? 
 ☐1 Yes 
☐2 No 
 
16.  Dispensed Unique pH?  
 ☐1 Yes 
☐2 No 
 
17. Dispensed DMV? 
  
☐1 Yes  
☐2 No 
 
18. Dispensed PuriLens?   
☐1 Yes 
☐2 No 
 
19. Follow up appt made (60 days)? 
  
☐1 Yes 
☐2 No 
 
20. Call-log filled out for 30 days (reminder)? ☐1 Yes 
☐2 No 
 
21. Follow up appt date: ________________________________ 
 
 
 
OD 
1
2
3
4
5
OS 
1
2
4
3
5

 
 
 
Evaluation of Tangible Boost Replenishing System 
 
Examiner Initials: ____________ 
1 
 
Subject: ________________ 
 
Date: ______/_______/______ 
VISIT 5 
 
1. 
Time of Day (military time) : ____:____  
 
2. 
Hours of Rigid lens wear today: ________________________________________ 
 
3. 
Current Cleaning solution: ______________________________________________ 
 
4. 
Currently wearing study lenses?    ☐1 Yes  
☐2 No 
 
5. 
CLDEQ-8 
a. CLDEQ-8 completed and verified:  
☐1 Yes 
☐2 No  
CLDEQ-8 score: ________ 
 
6. 
VAS scale  
a. VAS scale completed and verified:  
☐1 Yes     
☐2 No   
VAS score: ____________ 
 
b. Extended VAS scale completed:   
☐1 Yes     
☐2 No   
insertion: ____________ 
 
 
 
 
 
 
☐1 Yes     
☐2 No   
removal: ____________ 
 
 
 
 
 
 
☐1 Yes     
☐2 No   
vision: ____________ 
 
 
 
 
 
 
 
☐1 Yes     
☐2 No   
Hrs Score: ____________ 
 
7. 
Medications  
a. Any changes in medications?  
 
 
☐1 Yes 
☐2 No 
b. If yes, please specify:______________________________________________________ 
 
 
8. 
Visual Acuity with Study Lenses (logMAR): Record # of letters seen 
 
OD: ____________ 
 
OS: _____________ 
 
9. 
Over refraction (spherical only) 
OD 
_____________ 
OS 
_____________ 
 
 
 
 
 
 

 
 
 
Evaluation of Tangible Boost Replenishing System 
 
Examiner Initials: ____________ 
2 
 
Subject: ________________ 
 
Date: ______/_______/______ 
10. 
Slit Lamp Evaluation of Study Lenses 
OD 
 
                         OS 
__________________________ 
Movement 
__________________________ 
__________________________ 
Centration 
__________________________ 
__________________________ 
Apical Clearance 
__________________________ 
__________________________ 
Limbal Clearance 
__________________________ 
__________________________ 
Scleral Landing Zone 
__________________________ 
__________________________ 
Comments 
__________________________ 
 
 
11. 
Perform Keratograph NIBUT 
 
OD:   NIKf-BUT “until blink” (first break up) ____________________________________ 
  
NIKavg-BUT “until blink” (average break up)_______________________________ 
 
Level: ___________________ 
 
NIKf-BUT “25 seconds” (first break up) ____________________________________ 
  
NIKavg-BUT “25 seconds” (average break up)_______________________________ 
 
Level: ___________________ 
 
 
OS:   
NIKf-BUT “until blink” (first break up) ____________________________________ 
  
NIKavg-BUT “until blink” (average break up)_______________________________ 
 
Level: ___________________ 
 
NIKf-BUT “25 seconds” (first break up) ____________________________________ 
  
NIKavg-BUT “25 seconds” (average break up)_______________________________ 
 
Level: ___________________ 
 
 
12. 
Slit lamp exam (after lens removal) 
OD 
 
                         OS 
__________________________ 
Lids and lashes 
__________________________ 
__________________________ 
Conjunctiva 
__________________________ 
__________________________ 
Sclera 
__________________________ 
__________________________ 
Cornea 
__________________________ 
__________________________ 
Iris 
__________________________ 
__________________________ 
Anterior Chamber __________________________ 
__________________________ 
Lens 
__________________________ 

 
 
 
Evaluation of Tangible Boost Replenishing System 
 
Examiner Initials: ____________ 
3 
 
Subject: ________________ 
 
Date: ______/_______/______ 
 
13. 
Corneal Fluorescein Staining (0-4 grading) 
 
 
TOTAL Score: OD _____  OS ______ 
 
 
14. 
Gift card given? 
 ☐1 Yes 
☐2 No 
 
 
 
OD 
1
2
3
4
5
OS 
1
2
4
3
5

 
 
 
Evaluation of Tangible Boost Replenishing System 
 
Examiner Initials: ____________ 
 
Page 1 of 6 
 
Subject: ________________ 
 
Date: ______/_______/______ 
OPTIONAL VISIT FOR LENS RE-FITTING 
(TO BE USED IF THERE ARE FOLLOW-UP VISITS NEEDED FOR PROPER 
LENS FIT) 
 
1. 
Time of Day (military time) : ____:____  
 
2. 
Hours of Rigid lens wear today: ________________________________________ 
 
3. 
Current Cleaning solution: ______________________________________________ 
 
4. 
Currently wearing study lenses?     
☐1 Yes (if yes, evaluate lenses and then remove and apply new lenses) 
 
 
☐2 No (if no, apply study lenses) 
 
 
5. 
Slit Lamp Evaluation of Study Lenses (check which lenses are being evaluated) 
___________ test lenses if dispensed at last visit 
___________ test lenses applied today 
___________ habitual lenses 
 
OD 
 
                         OS 
__________________________ 
Movement 
__________________________ 
__________________________ 
Centration 
__________________________ 
__________________________ 
Apical Clearance 
__________________________ 
__________________________ 
Limbal Clearance 
__________________________ 
__________________________ 
Scleral Landing Zone 
__________________________ 
__________________________ 
Comments 
__________________________ 
 
 
6. 
(OPTIONAL) Slit Lamp Evaluation of Study Lenses (only to be used if test lenses for dispense were not 
evaluated above)         ___________ test lenses applied today 
 
OD 
 
                         OS 
__________________________ 
Movement 
__________________________ 
__________________________ 
Centration 
__________________________ 
__________________________ 
Apical Clearance 
__________________________ 
__________________________ 
Limbal Clearance 
__________________________ 
__________________________ 
Scleral Landing Zone 
__________________________ 
__________________________ 
Comments 
__________________________ 

 
 
 
Evaluation of Tangible Boost Replenishing System 
 
Examiner Initials: ____________ 
 
Page 2 of 6 
 
Subject: ________________ 
 
Date: ______/_______/______ 
7. 
Visual Acuity with study lenses that are being dispensed (logMAR) 
 
OD: ____________ 
 
OS: _____________ 
 
8. 
Perform Keratograph NIBUT (to be performed only if lenses will be dispensed today) 
 
OD:   NIKf-BUT “until blink” (first break up) ____________________________________ 
  
NIKavg-BUT “until blink” (average break up)_______________________________ 
 
Level: ___________________ 
 
NIKf-BUT “25 seconds” (first break up) ____________________________________ 
  
NIKavg-BUT “25 seconds” (average break up)_______________________________ 
 
Level: ___________________ 
 
 
OS:   
NIKf-BUT “until blink” (first break up) ____________________________________ 
  
NIKavg-BUT “until blink” (average break up)_______________________________ 
 
Level: ___________________ 
 
NIKf-BUT “25 seconds” (first break up) ____________________________________ 
  
NIKavg-BUT “25 seconds” (average break up)_______________________________ 
 
Level: ___________________ 
 
9. 
Indicate CL design parameter changes needed 
 
 
 
 
 
 
10. 
Gift card given (should be no)? 
 ☐1 Yes 
☐2 No 
 
 

Copyright© Trustees of Indiana University, 2009, all rights reserved 
CONTACT LENS QUESTIONNAIRE-8  
(CLDEQ-8) 
 
 
 
1. Questions about EYE DISCOMFORT: 
 
a. During a typical day in the past week, how often 
did your eyes feel discomfort while wearing 
your contact lenses? 
 
 
 
0 
Never  
 
 
1 
Rarely 
 
 
2 
Sometimes 
 
 
3 
Frequently 
 
 
4 
Constantly 
 
When your eyes felt discomfort with your contact 
lenses, how intense was this feeling of 
discomfort… 
 
b.   At the end of your wearing time? 
 
Never 
Not at All 
 
 
Very 
have it Intense  
 
 
Intense 
0 
 
1 
2 
3 
4 
5 
 
 
2. Questions about EYE DRYNESS: 
 
a. During a typical day in the past week while 
wearing your contact lenses, how often did 
your eyes feel dry? 
 
 
 
0 
Never  
 
 
1 
Rarely 
 
 
2 
Sometimes 
 
 
3 
Frequently 
 
 
4 
Constantly 
 
 
When your eyes felt dry, how intense was this 
feeling of dryness… 
 
b. At the end of your wearing time? 
 
Never 
Not at All 
 
 
Very 
have it Intense  
 
 
Intense 
0 
 
1 
2 
3 
4 
5 
 
 
 
 
 
 
3. Questions about CHANGEABLE, BLURRY 
VISION: 
a. During a typical day in the past week, how often 
did your vision change between clear and blurry 
or foggy while wearing your contact lenses? 
 
 
 
0 
Never  
 
 
1 
Rarely 
 
 
2 
Sometimes 
 
 
3 
Frequently 
 
 
4 
Constantly 
 
When your vision was blurry, how noticeable was 
the changeable, blurry, or foggy vision … 
 
b. At the end of your wearing time? 
 
Never 
Not at All 
 
 
Very 
have it Intense  
 
 
Intense 
0 
 
1 
2 
3 
4 
5 
 
 
4. Question about CLOSING YOUR EYES: 
During a typical day in the past week, how often did 
your eyes bother you so much that you wanted to 
close them? 
 
 
 
0 
Never  
 
 
1 
Rarely 
 
 
2 
Sometimes 
 
 
3 
Frequently 
 
 
4 
Constantly 
 
5. Question about REMOVING YOUR LENSES: 
How often during the past week, did your eyes 
bother you so much that you felt as if you needed to 
stop whatever you were doing and take out your 
contact lenses?   
 
 
1 
Never (please skip to question 14) 
 
2 
Less than once a week 
 
3 
Weekly 
 
4 
Several times a week 
 
5 
Daily 
 
6 
Several times a day 
Patient/Subject  #:_____________ 
Date:__/___/____Time:________ 

 
Date:  
Study:  
Subject #: 
Visit #: 
 
Eye:     OD 
OS 
 
Other Specifications: __________________________________ 
 
 
Please rate on the scale below how comfortable your contact lenses feel at this moment. 
 
 
  
  
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Verification Initials: ______________ 
extremely  comfortable  
extremely  uncomfortable   

Subject #:  
 
 
Date: 
 
Visit #:  
 
Eye (circle):    OD    OS 
 
4M 
4M 
HI ILLUM/HC 
 
131 
1.0 
D 
S 
R 
K 
N 
 
104 
0.9 
C 
K 
Z 
O 
H 
 
83 
0.8 
O 
N 
R 
K 
D 
 
66 
0.7 
K 
Z 
V 
D 
C 
 
52 
0.6 
V 
S 
H 
Z 
O 
 
42 
0.5 
H 
D 
K 
C 
R 
 
33 
0.4 
C 
S 
R 
H 
N 
 
26 
0.3 
S 
V 
Z 
D 
K 
 
21 
0.2 
N 
C 
V 
O 
Z 
 
16.5 
0.1 
R 
H 
S 
D 
V 
 
13 
0.0 
S 
N 
R 
O 
H 
 
10.5 
-0.1 
O 
D 
H 
K 
R 
 
8 
-0.2 
Z 
K 
C 
S 
N 
 
6.5 
-0.3 
C 
R 
H 
D 
V 
 
  
   
 
 
 
 
 
 

 
 
Consent to Take Part in a Human Research Study 
 
Page 1 of 11 
 
 
 
Title of research study: An Evaluation of Tangible Boost Replenishing System on the 
Continued Efficacy of Tangible HydraPEG Rigid Gas Permeable Contact Lens Coating. 
Why am I being invited to take part in a research study? 
We invite you to take part in a research study because you are a corneal or scleral 
contact lens wearing member of the population. This research is funded by Tangible 
Science, LLC (previously known as Ocular Dynamics). 
What should I know about a research study? 
• Someone will explain this research study to you. 
• Whether or not you take part is up to you. 
• You can choose not to take part. 
• You can agree to take part and later change your mind. 
• Your decision will not be held against you. 
• You can ask all the questions you want before you decide, and can ask questions 
at any time during the study. 
Why is this research being done? 
This research project is being done to evaluate the effectiveness of a new solution that is 
designed to replenish the HydraPEG contact lens coating. HydraPEG is a soft and rigid 
contact lens coating, primarily composed of polyethylene glycol (a safe molecule 
commonly found in artificial tear solution), which is bound to the surface of a contact 
lens. The HydraPEG coating is intended to improve wettability and comfort with the 
lenses, and is currently FDA approved. However, the coating naturally diminishes from 
the surface of the lens over time (due to cleaning, and blinking over the surface of the 
contact lens). The Tangible Boost system is used to replenish the coating, and this is a 
study to evaluate its effectiveness. 
How long will the research last? 
We expect that you will be in this research study for approximately 5 months once you 
are enrolled, and there will be a minimum of 5 study visits over the 5-month period. 
Additional visits may be needed between visit 2 and 3, in order to make any necessary 
modifications to the way the lenses fit your eye.  

Consent to Take Part in a Human Research Study 
 
Page 2 of 11 
 
Visit 1 will last approximately 1 hour 40 minutes. 
The second visit will occur 2-3 weeks after the first visit, and it will last approximately 
45 minutes. The 3rd visit, which will be about 1 month after the 2nd visit, and will last 
about 85 minutes.  The 4th visit will be the day after the 3rd visit and will last 
approximately 25 minutes. The 5th visit will occur approximately 60 days after the 4th 
visit, and will last approximately 25 minutes.  
How many people will be studied?  
We expect to enroll about 40 people in this research study. 
What happens if I say yes, I want to be in this research? 
If you agree to take part in this study, you will first sign this consent form and the 
HIPAA privacy document before any study-related procedures are performed. You must 
be at least 18 years of age and be able and willing to follow study instructions. You will 
not be allowed to participate in the study if you are currently pregnant or nursing. Some 
exclusion criteria may apply, such as if you use ocular medications (except for artificial 
tears/rewetting drops), have any ocular infections or any ocular condition that may 
affect visual performance, have a history of any ocular surgery in the past 12 weeks, 
participated in another study recently, or had any systemic medication changes recently. 
Additionally, you must be a habitual rigid contact lens wearer to participate in this 
study. A study staff member will let you know if you are eligible to participate or not. If 
you qualify for the study, the following procedures that are in the table below will be 
performed during the associated study visits. These procedures do not involve treatment 
for any condition.  
If you agree to participate in the usability portion of the study (training), you will be 
recorded using the tangible boost solution so that the usability of the product can be 
evaluated. For this portion of the study (occurs during Visit 3), you will watch an 
instruction video, and then use the boost product on a pair of dummy lenses, after which 
you will answer some questions about your understanding of the product.  
The treatment you get will be chosen by chance, like flipping a coin. You will have an 
equal chance of being given each treatment. One of these treatments may contain no 
active treatment (such as standard saline solution), called a placebo. You will not be told 
which treatment you are getting; however your study doctor will know. 
 
Procedure 
Length of Time Required for 
Participants 
VISIT 1: Initial Evaluation 
 
Informed consent & HIPAA 
35 minutes 
General History and medications  
5 minutes 

Consent to Take Part in a Human Research Study 
 
Page 3 of 11 
 
Visual Acuity 
5 minutes 
Questionnaires (CLDEQ8 + VAS) 
10 minutes 
Keratograph Surface Evaluation 
5 minutes 
Slit-lamp Examination (with lenses on and after lens 
removal) 
10 minutes 
Contact lens fitting* 
30 minutes 
*The scleral or corneal lens that you are fitted with is a commercially available rigid lens manufactured 
by AVT technologies. The lenses will then be coated with the HydraPEG rigid lens coating for 
increased wettability. These will be the lenses that are dispensed to you at the second visit. 
TOTAL TIME 100 minutes 
 
 
VISIT 2: HydraPEG dispense 
Visual Acuity 
5 minutes 
Questionnaires (CLDEQ8 + VAS + supplemental VAS) 
10 minutes 
Keratograph Surface Evaluation 
5 minutes 
Slit-lamp Examination 
5 minutes 
Contact lens evaluation & dispense** 
20 minutes 
**Additional visits may be required to achieve an adequate corneal or scleral lens fit if the lenses are 
not acceptable. It is anticipated that the fitting process will take 1-3 visits total (including Visit 1 and 
2).  The only tasks done at any additional fitting visits will be to evaluate the fit of the lens and make 
any necessary changes. Follow-up fitting visits are expected to take 15 minutes – for a slit lamp 
evaluation of the lenses and necessary parameter changes to be determined. Since you are an 
established lens wearer, we do not anticipate a long fitting process. 
TOTAL TIME 45 minutes 
 
 
VISIT 3: Tangible Boost Dispense 
Visual Acuity 
5 minutes 
Questionnaires (CLDEQ8 + VAS + supplemental VAS) 
10 minutes 
Keratograph Surface Evaluation 
5 minutes 
Slit-lamp Examination 
5 minutes 
Tangible Boost or placebo dispense & training++ 
60 minutes 

Consent to Take Part in a Human Research Study 
 
Page 4 of 11 
 
++You will be dispensed either a Tangible Boost kit, or the placebo (which is Unique pH, a commonly 
used overnight storage solution for rigid lenses). These solutions will be stored in two single use vials 
that will be combined in the supplied case. You will be asked to store your lenses in the solution for 30 
minutes that night and then transfer them to Unique pH solution for the rest of the night, and return to 
the clinic the next day for evaluation wearing your lenses. If you agree, you will be audio and video 
recorded and photographed during the training session so that we can evaluate how user-friendly the 
product is. If you do not agree to be recorded during the training session, you will still be trained and 
can still participate in the study.  
This is a randomized study to evaluate the boost solution against a placebo control, so you will not 
know which of the systems you are being given, and they will not be recognizable from the packaging 
they are stored in. You will also be asked to use a second dose of the solution (to be given at visit 4) 30 
days after visit 4, and 30 days prior to visit 5. You will receive a phone call or email reminding you to 
use the solution at this mid-visit mark. 
TOTAL TIME 85 minutes 
 
 
VISIT 4: Tangible Boost Follow-Up #1 
Visual Acuity 
5 minutes 
Questionnaires (CLDEQ8 + VAS + supplemental VAS) 
10 minutes 
Keratograph Surface Evaluation 
5 minutes 
Slit-lamp Examination 
5 minutes 
TOTAL TIME 25 minutes 
 
 
VISIT 5: Tangible Boost Follow-Up #2 
Visual Acuity 
5 minutes 
Questionnaires (CLDEQ8 + VAS + supplemental VAS) 
10 minutes 
Keratograph Surface Evaluation 
5 minutes 
Slit-lamp Examination 
5 minutes 
TOTAL TIME 25 minutes 
  
 
This second table describes the procedures that are included above: 
Test 
Description 
General History and 
Medications 
Participants will be asked questions about their general, ocular 
and medication use histories along with contact lens use history 
if applicable.  
Questionnaires 
Subjects will be asked to fill out the following questionnaires: 
• Contact Lens Dry Eye Questionnaire - 8 (CLDEQ – 8) 
• Visual analog scale (VAS) 0-100 
• An additional VAS survey will be given to evaluate your 

Consent to Take Part in a Human Research Study 
 
Page 5 of 11 
 
satisfaction and experience with your customary lenses 
and the coated lenses.  
These questionnaires assess the level of eye and/or contact lens 
discomfort.  
Scleral / corneal lens 
fitting 
The examiner will fit you with scleral or corneal contact lenses 
using commercially available lens fitting sets.  (from AVT 
Technologies, CO). Contact lenses will be fit using the 
customary fitting procedure, where a lens from a fitting set is 
applied to the eye, the power needed for you is determined, and 
then customized lenses are ordered with the over-refraction 
incorporated and any fitting parameters are altered based on the 
investigators’ expertise.  
Scleral / corneal Lens 
Evaluation 
The ordered lenses will be applied to your eye by the 
investigator, after which the fit and vision will be evaluated. At 
this time, if the fit of the lens is adequate, the lenses will be 
dispensed. If there are additional parameter changes needed, 
they will be ordered at this time.  
Visual Acuity 
Your vision in each eye will be measured with a high contrast 
visual acuity chart. You will be asked to cover one eye and read 
the chart, and this procedure will be repeated for your other eye.   
Slit-lamp 
Examination 
The front portion of your eye and contact lenses will be 
examined with a lighted microscope. You will be asked to place 
your chin on the chinrest and place your forehead against the bar 
and look straight ahead. The instruments light will be shined 
onto your eye to visualize the ocular surface for approximately 
2-3 minutes per eye.   
Oculus Keratograph  
The OCULUS Keratograph® 5M is an advanced, non-invasive 
imaging system that will be used to image the surface of your 
contact lenses while they are on your eye. These measurements 
will allow us to evaluate the wettability of the front surface of 
the lens.  
Lissamine GreenGlo 
Strips 
Individual paper strips with 1.5mg of Lissamine Green (a commonly 
used diagnostic dye for the ocular surface) will be used to put a small 
amount of green dye on the surface of your eyes. The dye is attracted 
to dead cells and irregularities at the ocular surface. These strips are 
commonly used in practice as a gold standard for evaluating 
compromise to the cells on the front surface of your eye. 

Consent to Take Part in a Human Research Study 
 
Page 6 of 11 
 
Tangible Boost Training 
For this portion of the study (occurs during Visit 3), you will 
begin by watching a 5-minute introduction video about the 
product and study. You will be presented the Tangible Boost in 
its packaging which will include material to help you use the 
product. We will give you some time to familiarize yourself 
with the materials provided. Once you feel ready to use the 
product, we will ask you perform a Boost Treatment using the 
product and other use scenarios with the product, which will 
take about 60 minutes. 
 
Observations, Video Taping, and Use of Data 
This research study includes the following component(s) where we plan to audio 
record/video record/photograph you as the research subject: 
We will record audio and videotape your interaction with the tangible boost 
replenishing system. In additional still photos may be obtained. We will be observing 
you and collecting data while you use the product. In addition, we will test certain 
features and assess the clarity of the instructions and information. You will be asked 
questions regarding your experience and opinions. By signing this informed consent 
form, you authorize University of Houston, Tangible Boost and UserWise to take photo 
and audio/video footage of yourself, your comments, and your interactions with the 
product. Videos will be used within the companies to make improvements to the 
Tangible Science product (product development and user experience). These photos and 
videos may be shared with regulatory agencies; you will be identifiable due to the fact 
that the company uses facial expressions to evaluate some of the usability characteristics 
of the product; however, your record will not contain your last name or a medical record 
number. 
If you do not agree to be videotaped and participate in the usability portion of the 
study, you will still be able to participate in the study.  
 
 I agree to be [audio recorded/video recorded/photographed] during the research 
study. 
 I agree that the [audio recording/video recording)/photographs] can be used 
in publication/presentations. 

Consent to Take Part in a Human Research Study 
 
Page 7 of 11 
 
 I do not agree that the [audio recording/video recording)/photographs] can 
be used in publication/presentations. 
 I do not agree to be [audio recorded/video recorded/photographed] during the 
research study.  
 
What are my responsibilities if I take part in this research? 
If you take part in this research, you will be responsible for the following, outside of the 
study visits: 
- Applying, remove and cleaning the rigid lenses that you are given in this study, 
on a daily basis for the study period in which you will be wearing them. 
- Storing the lenses in either the Tangible boost solution or the placebo storage 
solution for 30 minutes at Day 30 and 60 after lens dispense.   
What happens if I do not want to be in this research? 
You can choose not to take part in the research and it will not be held against you. 
Choosing not to take part will involve no penalty or loss of benefit to which you are 
otherwise entitled. 
If you are a student, a decision to take part or not, or to withdraw from the research will 
have no effect on your grades or standing with the University of Houston. If you are 
receiving clinical care, a decision to take part or not will have no effect on what would 
be offered to you as part of routine care. 
The alternative to this study is continuing wear with your habitual rigid lenses and not 
receiving the coating or the boost solution.  
The important risks and possible benefits of these alternatives include: Possible risks 
and adverse events are outlined in the section on how this study could be bad for you 
(two sections below). Possible benefits include experiencing improved comfort during 
the study while wearing the coated lenses; the coating is available in the US if you 
chose to have your habitual lenses coated if you like the comfort. 
What happens if I say yes, but I change my mind later? 
You can leave the research at any time it will not be held against you. 
If you decide to leave the research, there are no adverse consequences. If you decide to 
leave the research, contact the investigator so that the investigator can follow the proper 
protocol for exiting a study, and address any concerns or adverse events that you may be 
having as a result of being in the study (if this is applicable). You have no obligation to 
inform the investigator of your reasoning for leaving the study, and will not be 
penalized for exiting the study. However, you will only receive compensation for the 
study visits that you attend.  

Consent to Take Part in a Human Research Study 
 
Page 8 of 11 
 
If you stop being in the research, already collected data may not be removed from the 
study database.  
Is there any way being in this study could be bad for me? 
There are no foreseeable risks related to the procedures conducted as part of this study. 
There are risks in general that are associated with wearing any type of contact lens. 
These risks include developing an abrasion (‘cut’ on the eye) during lens application or 
removal, the accumulation of debris on or beneath the lenses, ocular stinging redness, 
itching, or irritation. All contact lens wearers are at risk for developing inflammatory 
and/or infectious complications during lens wear, but there is no added risk by 
participating in this study. If you participate in the userwise recorded usability portion 
of this study, you will not be using the product on yourself during the training session so 
there is no risk of harm to your lenses from the cleaning products. There is a risk of 
losing confidentiality/privacy to the employees at UserWise, since they will be viewing 
the recorded data from the training. The company employees only view the recordings 
on a need-to-know basis. In the unlikely event of a negative event in this study, please 
call the study coordinator (Sonia Huerta) or Dr. Maria Walker (contact info at the end of 
this document), and they will decide if you need to be seen by a professional.  If you 
experience an event such as an abrasion during a study visit, or as a result of wearing 
the rigid lenses, the condition will be treated as it is customarily, and the fees associated 
with treatment will be covered by the study. Any necessary and appropriate referrals 
will be offered by Dr. Maria Walker. If you experience an injury or negative event that 
is not related to the use of the rigid lens, you will be responsible for any medical 
treatments through your own medical insurance or as an out-of-pocket expense.  
Will I get anything for being in this study? 
You will receive a $20 Amazon.com gift card as compensation for your time at each study visit, 
for a total compensation of $100 if all five study visits are attended. If you come in for a study 
visit but are ultimately unable to complete the visit after it has begun, you will still be 
compensated with a $20 gift card. There will be no additional gift cards or compensation given if 
you need to come in for the potential addition fitting visits that may be required if there is a need 
for additional modifications of the lens to achieve adequate fit and vision.  
There is no additional compensation for participating in the training session (usability study), 
beyond what you would receive as compensation for participating in a study visit. 
Will being in this study help me in any way? 
 We cannot promise any benefits to you or others from your taking part in this research. 
However, possible benefits include experiencing improved comfort during the study 
while wearing the coated lenses; the coating is available in the US if you chose to have 
your habitual lenses coated after the completion of the study.  

Consent to Take Part in a Human Research Study 
 
Page 9 of 11 
 
What happens to the information collected for the research? 
Efforts will be made to limit the use and disclosure of your personal information, 
including research study and medical records, to people who have a need to review this 
information. Each subject’s name will be paired with a code number, which will appear 
on all written study materials. The list pairing the subject’s name to the assigned code 
number will be kept separate from these materials. We cannot promise complete 
secrecy. Organizations that may inspect and copy your information include the 
Institutional Review Board (IRB – the organization responsible for overseeing research 
involving human subjects, in regards to the safety of the subject) and other 
representatives of this organization, as well as collaborating institutions and federal 
agencies that oversee human subjects research. In addition, the Food and Drug 
Administration (FDA) may inspect the records of this study at any time. This research 
uses or discloses Protected Health Information as defined by the Health Insurance 
Portability and Accountability Act (HIPAA), and you will be asked to sign an additional 
document to authorize the use of this information.  
The video and audio information, as well as the questions asked regarding the use of the 
Tangible Boost system, will be securely sent to UserWise for analysis. Userwise may 
keep the recording indefinitely and may use the data for other medical research, but only 
research involving the product and subsequent products by the study sponsor.  
We may publish the results of this research. However, unless otherwise detailed in this 
document, we will keep your name and other identifying information confidential.  
If the sponsor pays any of your medical expenses, we may be required to give the 
sponsor (Tangible Science, Inc) your name, date of birth, and Medicare ID or social 
security number. 
Can I be removed from the research without my OK? 
The person in charge of the research study can remove you from the research study 
without your approval. Possible reasons for removal include if you are unable to 
complete the tasks in the study protocol. In addition, if you experience an adverse event 
in which the investigator does not feel that you should continue wearing the scleral 
lenses. We will tell you about any new information that may affect your health, welfare, 
or choice to stay in the research. 
Who can I talk to? 
If you have questions, concerns, or complaints, or think the research has hurt you, you 
should talk to the research team via Maria K. Walker, mkwalker@central.uh.edu, 713-
743-6241, or contact the study coordinator, Sonia Huerta @ 713-743-2736. 

Consent to Take Part in a Human Research Study 
 
Page 10 of 11 
 
This research has been reviewed and approved by the University of Houston 
Institutional Review Board (IRB). You may also talk to them at (713) 743-9204 or 
cphs@central.uh.edu if: 
• Your questions, concerns, or complaints are not being answered by the research 
team. 
• You cannot reach the research team. 
• You want to talk to someone besides the research team. 
• You have questions about your rights as a research subject. 
• You want to get information or provide input about this research. 
 

Consent to Take Part in a Human Research Study 
 
Page 11 of 11 
 
Signature Block for Capable Adult 
 
Your signature documents your consent to take part in this research. 
 
 
 
Signature of subject 
 
Date 
 
 
Printed name of subject 
 
 
 
Signature of person obtaining consent 
 
Date 
 
 
 
Printed name of person obtaining consent 
 
 
 
 
In the future, our research team may be interested in contacting you for other research 
studies we undertake, or to conduct a follow-up study to this one. There is never any 
obligation to take part in additional research. Do we have permission to contact you to 
provide additional information? 
 
 Yes 
 No 
 

Page 1 of 2 
 
 
 
 
 
Authorization for Use and Disclosure  
of Protected Health Information for Research Purposes 
 
 
State and federal medical privacy laws protect the use and release of your personally identifiable health 
information (“Protected Health Information”). By signing this document, you authorize the Principal 
Investigator and research team to access, use and/or release your Protected Health Information for the 
following research study: 
 
Title of Research Protocol:  An Evaluation of Tangible Boost Replenishing System on the 
Continued Efficacy of Tangible HydraPEG Rigid Gas Permeable Contact Lens 
Coating.Name of Principal Investigator: Maria K. Walker, OD, MS 
 
This research study is described in full in the associated informed consent document.  
 
The health information that we may use or disclose for this research includes your research record and your 
complete health care records. This may include, for example, medical history, results of examinations, 
treatment and outcomes, results of lab tests, or other information contained within your health, billing and/or 
other records at the:  
• University Eye Institute 
• The Ocular Surface Institute 
 
Special permission is required to release drug, alcohol, and substance abuse records, HIV/AIDS-related 
information, genetic information and mental health information. These kinds of records will not be used or 
disclosed in this study unless a separate section is included below and you specifically allow us to do so by 
initialing the applicable box(es).  
 
In addition to the UH research team, your Protected Health Information may be used by and/or disclosed to: 
 
• 
Members and staff of the UH Institutional Review Board (IRB) 
• 
Others with oversight of the study or who are required by law to review the quality and safety of the 
research, such as the U.S. Food and Drug Administration and/or the Health and Human Services Office 
of Human Research Protections.  
 
In addition to the purpose of the research described in the consent form, your Protected Health Information 
may be used to:  
• 
Improve the design of future studies; 
• 
Share with business partners of the sponsor;  
• 
File applications with U.S. or foreign government agencies to get approval for new drugs or health 
care products; or  
• 
As authorized by federal/state medical privacy laws or as otherwise required or authorized by federal 

Page 2 of 2 
 
 
 
or state law. 
Please note that: 
• 
The research team will use and protect your information as described in this Authorization; however, 
once your health information is released by the University of Houston, it may not be protected by the 
privacy laws and might be shared with others.  A member of the research team will be happy to 
respond to any of your questions regarding this.   
• Signing this authorization is voluntary.  You are not required to agree to the use or disclosure of your 
Protected Health Information. Signing this authorization is not a condition for treatment (other than 
treatment related to this research study), payment, or enrollment or eligibility for health plan benefits. 
However, if you do not sign the document, you cannot participate in this research study and you may 
not receive research-related treatment. 
• The University of Houston will not condition routine clinical treatment, payment, or enrollment of 
eligibility for benefits based on whether or not you sign this Authorization. 
• You may change your mind and revoke (take back) this Authorization at any time.  Before doing so, you 
may want to ask someone on the research team if canceling will affect your research-related medical 
treatment.   If you cancel your permission, you may no longer participate in the research study.   Also, if 
you cancel, your Protected Health Information that has already been collected, used, and/or disclosed in 
reliance upon this authorization may continue to be used, and to the extent it has already been disclosed 
may be subject to redisclosure. In addition, the sponsor and government agencies may continue to look 
at your medical records to review the quality or safety of the study to the extent authorized/required by 
law.  
       I agree to allow my information to be disclosed for the additional optional research activities explained in 
the informed consent process.  
 
This Authorization does not have an expiration date. If you revoke this Authorization, you may no longer be 
allowed to participate in the research described in this Authorization.  
 
To revoke this authorization, please contact the research team to tell them of this decision.  They will give you 
an address so that you can inform the investigator in writing.   
 
You must also notify the Director of the UH Office of Research Policies, Compliance, and Committees to revoke 
the authorization.  
Director, Office of Research Policies, Compliance, and Committees 
University of Houston Division of Research 
4302 University Drive, Suite 316 
Houston, TX 77204-2015 
Signing this form indicates that you have read and/or understand the information in this form, that your 
questions have been answered to your satisfaction, and that you voluntarily agree to participate in this 
research study.  You will receive a copy of this signed authorization. 
 
 
 
Signature of Participant  
(or Participant’s Personal Representative) 
Date 
 
Printed Name of Participant  
(or Participant’s Personal Representative) 
If applicable, a description of the Personal 
Representative’s authority to sign for the 
Participant