Toric Contact Lens Performance Study
Phase: NA
Conditions: Astigmatism
Sponsor: University of Houston

Title: Toric Contact Lens Performance Study  
 
NCT number: NCT03546647 
 
Document date: 
Protocol: 27 Aug 2018 
Consent: 16 Apr 2018 

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PRINCIPAL INVESTIGATORS:
Kathryn Richdale, OD, PhD
Associate Professor
University of Houston College of Optometry
Richdale@central.uh.edu
713-743-1974
Eric Ritchey, OD, PhD 
Assistant Professor 
University of Houston College of Optometry 
ERRitche@central.UH.edu  
713-743-1933 
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Table of Contents
1.0
Objectives .............................................................................................................................3
2.0
Background...........................................................................................................................3
3.0
Inclusion and Exclusion Criteria ..........................................................................................3
4.0
Number of Subjects ..............................................................................................................4
5.0
Recruitment Methods............................................................................................................5
6.0
Study Endpoints....................................................................................................................6
7.0
Procedures Involved .............................................................................................................6
8.0
Setting.................................................................................................................................11
9.0
Drugs or Devices ................................................................................................................11
10.0
Risks to Subjects.................................................................................................................11
11.0
Potential Benefits to Subjects .............................................................................................12
12.0
Withdrawal of Subjects.......................................................................................................12
13.0
Costs/Payments to Subjects ................................................................................................13
14.0
Compensation for Research-Related Injury........................................................................13
15.0
Confidentiality ....................................................................................................................13
16.0
Provisions to Protect the Privacy Interests of Subjects. .....................................................13
17.0
Informed Consent Process ..................................................................................................13
18.0
HIPAA ................................................................................................................................14
20.0 Data Management..................................................................................................................14
21.0 Specimen Use and Banking...................................................................................................14
22.0 Sharing of Results with Subjects ...........................................................................................14
23.0 Resources...............................................................................................................................14
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1.0
Objectives
This study seeks to quantify the near visual performance and subjective visual acceptance 
of toric contact lenses as compared to spherical lenses in an astigmatic cohort of patients.
Study Hypotheses: Subjects will have better near visual acuity and near visual 
performance with toric, as opposed to spherical, contact lens correction. As such, the 
following hypotheses will be tested:

H01: There is no statistically significant difference in near visual acuity or near 
vision performance between contact lenses corrections

Ha1: There is a statistically significant difference in visual acuity or vision 
performance between contact lenses corrections
2.0
Background
Americans spend over 10 hours a day consuming media on smartphones, digital tablets and 
home computers.1 The visual demands of this type of work require the use of sustained 
clear near and intermediate vision. Previous work in our labs has shown small but 
measureable improvements in visual acuity for multifocal contact lenses as compared to 
monovision2, 3 and toric lenses4 as compared to spherical correction; especially in low 
lighting or low contrast conditions. Unfortunately standard in office high contrast, high 
luminance testing is often not helpful in demonstrating potential improvement in real-world 
tasks afforded by toric lenses.
Woods et al began exploring patients’ preferences conducting real-world tasks such as the 
ability to locate a web page, read a newspaper or use a computer.5 They showed that while 
the difference in standard acuity testing were small, patients reported significant subjective 
improvements in driving, watching a television, and using a desktop computer, among 
others.5 
Wolffsohn and colleagues recently developed iPad based applications that can quantify 
reading performance on digital devices while the user performs reading tasks (see also 
Appendix).6 The user’s face is analyzed in real-time by the front facing camera to allow 
working distance and blinks to be tracked. Swipes, changes in magnification and the time 
to complete the task are also assessed. This group also developed a Near Activity Visual 
Questionnaire (NAVQ) to quantify subjective near visual function.7  
  
The purpose of the proposed study it to quantify subjective and objective benefits of toric 
corrections in astigmatic patients, , using the latest digital and patient reported outcomes 
tools. 
3.0
Inclusion and Exclusion Criteria
ALL SUBJECTS

Able to read and understand the study informed consent
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
+0.50 to +4.00 or -0.50 to -6.00 D  vertex corrected sphere power 

Best corrected acuity of 20/25 or better in each eye

Self report of at least 5 hrs/day using digital devices

No history of ocular pathology or surgery

No active ocular infection or clinically significant ocular inflammation

No significant binocular vision abnormality

No gas permeable lens wear for at least 3 months

Not an optometrist or optometry student

Not pregnant/lactating (by self-report)

18 to 39 years of age (inclusive)

0.75 to 1.50 D vertexed refractive cylinder OD and OS
Potential subjects will be initially screened for study eligibility by phone/in person 
discussion and through collection of baseline data at visit 1. 
Vulnerable Populations
The following vulnerable populations will be excluded from the study:
1. Adults unable to consent
2. Individuals who are not yet adults (infants, children, teenagers under age 18)
3. Prisoners 
4.   Students for whom the principal investigators have direct access to/influence on 
grades. 
5.   Pregnant/lactating women (by self-report)
4.0
Number of Subjects
The proposed single-site study will be conducted at The Ocular Surface Institute at the 
University of Houston College of Optometry. Up to 76 subjects will be screened for 
study inclusion, with the goal of completing 34 subjects. 
Source data will be collected on paper case report forms and then doubly entered 
electronically into a database by trained personnel.  Source data will be quality assured 
at the levels of coding, scoring, and entry prior to locking the dataset for analysis.
In this within-subject crossover design, a paired t-test will be used to compare primary 
outcome visual acuity performance of study treatment lens wear to standard spherical 
contact lens wear among astigmats.  We will use a two-sided independent t-test to 
ensure there are no carry over or period effects in our cross-over design, although it is 
not anticipated.  As a secondary outcome, subjects will be asked their preference of 
contact lenses in a two-alternative forced choice format.  A one-sample binomial test 
will be used to test the hypothesis that the probability of preference to treatment lens and 
standard lenses are equally likely (H_0: p=.5 v.H_1: p≠.5).  
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We aim to test the hypothesis that H_0: ∆=0 v.H_1: ∆≠0 using a two-sided test with 
significance level α=0.05, where ∆ is the underlying benefit for treatment contact lenses 
versus spherical contact lenses in this cross-over design.  Based on previous studies 
reported average photopic low contrast visual acuity ranged from 0.3 to 0.4 logMAR 
with various brands of toric contact lenses and under the same conditions from 0.51 to 
0.56 with spherical contact lenses among low-to-moderate astigmatic eyes.  An 
estimated improvement with toric lenses has been reported as 0.07±-0.14 among those 
with low astigmatism with the magnitude of improvement increasing among those with 
high levels of astigmatism.  It is reasonable to expect a detectable range of 2 letters to 
half-line of improvement with the treatment contact lenses versus the standard sphere 
lenses.  If we expect a half-line treatment benefit and the within-subject variance of the 
difference in mean visual acuity between the two periods to be a line (0.1 logMar), then 
based on pilot-study results, and a required 80% power we need 34 participants overall 
for each study population (68 total).  We will randomize an equal number of subjects to 
each group (i.e., group A receives treatment 1 in period 1 and treatment 2 in period 2; 
group B receives treatment 2 in period 1 and treatment 1 in period 2). Depending on the 
variability, a sample size of 34 in each sampled population allows us to detect a smaller 
effect size (e.g., high contrast tests) as low as 2.5 letters with a within-subject variability 
of 0.06 logMar. The visual function testing is novel and has not been used on a 
population of astigmatic contact lens wearers. So sample size planning cannot be done 
for these tests. We plan to screen up to 38 participants from the study population to 
allow for attrition.  
5.0
Recruitment Methods
Potential subjects will be recruited from the patients and staff of the University Eye 
Institute/University of Houston College of Optometry, as well as the surrounding 
community via verbal communication, print media (e.g. study fliers, newspaper 
adverts), telephone and electronic media (e.g. email, The Ocular Surface Institute 
Website, social media). Additionally, potential subjects will be identified and recruited 
via The Ocular Surface Institute’s research database. 
The total duration of an individual subject's participation in the study will be less than 1 
month. The study will consist of 5 visits. Visit 1 will be a baseline evaluation, pre-
fitting assessment, randomization, and contact lens fitting. Visits 2 and 4 will be contact 
lens follow-ups. Visits 3 and 5 are outcome visits. Expected visit timing is summarized 
in the table below:
Anticipated Visit Timing and Duration
Study Window
Study Visit
Duration
Day 1
Visit 1: Baseline, randomization, contact lens 
fitting 
120 minutes
Day 4 ± 2
Visit 2: Contact lens follow-up
30-50 minutes
Day 10 ± 2
Visit 3: Outcome lens #1, re-fit to lens #2
75 minutes
Day 13 ± 2
Visit 4: Contact lens follow-up
30-50 minutes
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Day 20 ± 2
Visit 5: Outcome lens #2 
55 minutes
The anticipated duration to enroll and complete all study subjects is approximately 6 
months. The estimated date for the investigators to complete analyses for this study is 
August 2018.
6.0
Study Endpoints
The primary study endpoints will compare toric to spherical lenses for:

Binocular near visual acuity
The secondary study endpoints will compare toric to spherical lenses for:

Binocular near visual performance
o
Reading speed, errors, etc.

Contrast
o
Binocular low contrast acuity, contrast sensitivity at near
7.0
Procedures Involved
The study is a clinical trial. Subjects will be randomized to start with either toric lenses or 
spherical correction. Patients will be seen for 5 visits over a period of approximately 1 
month. Visit l will determine subject eligibility for the study. Visits 2 and 4 are contact 
lens follow-up visits. Visits 3 and 5 are study outcome visits. Tests of visual performance 
at a near reading distance will be evaluated with an iPad application (Optom Central) 
developed by Dr. James Wolffsohn. This application can measure reading speed, near 
contract sensitivity and can provide information on how a subject interacts with the 
electronic device (e.g. blink rate, working distance from the device, scrolling and 
zooming on the page, etc.).  This application is designed for research purposed only and 
is not commercially available in the Apple App Store. 
Visit 1: Screening, Enrollment and Baseline
Step
Item
Details
1.1.1
Informed Consent
Review and complete the informed 
consent form
1.1.2
Subject Demographics
Collect subject demographic data
1.1.3
Medical/Ocular History
Collect subject history including 
contact lens history
1.1.4
Concomitant Medications
Collect information on concomitant 
medications
1.1.5
Distance and Near Visual Acuity
Perform Distance and Near Snellen 
and LogMAR acuity OD/OS with the 
patient’s habitual correction. 
1.1.6
Questionnaires
Administer the NAVQ to the subject
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1.1.7
Contrast Sensitivity 
Perform the contrast sensitivity test on 
the iPad
1.1.8
Radner reading test
Perform the Radner reading speed test 
on the iPad
1.19
Functional Vision testing with iPad
Perform the functional vision test on 
the iPad
1.1.10
Auto-Refraction / Auto-keratometry
Perform autorefraction/keratometry 
with open field machine
1.1.11
Refraction
Perform Manifest Refraction using 
maximum plus to best visual acuity
1.1.12
Accommodation, binocular vision 
Conduct negative relative 
accommodation and positive relative 
accommodation test, Modified 
Thorington Test at distance and near
1.1.13
Pupil size
Measure pupil size OD/OS in dim and 
bright light settings
1.1.14
Slit Lamp Exam with NaFl staining
Instill 1 drop of NaFL and evaluate slit 
lamp findings using the CCLRU 
grading scale 
1.1.15
Check of eligibility and lens order 
randomization 
Confirm eligibility criteria are met.
If so, use randomization table to 
determine order of lens wear
1.1.16
Contact Lens Fitting
Fit subject in the first set of contact 
lenses based on randomization 
schedule. 

The toric lens parameters 
should be selected based on the 
manufactures fitting guide. 

The powers for the spherical 
lenses should be the vertexed 
spherical equivalent.
After allowing the lens to settle for 10 
minutes, assess the fit using slit lamp 
biomicroscopy.
1.1.17
Contact Lens Over-Refraction
Perform over-refraction using 
maximum plus to best visual acuity

Perform best sphere and 
sphero-cylindrical over-
refraction
1.1.18
Contact Lens Power Adjustment (if 
necessary)
Follow the manufactures fitting guide 
and modify contact lens power, based 
upon the Contact Lens Over-
Refraction, if the subject gains more 
than 3 letters of acuity with over-
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refraction 
Visit 2: Contact Lens Follow Up Lens #1
Note: Subjects should report wearing their assigned study contact lenses at least 2 hours. 
2.1
Visual Acuity
Perform Distance Snellen acuity OD/OS 
with the patient’s study lens correction. 
2.2
Contact Lens Assessment
Assess the fit using slit lamp 
biomicroscopy.
2.3
Contact Lens Over-Refraction
Perform over-refraction using maximum 
plus to best visual acuity
2.4
Contact Lens Power Adjustment (if 
necessary)
Follow the manufactures fitting guide 
and modify contact lens power, based 
upon the Contact Lens Over-Refraction, 
if the subject gains more than 3 letters of 
acuity with over-refraction

Perform best sphere and sphero-
cylindrical over-refraction
2.5
Slit Lamp Exam with NaFl 
Remove the contact lens and instill NaFL 
then evaluate slit lamp findings using the 
CCLRU grading scale 
Visit 3: Outcome Lens #1
Note: Subjects should report wearing their assigned study contact lenses at least 2 hours.
3.1
Visual Acuity
Perform Distance Snellen acuity OD/OS 
with the patient’s study lens correction. 
3.2
Questionnaires
Administer the NAVQ to the subject
3.3
High and Low Contrast Near Visual 
Acuity 
Measure logMAR high and low contrast 
acuity at near OU with high luminance
3.4
Contrast Sensitivity 
Perform the contrast sensitivity test on 
the iPad
3.5
Radner reading test
Perform the Radner reading speed test on 
the iPad
3.6
Functional Vision testing with iPad
Perform the functional vision test on the 
iPad
3.7
Slit Lamp Exam with NaFl 
Remove the contact lens and instill NaFL 
then evaluate slit lamp findings using the 
CCLRU grading scale
3.8
Contact Lens Fitting
Fit subject in the second set of contact 
lenses based on randomization schedule. 

The toric lens should be selected 
based on the manufactures fitting 
guide. 

The powers for the spherical 
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lenses should be the vertexed 
spherical equivalent.

After allowing the lens to settle 
for 10 minutes, assess the fit 
using slit lamp biomicroscopy.
3.9
Contact Lens Over-Refraction
Perform over-refraction using maximum 
plus to best visual acuity
3.10
Contact Lens Power Adjustment (if 
necessary)
Follow the manufactures fitting guide 
and modify contact lens power, based 
upon the Contact Lens Over-Refraction, 
if the subject gains more than 3 letters of 
acuity with over-refraction
Visit 4: Contact Lens Follow Up Lens #2
Note: Subjects should report wearing their assigned study contact lenses at least 2 hours.
4.1
Visual Acuity
Perform Distance Snellen acuity OD/OS 
with the patient’s study lens correction. 
4.2
Contact Lens Assessment
Assess the fit using slit lamp 
biomicroscopy.
4.3
Contact Lens Over-Refraction
Perform over-refraction using maximum 
plus to best visual acuity
4.4
Contact Lens Power Adjustment (if 
necessary)
Modify contact lens power, based upon 
the Contact Lens Over-Refraction, if the 
subject gains more than 3 letters of acuity 
4.5
Slit Lamp Exam with NaFl 
Remove the contact lens and instill NaFL 
then evaluate slit lamp findings using the 
CCLRU grading scale 
Visit 5: Outcome Lens #2
Note: Subjects should report wearing their assigned study contact lenses at least 2 hours.
5.1
Visual Acuity
Perform Distance Snellen acuity OD/OS 
with the patient’s study lens correction. 
5.2
Questionnaires
Administer the NAVQ to the subject
5.3
High and Low Contrast Near Visual 
Acuity 
Measure logMAR high and low contrast 
acuity at near OU with high luminance
5.4
Contrast Sensitivity 
Perform the contrast sensitivity test on 
the iPad
5.5
Radner reading test
Perform the Radner reading speed test on 
the iPad
5.6
Functional Vision testing with iPad
Perform the functional vision test on the 
iPad
5.7
Slit Lamp Exam with NaFl 
Remove the contact lens and instill NaFL 
then evaluate slit lamp findings using the 
CCLRU grading scale
5.8
Study Exit
Ensure all paperwork is complete and 
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exit the subject from the study. 
8.0
Setting
Layman’s Description of Procedures
Patient demographics
The subjects will be asked questions about their age, 
sex, race and ethnicity.
History
The subjects will be asked questions about their 
systemic and eye health and surgical history. The 
subjects will be asked questions about how they use 
their current contact lenses, such as their current contact 
lens brand and wear time, as performed during a normal 
eye exam.
Concomitant Medications
The subjects will be asked questions about their current 
ocular and systemic medications.
Visual acuity and contrast 
sensitivity
Measurements of how well subjects can detect 
letters/lines and with varying levels of contrast (black 
versus grey on light background)
Auto-refraction/keratometry
A machine will shine light into a subject's eye and will 
estimate their prescription and curvature of the eye 
without making contact with the eye.
Slit Lamp Exam
A specialized microscope is used to shine light on the 
eye and to examine the health of the front of the eye. 
Sodium fluorescein (NaFl) is a temporary dye that is 
used in routine contact lens exams to evaluate the health 
of the front surface cells.
Refraction
The subject’s prescription is determined by placing 
different power lenses in front of the subject’s eye, and 
modified according to the subject’s responses. 
Contact Lens Fitting
A contact lens is placed on the eye and the fit is 
assessed (how much is moves, where it sits on the eye, 
etc.). This is done using a slit lamp biomicroscope. 
Contact Lens Over-Refraction 
and Power Adjustment
Lenses will be placed in front of the subject’s eye while 
wearing the study contact lenses to determine if the 
prescription needs to be changed according to the 
subject’s responses. The contact lens power will be 
adjusted if needed based on standard clinical fitting 
guidelines.
Questionnaires 
Asks the subject about his/her vision 
Radner Reading and 
functional vision tests
Measure reading performance (speed, accuracy, etc.) 
using an iPad based app.
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All study visits will be conducted at the University of Houston College of Optometry in 
The Ocular Surface Institute (TOSI). 
9.0
Drugs or Devices  
No investigational drugs or devices will be used in this study. The contact lenses fit in the 
study are commercially available, FDA approved contact lenses that will be worn on a 
daily wear, daily disposable basis. An assistant will mask (over-label) contact lenses so 
that the subject and outcome examiner remain masked. The primary examiner will follow 
the manufacturer's fitting guide to determine the initial lens powers. Lens powers will be 
modified, as needed for best vision, according to the manufactures fitting guide. 
The ophthalmic dye used in the trial to evaluate the health of the front surface (sodium 
fluorescein) is a commercially available ocular diagnostic agent commonly used in 
routine clinical assessment of contact lenses in optometry. 
Study Arm
Study Contact Lenses (Alcon)
Base Curve Diameter
Dailies Aqua Comfort Plus Toric
8.8
14.4
Toric/Astigmatic
Dailies Aqua Comfort Plus Sphere
8.7
14.0
10.0
Risks to Subjects
The risks to the subjects in the trial are the same risks found in standard clinical practice 
and patients wearing contact lenses outside of a controlled trial. During study procedures, 
there is the risk of mild discomfort due to light being shined on the eye or through the use 
of topical ophthalmic diagnostic agents (sodium fluorescein) or insertion of contact 
lenses. Potential discomfort from these procedures is transient and self-limiting. 
Contact lenses will be fit as part of this study. The US Food and Drug Administration 
consider daily wear contact lenses Class II medical devices. While most individuals wear 
contact lenses without problems, there are some risks associated with wearing contact 
lenses. Ulcerative keratitis (infection of the clear front part of the eye), is the most severe 
risk and can lead to loss of vision. Ulcerative keratitis is estimated to happen to about 1-2 
out of 10,000 people who use daily wear, daily disposable contact lenses. The risk for 
ulcerative keratitis in this study is no different than the risk found with contact lens fitting 
in standard clinical practice. The risk of ulcerative keratitis may be reduced by educating 
subjects to carefully following the study doctor’s directions for lens care,  including 
throwing out your contact lenses each night, never sleeping or napping in contact lenses, 
and never exposing the contact lenses to water. These study instructions are the same as 
those provided to subjects in clinical practice
In addition to ulcerative keratitis, the following problems may occur when wearing 
contact lenses:
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
Other, less serious, infections or inflammation of the eye(s)

Burning, stinging, itching, dryness or general irritation of the eye(s)

Corneal neovascularization (small blood vessels growing into the cornea) 

Excessive watering, unusual eye secretions, or redness of the eye

Reduced or blurred vision (compared to glasses)

Seeing rainbows or halos around bright lights (compared to glasses)
Many of the potential problems associated with contact lens wear are self-limiting and 
can be resolved with discontinuation of lens wear. These problems can be minimized or 
avoided with proper contact lens fitting and follow-up. Subjects in the study will be 
examined approximately 3-7 days after contact lens fitting, which is a typical follow-up 
schedule seen in clinical practice for contact lenses worn in a daily wear modality.
Subject safety will be monitored in the trial through slit lamp evaluation of the ocular 
surface. Subjects will be educated to potential risk with contact lens wear and instructed 
to discontinue contact lens wear and contact the study investigators immediately if they 
experience any eye discomfort, excessive tearing, vision changes, redness of the eye, or 
other problems.
Subjects will be instructed that in the event they experience signs or symptoms associated 
with a potential adverse event, they should contact the study personnel immediately for 
evaluation.
11.0
Potential Benefits to Subjects
While there are few direct benefit to the study subjects, subjects will be unmasked (told 
what each of their study lenses were) at the end of the study. Through this they may learn 
more about their vision and visual performance with different types of contact lenses. 
Participation in the study may also improve the fitting of multifocal and toric contact 
lenses for future patients. 
12.0
Withdrawal of Subjects
Subjects may withdraw consent to participate in the study at any time. Subjects 
may be withdrawn from the trial by the study investigators if they fail to return for 
study visits or follow study instructions, have unacceptable vision or fit with the 
contact lenses, become pregnant during the trial, or have a study-related adverse 
event that warrants study withdrawal. 
13.0
Costs/Payments to Subjects
There are no expected additional costs to subjects that participate in the study. There is no 
cost to subjects for contact lens fitting in this study. Subjects will be provided with daily 
disposable contact lenses for the duration of the study at no charge. Subjects will be 
provided with a token for parking at each study visit (if necessary). Subjects will be 
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compensated $40 for completion of each study visit (a total of up to $200 for 5 visits).  
Subjects will be compensated with an Amazon gift cards after completion of the last 
study visit or exit from the study (if early exit due to withdrawal). 
14.0
Compensation for Research-Related Injury 
The risks to subjects from participation in the study are minimal. The clinical procedures 
used in the study are commonly used clinical procedure in optometry and ophthalmology. 
In the rare case that a subject is injured as part of their participation in the study, the 
subject will be responsible for any associated medical bills. 
15.0
Confidentiality 
Subjects will be assigned a unique subject ID. Subjects IDs are two digits and should start 
at 01 and continue in the order of enrollment. No one outside of the research team will 
have access to the subject identifiers. A key to the study code will be maintained for 3 
years at the time of study completion (i.e. Last Subject, Last Visit). 
Any source documents with patient identifiable information will be kept only at the local 
site (informed consent form, linking log). Individual documents will be kept in a locked 
room in The Ocular Surface Institute. 
 
16.0
Provisions to Protect the Privacy Interests of Subjects.
Those who are potentially eligible and interested in the study will be referred to a study 
team member who will discuss the study with the patient. This discussion will take place 
in a quiet, private area and as much time as necessary will be spent discussing the details 
of the study. 
17.0
Informed Consent Process
This trial will follow the University of Houston Division of Research SOP: Informed 
Consent Process for Research (HRP-090). The participant will be provided an opportunity 
to read the informed consent and to have any questions answered before agreeing to 
participate. Prior to any testing, the investigator or study coordinator will obtain written 
informed consent from all participants. The consent form will be signed and dated by both 
the participant and a member of the study personnel who has been approved to obtain 
consent. The participant will receive a copy of the signed consent documents and the 
originals will be filed in the subject binder on site in a secure location. 
18.0
Process to Document Consent in Writing
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The clinical trial will follow the University of Houston Division of Research 
standard operating procedure regarding written documentation of informed 
consent (SOP: Written Documentation of Consent (HRP-091)). The consent form 
will be signed and dated by both the participant and a member of the study 
personnel who has been approved to obtain consent. The participant will receive a 
copy of the signed consent documents and the originals will be filed in the subject 
binder on site in a secure location. A copy of the informed consent document is 
included in the study related documents. 
19.0
HIPAA 
We will be collecting demographic information and general medical and eye health 
information. Since protected health information will be collected, the Health Insurance 
Portability and Accountability Act (HIPAA) authorization form will be included as part 
of the Informed Consent process.  
The linked PHI will be destroyed upon completion of the study and final analysis/report. 
PHI will not be reused or disclosed to any other person or entity, except as required by 
law, for authorized oversight of the research study, or for other research for which the use 
or disclosure of protected health information for which an authorization or opportunity to 
agree or object is not required by 45 CFR 164.512.  
20.0 Data Management
Paper source documents (i.e. case report forms) will only be associated with a subject ID 
number and will not contain direct subject identifiers.
21.0 Specimen Use and Banking
No specimens will be collected in this study.
22.0 Sharing of Results with Subjects 
Subjects will be unmasked at the end of the study and informed of their contact lens 
parameters. The subject may choose to share this information with their eye doctor to 
inform future contact lens fitting needs. 
23.0 Resources 
The study team completed all necessary ethics training requirements. The co-PIs (Eric 
Ritchey, OD, PhD and Kathryn Richdale, OD, PhD) each have over a decade of 
experience conducting clinical care and research and will oversee all study personnel. 
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With an abundance of contact lens wearers in the surrounding community, we 
believe that we should be able to complete enrollment within 6 months.
This study utilizes the clinics of The University Eye Center and The Ocular Surface 
Institute to recruit study subjects on the campus of the University of Houston. 
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Title of research study: Toric Contact Lens Performance Study
Investigators: Kathryn Richdale OD PhD, Eric Ritchey OD PhD
Why am I being invited to take part in a research study?
You are being asked to participate in a research study to help us evaluate the vision and performance of 
different types of contact lenses when used with digital devices. You may be eligible to be in the study 
because you have a certain amount of astigmatism (due to the curvature of the front of your eye).. 
We will be testing different types of soft contact lenses to see how they perform when using digital 
devices. As such, you may get slightly different vision with each set of contact lenses. At the end of the 
study, the study doctors will explain the differences in the contact lenses to you. 
Taking part in this study is entirely voluntary, meaning that you may or may not choose to participate. 
To decide whether or not you want to be part of this research, the risks and possible benefits of the 
study are described in this form so you can make an informed decision. This process is known as 
informed consent. This consent form describes the purpose, procedures, possible benefits and risks of 
the study. This form also explains how your medical information will be used and who may see it. You 
may have a copy of this form to take home to review and ask advice from others. 
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?
The purpose of this research is to better understand how different types of contact lens corrections may 
improve vision and performance, like the ability to read on digital devices. 
How long will the research last?
Each subject should complete the study in less than one month. The study requires 5 visits. Visit 1 will 
last about 2.0 hours and is a baseline screening for eligibility and includes tests to determine which 
contact lens powers you will wear during the study. You will be randomized (like flipping a coin) to 
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which lens design you wear first. All subjects will wear two different designs of contact lenses – each 
for about 1 week. Visit 2 will take less than 1 hour and should be done within 2-5 days from Visit 1. At 
Visit 2 we will check to make sure you are doing well with your contact lenses and make changes to 
the power, if needed, to give you your best vision. Visit 3 will take less than 1.5 hours and should be 
done about 8-12 days after Visit 1. At Visit 3 we will assess your vision and performance with the 
contact lenses and then fit you with the other contact lens design. Visits 4 is the same as Visit 2 but 
with the second design of contact lenses (also a 1 hour visit). At visit 5 we will assess your vision and 
performance with the second contact lens design.
See the tables below for a detailed breakdown of the procedures and estimated study visit timing.
Visit 1 – You can come to this visit wearing your glasses or your current contact lenses
Procedure
Description
Duration
Informed Consent
Review risks, benefits, and purpose of study 
20 mins
Demographics & Medical 
History
Collect info on medical history, current medications, 
contact lens information and demographics
5 mins
Visual Acuity
Measure your vision with your current prescription 
using an eye chart designed for regular eye 
examinations
5 mins
Auto-refraction and auto-
keratometry
A machine will be used to estimate your prescription 
and the shape of your eye
5 mins
Questionnaire
Answer questions about your vision with the contact 
lenses
5 min
High and Low Contrast 
Near Visual Acuity and 
Contrast Sensitivity
Measure your vision at near using special charts with 
more and less contrast (black or grey letters/lines on a 
white background)
10 mins
Radner Reading Test and 
Functional Vision testing 
with iPad
Measure how quickly and easily you are able to read 
on an iPad
15 min
Refraction
Determine your prescription
10 mins
Accommodation, 
Binocular Vision 
Measure how well you focus your eyes and use them 
together as a team. 
10 min
Pupil size
An instrument will measure how big your pupils are in 
dim and bright light
5 min
Slit Lamp Exam 
A microscope will be used to make sure the front 
surface of your eyes are healthy and able to wear 
contact lenses
5 mins
Study Contact Lens Order 
Randomization
You will be randomized (like a flip of a coin) to which 
lens design you wear first. All subjects will wear both 
lens designs if they complete the study.
5 min
Contact Lens Fitting & 
Over-Refraction
Make sure the first contact lenses fit your eyes well 
and the prescription works well
20 mins
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Total Estimated Duration:
2.0 hours
Visit 2 – You should come to this visit wearing your study contact lenses for at least 2 hours
Procedure
Description
Duration
Visual Acuity
Measure vision with your contact lenses using a 
standard eye chart for regular eye examinations
5 min
Contact Lens Assessment 
& Over-Refraction
Make sure the contact lenses still fit your eyes well 
and the prescription works well after you adapted to 
them for a few days
If the vision can be improved, new lenses will be put 
on the eye(s) and allowed to settle, and the vision will 
be checked again.
If the fit or vision are not acceptable you will be exited 
from the study.
20-40 min
Slit Lamp Exam 
A microscope will be used to make sure the front 
surface of your eyes are healthy and able to continue 
wearing contact lenses
5 mins
Total Estimated Duration:
30-50 mins
Visit 3 - You should come to this visit wearing your study contact lenses for at least 2 hours
Procedure
Description
Duration
Visual Acuity
Measure vision with your contact lenses using a 
standard eye chart for regular eye examinations
5 min
Questionnaire
Answer questions about your vision with the contact 
lenses
10 min
High and Low Contrast 
Near Visual Acuity and 
Contrast Sensitivity
Measure your vision at near using special charts with 
more and less contrast (black or grey letters/lines on a 
white background)
15 mins
Radner Reading Test and 
Functional Vision testing 
with iPad
Measure how quickly and easily you are able to read 
on an iPad
20 min
Slit Lamp Exam 
A microscope will be used to make sure the front 
surface of your eyes are healthy and able to continue 
wearing contact lenses
5 mins
Contact Lens Fitting & 
Over-Refraction
Make sure the second contact lens design fits your 
eyes well and the prescription works well
If the fit or vision are not acceptable you will be exited 
20 mins
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from the study.
Total Estimated Duration:
75 mins
Visit 4 – You should come to this visit wearing your study contact lenses for at least 2 hours
Procedure
Description
Duration
Visual Acuity
Measure vision with your contact lenses using a 
standard eye chart for regular eye examinations
5 min
Contact Lens Assessment 
& Over-Refraction
Make sure the contact lenses still fit your eyes well 
and the prescription works well after you adapted to 
them for a few days
If the vision can be improved, new lenses will be put 
on the eye(s) and allowed to settle, and the vision will 
be checked again.
If the fit or vision are not acceptable you will be exited 
from the study.
20-40 min
Slit Lamp Exam 
A microscope will be used to make sure the front 
surface of your eyes are healthy and able to continue 
wearing contact lenses
5 mins
Total Estimated Duration:
30-50 mins
Visit 5 - You should come to this visit wearing your study contact lenses for at least 2 hours
You should bring your glasses or contact lenses to wear home from the study.
Procedure
Description
Duration
Visual Acuity
Measure vision with your contact lenses using a 
standard eye chart for regular eye examinations
5 min
Questionnaire
Answer questions about your vision with the contact 
lenses
10 min
High and Low Contrast 
Near Visual Acuity and 
Contrast Sensitivity
Measure your vision at near using special charts with 
more and less contrast (black or grey on white)
15 mins
Radner Reading Test and 
Functional Vision testing 
with iPad
Measure how quickly and easily you are able to read 
on an iPad
20 min
Slit Lamp Exam 
A microscope will be used to make sure the front 
surface of your eyes are healthy and able to continue 
wearing contact lenses
5 mins
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Total Estimated Duration:
55 mins
How many people will be studied? 
We expect to start about 38 people. 
We expect 34 people to complete the study.
What happens if I say yes, I want to be in this research?
All of the tests done during the study are described above. All of the contact lenses used in the study 
are FDA approved. The eye examination and contact lens fitting are the same as what is done in 
standard clinical care. The questionnaires and special vision and reading testing are done for research 
purposes to get a better idea of how subjects are performing with the contact lenses. 
An iPad app will be used to measure your reading performance. This iPad App used the FaceTime 
camera to track your blinks and eye movements, as well as to make sure that you are properly lined up 
with the device, 
This research study will be conducted at The Ocular Surface Institute by trained study personnel. 
Optometrists (eye doctors) will fit the contact lenses and conduct the eye examination portion. A 
research assistant may help with the questionnaire and visual performance testing.
The contact lens design you wear first will be chosen by chance, like flipping a coin. You will have 
equal chance of starting with either lens design treatment. Neither you nor the study doctor evaluating 
your performance will know which lens design you are using. 
What are my responsibilities if I take part in this research?
If you agree to be a part of this research, you will be responsible for wearing the assigned contact 
lenses at least 8 hours a day on the days between the study visits. You will also need to adhere to the 
dates and times for study visits and wear the assigned contact lenses for at least two hours before 
coming to the study visits (Visit 2-5). 
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 and/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. 
If you are an employee of the University of Houston, a decision to take part or not, or to withdraw 
from the research will have no effect on your employment with the University of Houston
If you chose not to be in this study, you can ask your eye doctor if you can be fitted or toric contact 
lenses. 
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.
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If you decide to leave the research, you will not be compensated for your study visits after you exit the 
study and the data collected up to the point of study exit may still be used. If you decide to leave the 
study, contact the investigator. The study investigator will want to talk to you or see you to make sure 
that you are okay and your eyes are still healthy. 
If you stop being in the research, already collected data may not be removed from the study database. 
You will be asked whether the investigator can collect data from your routine medical care. If you 
agree, this data will be handled the same as research data. 
Is there any way being in this study could be bad for me?
The risks to subjects from participation in the study are minimal. The procedures in the study (slit lamp 
exam, contact lens fitting, etc.) are commonly used clinical procedures in optometry and 
ophthalmology. 
Commercially available (FDA approved) contact lenses will be fit as part of this study. While most 
individuals wear contact lenses without problems, there are some risks associated with wearing contact 
lenses. Ulcerative keratitis (infection of the clear front part of the eye), is the most severe risk and can 
lead to loss of vision. Ulcerative keratitis is estimated to happen to about 1-2 out of 10,000 people who 
use daily wear daily disposable contact lenses. The risk in this study is no different than the risk if your 
eye care provider fit you in contact lenses. The risk of ulcerative keratitis may be reduced by carefully 
following the study doctor’s directions for lens care including throwing out your contact lenses each 
night, never sleeping or napping in contact lenses, and never exposing your contact lenses to water.
The following problems may also occur when wearing contact lenses:

Other, less serious, infections or inflammation of the eye(s)

Burning, stinging, itching, dryness or general irritation of the eye(s)

Corneal neovascularization (small blood vessels growing into the cornea) 

Excessive watering, unusual eye secretions (such as mucus), or redness of the eye(s)

Reduced or blurred vision (compared to glasses)

Seeing rainbows or halos around bright lights (compared to glasses)
In the event you experience signs or symptoms associated with one of the problems listed 
above, you should immediately contact the The Ocular Surface Institute at 713-743-2849 
(during regular business hours) or the study Principal Investigator, Dr. Kathryn Richdale, at 
917-755-4548 or Dr. Eric Richey at 614-596-7477 (outside business hours).
Will I get anything for being in this study?
If you are eligible for the study and complete all 5 study visits you will receive a $200 Amazon gift 
card ($40/visit for 5 visits). If you attend the first visit but are not eligible (screen fail), you will receive 
a $40 Amazon gift card for Visit 1. If you are exited from the study at a later visit (due to problems 
with the fit or vision of the contact lenses, or not attending the study visits as assigned), you will only 
be paid for the study visits that you completed on time. You will be paid when you complete or 
otherwise exit the study. 
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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. Subjects may 
be unmasked (told what each of their study lenses were) at the end of the study. Through this they may 
learn more about their vision and visual performance with different types of contact lenses. 
Participation in the study may also improve the fitting of toric contact lenses for future patients. 
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 IRB 
and other representatives of this organization, as well as collaborating institutions and federal agencies 
that oversee human subjects research. The sponsor of the research (Alcon) may also review research 
records upon request. 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. 
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. 
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by 
U.S. Law. This website will not include information that can identify you. At most, the Web site will 
include a summary of the results. You can search this website at any time.
Can I be removed from the research without my OK?
The person in charge of the research study or the sponsor can remove you from the research study 
without your approval. Possible reasons for removal include if you do not attend the study visits or the 
do not have acceptable vision or fit with the contact lenses. 
We will tell you about any new information that may affect your health, welfare, or choice to stay in 
the research.
What else do I need to know?
If you need medical care because of taking part in this research study, contact the investigator and 
medical care will be made available. Generally, this care will be billed to you, your insurance, or other 
third party. The University of Houston has no program to pay for medical care for research-related 
injury. 
Who can I talk to?
If you have questions, concerns, or complaints, or think the research has hurt you, you can email Dr. 
Richdale (Richdale@uh.edu) or Dr. Ritchey (erritche@Central.UH.EDU) or call and ask to speak to 
one of them (713-743-2849).
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:
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
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.
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Si g n at ure Bl oc k f or C a p a ble A d ult
Y o ur si g nat ure d oc u me nts y o ur c o nse nt t o ta ke part i n t his  researc h.
Si g nat ure of s u bject
Date
Pri nte d na me of s u bject
Si g nat ure of pers o n o btai ni n g c o nse nt
Date
Pri nte d na me of pers o n o btai ni n g c o nse nt
 I n t he f ut ure, o ur researc h tea m ma y be i ntereste d i n c o ntacti n g y o u f or ot her researc h st u dies we 
u n derta ke, or t o c o n d uct a f oll o w- u p st u d y  t o t his o ne. T here is never a ny o bli g ati o n t o t a ke p art i n 
a d diti o n al rese arc h.  D o we ha ve per missi o n t o c o ntact y o u t o pr o vi de a d diti o nal i nf or mati o n?

Yes

S T U D Y 0 0 0 0 0 6 8 2
U H I R B A p pr o v e d
9/ 1 2/ 2 0 1 8 - 3/ 2 8/ 2 0 1 9
N o