Treating Contact Lens Discomfort With Orthokeratology
Phase: NA
Conditions: Dry Eye, Contact Lens Complication
Sponsor: University of Alabama at Birmingham

Treating Contact Lens Discomfort With Orthokeratology 
 
 
Study Protocol & Statistical Analysis Plan 
NCT03566680 
 
April 1, 2020 
 
 
Andrew Pucker, O.D.,PhD, Principal Investigator 
University of Alabama at Birmingham 
Birmingham, AL 35294 

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Treating Contact Lens Discomfort with Orthokeratology 
 
Principal Investigator: 
Andrew D. Pucker, OD, PhD, FAAO 
 
Co-Investigators: 
Kim Duong, OD, MS 
Jared Cox, OD 
 
 
 
University of Alabama at Birmingham 
School of Optometry 
716 University Blvd 
Birmingham, AL 35233 
apucker@uab.edu 
(920) 579-2900 

Version 2: 05/14/2018 
 
INTRODUCTION & RATIONALE 
 
Soft contact lenses (SCL) are the most common CL modality, used by over 140 million people in the 
world.1,2 Despite many improvements in CL materials, solutions, and the addition of rewetting drops to 
improve comfort, research has shown that approximately half of established CL wearers permanently 
discontinue CL wear because of ocular dryness and discomfort.3,4 The symptoms and decreased 
wear times associated with Contact Lens Discomfort (CLD) are likely related to dry eye disease and 
meibomian gland dysfunction.3,5-8 However true CLD, as defined by the International Workshop on 
Contact Lens Discomfort, only exists while wearing CLs.9 
In a survey conducted by Dumbleton et al., half of previous and current CL wearers reported they 
would like to be able to wear CL for more hours during the day.10 Of those who discontinued CL wear, 
the number one reason for shorter CL wear time was lens discomfort. Of those who discontinue CL 
wear, higher proportions were in daily disposable CLs.10 Even with the introduction of 
siliconehydrogel materials and daily disposable CLs, reports of CL discomfort and discontinuation 
continue to be relatively steady.10-12 Those who discontinued CL wear tend to be of older age and 
have worn CL for a shorter amount of time than current wearers.8,10 
Given that wearing CLs is the primary instigator of CLD, avoiding CL wear during the day could 
eliminate the symptoms related to longs hours of CL wear. In fact, CL removal is a primary way that 
patients with CLD treat their condition.7 One-way to avoid CLD during the day could be to wear 
orthokeratology lenses. Orthokeratology is a form of corneal reshaping rigid CL that is worn primarily 
during sleep to temporarily reduce refractive error and free patients from CLs or spectacles while 
awake.13,14 According to Richdale et al., 40 percent of those who discontinued CL wear reported 
having or wanting to have refractive surgery.8 Orthokeratology can offer an alternative to refractive 
surgery for the patients who are interested or who are not currently a candidate for surgery.15 
Orthokeratology CLs have yet to be fully explored for the treatment of CLD, though some support for 
this practice exists in the literature. Carracedo et al., Lipson et al., and Garcia-Porta et al. found that 
orthokeratology resulted in better ocular comfort than SCLs.11,16,17 Nevertheless, all three studies 
excluded subjects who had been diagnosed with dry eye and all three studies used symptoms 
surveys that were not specific to assessing CLD. Garcia-Porta et al.’s study was also limited by 
included both neophytes and established CL wearers.11 Yet, these studies overall suggest that 
orthokeratology could be used as a treatment for CLD, and one case report has even found that 
orthokeratology is a viable option for treating CL intolerance.18 
To date, there has yet to be a study fully investigating orthokeratology as an alternative to SCL use in 
patients with CLD. Therefore, the purpose of this study is to formally investigate if orthokeratology is a 
good alternative to SCLs for patients who are experiencing CLD or for patients who have dropped out 
of CLs because of CLD. This study will also simultaneity evaluate the neophyte orthokeratology 
wearing experience with hopes of finding additional means for improving CL comfort. Knowing the 
success of orthokeratology in wearers with CLD will allow practitioners to better help and prescribe for 
those who may have experienced or at risk for experiencing CLD. It may also be a way to allow 
patients additional years of CL wear. 

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SPECIFIC AIMS 
 
This study will address the following specific aims and associated hypotheses: 
Aim 1: Determine if refitting patients into orthokeratology can improve ocular symptoms in 
SCL wearers who have CLD. Hypothesis 1: Orthokeratology will provide better comfort than 
SCLs in patients who experience CLD. 
 
Aim 2: Gain a comprehensive understanding of a neophyte orthokeratology wearer’s 
initial wearing experience. Hypothesis 2: Neophyte orthokeratology wearers are able to quickly 
adapt to orthokeratology and easily learn the process of orthokeratology CLs wear. 
 
STUDY DESIGN 
 
Subjects & Sample Size: 
 
This will be a multi-visit study conducted at the University of Alabama at Birmingham (UAB). Subjects 
will be recruited from UAB’s patient database and the greater Birmingham, AL area via postcards, 
email, social network postings (i.e., Facebook), or fliers. Subjects who self-report that they experience 
CLD while wearing SCLs or report that they have recently discontinued CL use because of discomfort 
will be recruited to participate in the study. Subjects will then be screened with the Contact Lens Dry 
Eye Questionnaire (CLDEQ)-8, and subjects who have clinically meaningful (CLDEQ-8 scores ≥ 12, 
which is an established cutoff) CLD will be enrolled in the study.19 Recent CL dropouts (<6 months) 
will be asked to report to the study while wearing a pair of their most recently prescribed SCLs. 
CLDEQ-4 scores (Rasch validated version; max score of 18) will serve as the primary outcome in this 
study. Internal data from my laboratory suggests that the average contact lens wearer has a mean 
CLDEQ-4 score of 7.6 ± 3.8. A 4-point difference in CLDEQ-4 scores will be considered a clinically 
meaningful improvement in CL comfort when comparing CL comfort at baseline to the 1-month, main 
outcome visit. Therefore, 30 subjects will be needed to determine if orthokeratology CLs are able to 
improve CLD (power = 80%; alpha = 0.05). After adjusting for 20% dropout, a total sample size of 36 
subjects will be needed to complete the objectives of this study. An additional six subject are being 
requested in case subjects screen fail during the baseline visit; therefore, a total sample size of 42 will 
be requested; however, only a maximum of 36 subjects will be treated with orthokeratology. 
 
Inclusion and Exclusion Criteria: 
 
Subjects between 18 and 45 years of age who have completed a comprehensive eye exam within the 
past two years will be recruited. Subjects will then be asked to enroll in the clinical study if they 
indicate that they have CLD or if they have discontinued CL use because of discomfort within the past 
6 months. Subjects must meet the refractive requirements of the Emerald™ Contact Lens (Oprifocon 
A, Euclid Systems Corporation), which include having -5.00 diopters or less myopia with less than 
1.50 diopters of cylinder and keratometry values between 40.00 D and 46.00 D. 

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Subjects will also be excluded if they have a history of past orthokeratology use, a history of herpetic 
eye disease, a history of ocular surgery within the past 12 months, a history of severe ocular trauma, 
active ocular infection or inflammation, ocular disease other than dry eye, are currently using Accutane 
or ocular medications, or if they are pregnant or breast feeding. Subjects with a condition or in a 
situation, which in the examiner’s opinion, may put the subject at significant risk, may confound the 
study results, or may significantly interfere with their participation in the study will also be excluded. 
 
Subject Screening: 
 
All subjects will be pre-screened with a scripted phone interview to verify that they meet all potential 
inclusion and exclusion criteria. Eligible subjects will then be invited to participate in the clinical study. 
 
Methods: 
 
All clinical measurement will be obtained from both eyes of each eligible subject and testing will be 
performed in the below order. Testing order was designed to sequentially administer the least 
invasive to most invasive test. This methodology will ensure that a previous procedure will have a 
minimal effect on all subsequent assessments.20 
 
Baseline Visit (Visit One) 
 
1. 
Subject History, Eligibility, Informed Consent: Completion of an eye exam within the past two 
years will be verified at this time by obtaining a signed, unexpired glasses prescription or some other 
form of documentation from each study subject’s eye care provider. Subjects will also be required to 
provide documentation of their most recent CL prescription at this time (e.g., CL prescription, CL 
boxes). Subjects will then be required to complete the CLDEQ-8 to verify that they have clinically 
meaningful CL discomfort. Non-eligible subjects will be dismissed at this time or rescheduled 
depending upon the reason for ineligibility. Eligible subjects will be enrolled, consented, and 
requested to sign a health privacy document at this time. 
 
2. 
Questionnaires: All subjects will be asked to complete the Standard Patient Evaluation of Eye 
Dryness (SPEED) Questionnaire to acquire an additional measure of dry eye severity, an 
orthokeratology quality of life survey (University of Michigan Vision Correction Quality of Life), and a 
study specific survey to better understand the patient’s health and CL history.21,22 
 
3. 
Visual Acuity: The subject’s best correct visual acuity with most recent CL will be measured 
with a high-contrast Bailey-Lovie (logMAR) chart, and visual acuity will be recorded in both Snellen 
and logMAR. 
 
Note: Habitual contact lenses will be removed at this time by the patient. 
 
4. 
Pupil Size: Pupils will be measured under standard lighting conditions and under dim 
conditions with an optometric millimeter ruler. 

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5. 
Manifest Refraction: The investigator may use an autorefractor to obtained a baseline 
understanding of the patient’s refractive error. The investigator will determine the subject’s refractive 
error with a phoropter, and binocular balance will be performed if best-corrected visual acuity is equal 
in between eyes. 
6. 
Slit-Lamp Biomicroscopy: A slit-lamp biomicroscope will be used to document normal and/or 
remarkable findings of the anterior eye structures: eyelashes (blepharitis), eyelids, conjunctiva, and 
cornea. Eyelids will be graded based upon a grading scale that was developed by the investigators. 
 
7. 
Non-invasive break-up time (NIBUT): The Oculus Keratograph 5M multifunctional topographer 
will be used to determine the subject’s NIBUT.23 The Keratograph 5M will be positioned over the 
subject’s eye and then focused. The subject will then be asked to look into the instrument and be 
asked to blink three times. After the third blink, the subject will be asked to keep their eyes open and 
to not blink for as long as possible. The investigator will use a stopwatch to determine the number of 
seconds required for the first distortion to appear in the array of Placido disk rings. The subject will 
then be allowed to blink normally for ten seconds before repeating the procedure on the fellow eye. 
NIBUT will be repeated in triplicate for each eye and averaged. 
8. 
Tear Meniscus Height: The Keratograph 5M will be used to determine the subject’s tear 
meniscus height.23 The subject will be asked to blink at a normal rate and remain still until the 
investigator has captured the image to measure the tear meniscus height. Three pictures will be 
captured per each eye to minimize the dynamic variability of tear volume with blinking. 
 
9. 
Phenol Red Thread: Tear volume will be assessed with PRTT while the subject is sitting at the 
Keratograph 5M. In brief, a string will be placed at the temporal third of the lower right eyelid. The 
subject will then be asked to close their eyes lightly for 15 seconds. The examiner will then measure 
the length of wetting. 
 
10. 
Conjunctival Staining: A sterile lissamine green strip will be wet with sterile saline and applied 
to the superior bulbar conjunctiva. After waiting two minutes, conjunctival staining will be assessed 
while the subject is looking laterally (right & left). The severity of staining will be graded in 6 
conjunctival zones per eye following the NEI scale.24 
11. 
Aesthesiometer: The aesthesiometer filament will be extended to full length and applied to the 
cornea. The filament will be retracted until the subject is able to feel the filament and the filament 
length will be recorded. 
 
12. 
Corneal Topography: The investigator will use the Keratograph 5M to obtain keratometry 
values and horizontal visible iris diameter (HVID) with the instrument’s standard software. 
 
13. 
CL Fitting: All subjects will be fitted empirically with the Emerald™ Contact Lens for Overnight 
Orthokeratology (Oprifocon A, Euclid Systems Corporation) based upon the baseline measurements 
obtained above (refraction, topography, horizontal visible iris diameter), and CLs will be ordered 
accordingly. The subject will be scheduled for a dispense visit, which will take place about one week 
after their baseline visit. 

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Dispense Visit (Visit Two) 
 
1 Visual Acuity: A Bailey-Lovie (logMAR) chart will be used to evaluate visual acuity as described 
above. 
2. 
Slit-Lamp Biomicroscopy: A slit-lamp biomicroscope will be used to evaluate ocular health as 
described above. 
 
3. 
CL Dispense: Orthokeratology contact lenses will be dispensed and evaluated according to 
Emerald’s fitting guide. Soft contact lens will also be evaluated for temporary use while vision is 
stabilizing with orthokeratology contact lenses (1-day Acuvue Moist). 
 
4. 
Application and Removal Training: The patient will be educated how to properly use their CLs. 
The subject will also be giving health education materials (Healthy Gas Permeable Contact Lens 
Habits form) that will best direct them how to use their CLs while at home, and they will be given all 
needed care products (ClearCare [hydrogen peroxide care system]) and trial soft CLs to help with 
vision while adjusting to orthokeratology (1-day Acuvue Moist). If the patient successfully completes 
the application and removal training, they will be schedule for their one-day follow up visit. If they fail 
their training session, they will be rescheduled for an additional training session. 
 
Day One Visit (Visit Three) 
 
1. Questionnaires: All subjects will be asked to complete the CLDEQ-8 and SPEED Questionnaires to 
judge CL and ocular comfort. 
 
2. Visual Acuity: The subject’s visual acuity will be measured with a high-contrast Bailey-Lovie 
(logMAR) chart, and visual acuity will be recorded in both Snellen and logMAR. 
 
3. Slit-Lamp Biomicroscopy: A slit-lamp biomicroscope will be used to evaluate ocular health as 
described above. 
 
4. Non-invasive break-up time (NIBUT): The Oculus Keratograph 5M multifunctional topographer will 
be used to determine the subject’s NIBUT as described above.23 
5. Tear Meniscus Height: The Keratograph 5M will be used to determine the subject’s tear meniscus 
height as described above.23 
 
6. Phenol Red Thread: A PRT will be used to evaluate tear volume as described above. 
 
7. Conjunctival Staining: Lissamine green will be used to evaluate conjunctival staining as described 
above. 
8. Aesthesiometer: An aesthesiometer will be used to evaluate corneal sensitivity as described 
above. 

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9. CL Evaluation: The subject’s CLs will be evaluated as directed by Emerald’s fitting guide (visual 
acuity, refraction, topography). No lens adjustments will be made at this time unless absolutely 
medically necessary. The subject will be schedule for their 1-week follow-up visit. 
 
One-Week Visit (Visit Four) 
1. Questionnaires: All subjects will be asked to complete the CLDEQ-8 and SPEED Questionnaires to 
judge CL and ocular comfort. The subject will also be asked to complete an investigator-designed 
survey that is aimed at understanding the patient’s initial wearing experience. 
 
2. Visual Acuity: A Bailey-Lovie (logMAR) chart will be used to evaluate visual acuity as described 
above. 
 
3. Slit-Lamp Biomicroscopy: A slit-lamp biomicroscope will be used to evaluate ocular health as 
described above. 
 
4. Non-invasive break-up time (NIBUT): The Oculus Keratograph 5M multifunctional topographer will 
be used to determine the subject’s NIBUT as described above.23 
5. Tear Meniscus Height: The Keratograph 5M will be used to determine the subject’s tear meniscus 
height as described above.23 
 
6. Phenol Red Thread: A PRT will be used to evaluate tear volume as described above. 
 
7. Conjunctival Staining: Lissamine green will be used to evaluate conjunctival staining as described 
above. 
8. Aesthesiometer: An aesthesiometer will be used to evaluate corneal sensitivity as described 
above. 
 
9. CL Evaluation: The subject’s CLs will be evaluated as directed by Emerald’s fitting guide (visual 
acuity, refraction, topography). Lens adjustments will be made at this time if the contact lens fit is 
deemed unacceptable, and the appropriate follow-up visit will be scheduled. If the lens fit is 
deemed acceptable, the subject will be schedule for their 1-month follow-up visit. 
 
One-Month Visit (Visit Five) 
 
1. Questionnaires: All subjects will be asked to complete the CLDEQ-8, University of Michigan Vision 
Correction Quality of Life, and SPEED Questionnaires to judge CL and ocular comfort. The subject 
will also be asked to complete an investigator-designed survey that is aimed at understanding the 
patient’s initial wearing experience. 
 
2. Visual Acuity: A Bailey-Lovie (logMAR) chart will be used to evaluate visual acuity as described 
above. 

Version 2: 05/14/2018 
 
3. Slit-Lamp Biomicroscopy: A slit-lamp biomicroscope will be used to evaluate ocular health as 
described above. 
 
4. Non-invasive break-up time (NIBUT): The Oculus Keratograph 5M multifunctional topographer will 
be used to determine the subject’s NIBUT as described above.23 
5. Tear Meniscus Height: The Keratograph 5M will be used to determine the subject’s tear meniscus 
height as described above.23 
 
6. Phenol Red Thread: A PRT will be used to evaluate tear volume as described above. 
 
7. Conjunctival Staining: Lissamine green will be used to evaluate conjunctival staining as described 
above. 
8. Aesthesiometer: An aesthesiometer will be used to evaluate corneal sensitivity as described 
above. 
 
9. CL Evaluation: The subject’s CLs will be evaluated as directed by Emerald’s fitting guide (visual 
acuity, refraction, topography), and the subject will be asked if they wish to continue wearing the 
CLs. If the subject would like to keep wearing the CLs, their prescription will be released at this 
time. All subjects will then be released from the clinical portion of the study. 
 
Three-Month Visit (Visit Six) 
 
1. Phone Survey: All subjects will be asked to complete an investigator-designed survey to gauge the 
patient’s satisfaction with orthokeratology. All subjects will also be asked to complete the CLDEQ-8, 
University of Michigan Vision Correction Quality of Life, and SPEED Questionnaires to judge CL and 
ocular comfort. The surveys will be sent electronically to the subject to be completed, and if the 
patient fails to complete the surveys electronically, the subject will be called to administer the survey 
over the phone. All subjects will be released from the study after the completion of this survey. 
 
DATA ENTRY AND MANAGEMENT 
 
Surveys will be administered via a secured web service (https://www.qualtrics.com/) at the time of the 
study visit, and exam data will be entered into the same site after the completion of each study visit. 
The online survey instrument will be designed on Qualtrics software. All data will be stored on 
Qualtrics servers, which meet the Health Insurance Portability and Accountability Act (HIPAA) 
standards and are secured against both physical and digital intrusion. Qualtrics will not be able to 
access subject’s responses unless a request is made by the Principal Investigators to Qualtrics for 
assistance that would require their involvement with the data. All access is password protected, and 
data will only be stored electronically. 
 
Risk to subjects, including a breach of confidentiality, is mitigated by the security measures utilized by 
Qualtrics. Physical access to the servers storing survey results is protected by a 24-hour security 
team, keycard and biometric authentication, digital surveillance, internally located server housings, 

Version 2: 05/14/2018 
 
and backup power generation. Data are also protected digitally by three mirrored Network Operations 
Centers, which monitor both local and regional networks including: points of presence, telecom 
facilities, routers, servers, and customer’s infrastructure. Data are backed up at different locations in 
the compound via replication services, and nightly hard copies are generated and stored in a secure 
location. Workstations located inside the compound do not allow for remote access and do not 
contain any third-party software. 
 
DATA ANALYSIS 
 
All data collected with Qulatrics will be exported into an Excel spreadsheet, and STATA 15 will be 
used to compare CL comfort and factors over time. Means and standard deviations will be used to 
understand data trends while analysis of variance (ANOVA) will be used to make direct comparison 
between subjects at the different study visits. Regression analysis will be used to understand factors 
associated with CL comfort and patient satisfaction. 
 
INVESTIGATOR TRAINING 
 
All study investigators will be required to read the protocol, and they will also undergo an in-person 
training run by Dr. Pucker before they will be certified to examine study subjects. 
 
AUTHORSHIP 
 
Named author (e.g., abstract, manuscript) will be required to meet at least two of the basic 
requirements of authorship, which include substantially contributing to study design, collecting data, 
and critically reviewing the results and publication. If an author does not meet any of the listed 
requirements, they will be excluded from the publication. If the investigator only meets one of the 
requirements, they will be acknowledged in the manuscript. 
 
CONCLUSION 
 
After completion of this study, the scientific and clinical communities will have a better understanding 
of the utility of using orthokeratology for the treatment of CLD. They will also have better insight into 
the neophyte orthokeratology wearer’s initial experience with orthokeratology CLs. Overall, this 
knowledge will help guide practitioners who are attempting to treat CLD, and it will result in 
bettertargeted patient education for neophyte orthokeratology CL wearers. 
 
REFERENCES 
 
1. 
Cope JR, Collier SA, Rao MM, et al. Contact Lens Wearer Demographics and Risk Behaviors 
for Contact Lens-Related Eye Infections--United States, 2014. MMWR Morbidity and mortality 
weekly report. 2015;64(32):865-870. 
2. 
Morgan PB, Woods CA, Tranoudis IG. International Contact Lens Prescribing in 2015. Contact 
Lens Spectrum. 2006;31:24-29. 

Version 2: 05/14/2018 
 
3. 
Pritchard N, Fonn D, Brazeau D. Discontinuation of contact lens wear: a survey. Int Contact 
Lens Clin. 1999;26(6):157-162. 
4. 
Young G, Veys J, Pritchard N, Coleman S. A multi-centre study of lapsed contact lens 
wearers. Ophthalmic Physiol Opt. 2002;22(6):516-527. 
5. 
Nichols JJ, Ziegler C, Mitchell GL, Nichols KK. Self-reported dry eye disease across refractive 
modalities. Investigative ophthalmology & visual science. 2005;46(6):1911-1914. 
6. 
Korb DR, Henriquez AS. Meibomian gland dysfunction and contact lens intolerance. J Am 
Optom Assoc. 1980;51(3):243-251. 
7. 
Begley CG, Chalmers RL, Mitchell GL, et al. Characterization of ocular surface symptoms from 
optometric practices in North America. Cornea. 2001;20(6):610-618. 
8. 
Richdale K, Sinnott LT, Skadahl E, Nichols JJ. Frequency of and factors associated with 
contact lens dissatisfaction and discontinuation. Cornea. 2007;26(2):168-174. 
9. 
Nichols JJ, Willcox MD, Bron AJ, et al. The TFOS International Workshop on Contact Lens 
Discomfort: executive summary. Investigative ophthalmology & visual science. 
2013;54(11):TFOS7-TFOS13. 
10. 
Dumbleton K, Woods CA, Jones LW, Fonn D. The impact of contemporary contact lenses on 
contact lens discontinuation. Eye & contact lens. 2013;39(1):93-99. 
11. 
Garcia-Porta N, Rico-Del-Viejo L, Martin-Gil A, Carracedo G, Pintor J, Gonzalez-Meijome JM. 
Differences in Dry Eye Questionnaire Symptoms in Two Different Modalities of Contact Lens 
Wear: Silicone-Hydrogel in Daily Wear Basis and Overnight Orthokeratology. Biomed Res Int. 
2016;2016:1242845. 
12. 
Chalmers RL, Begley CG. Dryness symptoms among an unselected clinical population with 
and without contact lens wear. Contact lens & anterior eye : the journal of the British Contact 
Lens Association. 2006;29(1):25-30. 
13. 
Caroline PJ. Contemporary orthokeratology. Contact lens & anterior eye : the journal of the 
British Contact Lens Association. 2001;24(1):41-46. 
14. 
Dave T, Ruston D. Current trends in modern orthokeratology. Ophthalmic Physiol Opt. 
1998;18(2):224-233. 
15. 
Swarbrick HA. Orthokeratology (corneal refractive therapy): what is it and how does it work? 
Eye & contact lens. 2004;30(4):181-185; discussion 205-186. 
16. 
Carracedo G, Martin-Gil A, Fonseca B, Pintor J. Effect of overnight orthokeratology on 
conjunctival goblet cells. Contact lens & anterior eye : the journal of the British Contact Lens 
Association. 2016;39(4):266-269. 
17. 
Lipson MJ, Sugar A, Musch DC. Overnight corneal reshaping versus soft disposable contact 
lenses: vision-related quality-of-life differences from a randomized clinical trial. Optom Vis Sci. 
2005;82(10):886-891. 
18. 
López-Lópeza MPn-Sn, J. M; Sobrado-Calvob, P.; García-Ayusob,D. . Contact lens 
intolerance: 
refitting with dual axis lens for corneal refractive therapy. Journal of Optoemtry 2010. 
19. 
Chalmers RL, Keay L, Hickson-Curran SB, Gleason WJ. Cutoff score and responsiveness of 
the 8-item Contact Lens Dry Eye Questionnaire (CLDEQ-8) in a Large daily disposable contact 
lens registry. Contact lens & anterior eye : the journal of the British Contact Lens Association. 
2016;39(5):342-352. 

Version 2: 05/14/2018 
 
20. 
Bron AJ, Evans VE, Smith JA. Grading of corneal and conjunctival staining in the context of 
other dry eye tests. Cornea. 2003;22(7):640-650. 
21. 
Ngo W, Situ P, Keir N, Korb D, Blackie C, Simpson T. Psychometric properties and validation 
of the Standard Patient Evaluation of Eye Dryness questionnaire. Cornea. 2013;32(9):1204- 
1210. 
22. 
McAlinden C, Lipson M. Orthokeratology and Contact Lens Quality of Life Questionnaire 
(OCLQoL). Eye Contact Lens. 2017. 
23. 
Pucker AD, Jones-Jordan LA, Li W, et al. Associations with Meibomian Gland Atrophy in Daily 
Contact Lens Wearers. Optom Vis Sci. 2015;92(9):e206-213. 
24. 
Lemp MA. Report of the National Eye Institute/Industry workshop on Clinical Trials in Dry 
Eyes. The CLAO journal : official publication of the Contact Lens Association of 
Ophthalmologists, Inc. 1995;21(4):221-232. 

Page 1 of 7 
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CONSENT FORM 
 
Title of Research: 
Treating Contact Lens Discomfort with Orthokeratology 
 
UAB IRB Protocol #: 
IRB-300001681 
 
Principal Investigator: 
Andrew D. Pucker, OD, PhD 
 
Sponsor: 
Euclid Systems 
 
 
Purpose of the Research 
 
We are asking you to take part in a research study on eye comfort. The purpose of this research is to 
investigate if orthokeratology (overnight hard contact lenses) is a good alternative to soft contact 
lenses for patients who are experiencing contact lens related discomfort. Orthokeratology is a FDA 
approved contact lens worn while you sleep that temporarily reshapes the front of your eye, so you 
can see well without contact lenses during the day. Given that contact lenses are a primary reason 
why people have uncomfortable eyes during the day, avoiding contact lenses while awake may 
eliminate the symptoms associated with contact lens. We plan to enroll 42 participants in this study. 
 
Explanation of Procedures 
 
Study visits: 
 
You will arrive to at least 6 study visits. You will come for about five one-hour office visits over the 
period of one month (number of visits may vary based upon the contact lens fitting process). The 
sixth visit will be conducted either electronically or by phone and will last about 10 minutes. 
• Visit #1: Baseline measurement 
o During this visit, your history and consent to be in the study will be obtained and 
your eligibility for the study will be determined. You will be asked to fill out four 
questionnaires (CLDEQ-8, University of Michigan Vision Correction Quality of Life, 
and SPEED Questionnaires, Study Specific Contact Lens Questionnaire). The 
following procedures will be performed: visual acuity, pupil size, manifest 
refraction, slit-lamp biomicroscopy, non-invasive break-up time, topography, tear 
meniscus height, phenol red thread, conjunctival staining, corneal esthesiometry, 
and contact lens fitting. 
• Visit #2: Contact lens dispense 
o During this visit, your visual acuity will be obtained and your anterior eye health 
will be evaluated using slit-lamp biomicroscopy. The orthokeratology contact 
lenses will be dispensed and evaluated. Soft contact lens will also be evaluated for 
temporary use while vision is stabilizing with the orthokeratology contact lenses. 
You will be educated on how to properly use the contact lenses, including how to 
apply, remove and care for the contact lenses. If you are unable to safely apply and 

Page 2 of 7 
Version Date: 06/27/2018 
 
remove your contact lenses, you will be rescheduled for an additional training 
session. 
• Vistit#3: One-day follow-up 
o During this visit you will be asked to complete three questionnaires (CLDEQ-8 and 
SPEED Questionnaires, Study Specific Contact Lens Questionnaire). The following 
procedures will be performed: visual acuity, pupil size, manifest refraction, slit- 
lamp biomicroscopy, non-invasive break-up time, topography, tear meniscus 
height, phenol red thread, conjunctival staining, corneal esthesiometry, and 
contact lens evaluation. If the contact lens are not providing adequate vision or fit, you will 
be asked to return for additional visits until the vision and fit are adequate. 
• Visit #4: One-week follow-up 
o During this visit you will be asked to complete three questionnaires (CLDEQ-8 and 
SPEED Questionnaires, Study Specific Contact Lens Questionnaire). The following 
procedures will be performed: visual acuity, pupil size, manifest refraction, slit- 
lamp biomicroscopy, non-invasive break-up time, topography, tear meniscus 
height, phenol red thread, conjunctival staining, corneal esthesiometry, and 
contact lens evaluation. If the contact lens fit does not provide adequate vision or fit, you 
will be asked to return for additional visits until the fit is adequate. 
• Visit #5: One-month follow-up 
o During this visit you will be asked to complete four questionnaires (CLDEQ-8 and 
SPEED, University of Michigan Vision Correction Quality of Life Study Specific 
Contact Lens Questionnaire). The following procedures will be performed: visual 
acuity, pupil size, manifest refraction, slit-lamp biomicroscopy, non-invasive 
break-up time, topography, tear meniscus height, phenol red thread, conjunctival 
staining, corneal esthesiometry, and contact lens evaluation. 
• Visit #6: Complete a survey electronically or through the phone at 3 months 
o During this visit you will be asked to complete four surveys (CLDEQ-8, University 
of Michigan Vision Correction Quality of Life, and SPEED Questionnaires, Study 
Specific Contact Lens Questionnaire) electronically. If you fail to complete the 
surveys electronically, you will be called to administer the survey over the phone. 
 
The diagnostic procedures used in this protocol are those that make up a typical eye examination or a 
dry eye evaluation. If you agree to join the study, the following procedures will be performed. 
• Eligibility determination: You will be asked to provide documentation of your most recent 
contact lens prescription (e.g., contact lens prescription, contact lens boxes). You will then be 
required to complete a questionnaire to show that your contact lenses are uncomfortable. 
• Questionnaires: Questionnaires will be used to evaluate dry eye, health history, and contact 
lens history. 
• Visual Acuity: Your ability to read the eye chart will be evaluated. 
• Pupil Size: The side of your pupils will be measured with a millimeter ruler. 
• Manifest Refraction: Your glasses prescription will be determined. 
• Anterior Eye Health: Your eye heath will be evaluated with a slit-lamp biomicroscope. 
• Tear Film: The quality of your tears will be evaluated with a topographer (camera) and a 
Phenol Red Thread (a special cotton thread that is placed on the lids to help with the diagnosis 
of dry eyes). 

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• Conjunctival Staining: Your eye’s surface will be evaluated with a non-permanent green dye. 
• Corneal Sensitivity: The sensitivity of your cornea will be evaluated with an esthesiometer (a 
device used to determine corneal sensitivity by adjusting the length of the nylon 
monofilament. 
• Corneal Topography: The curvature of the front of your eye and your iris (colored part of eye) 
will be measured with a topographer (camera). 
• Contact Lens Fitting: You will be fit with orthokeratology contact lenses and daily disposable 
soft contact lenses, which will only be used while you adjust to your orthokeratology contact 
lenses. 
• Contact Lens Evaluation: The fit of your contact lenses will be monitored with a slit-lamp 
biomicroscope (an instrument that uses light and magnification to evaluate the eye) and a 
topographer. 
 
Risks and Discomforts 
 
This study does not involve any inherent discomforts. If you find any of the eye tests 
uncomfortable, you will be allowed to stop participation in the study. There is also a small risk of 
eye infection, which is present with all type of CL (~20/10,000 patient years for overnight use). If 
you develop an eye infection, you will be removed from the study and sent back to your eye care 
provider for treatment and all follow up care. There is also a risk of breach of confidentiality. 
 
Information for Women of Childbearing Potential, Nursing Mothers, and/or Men Capable of 
Fathering a Child 
 
Given hormonal chanes occur during childbearing, which can affect ocular comfort, this study is 
excluding any subjects who are pregnant or nursing at the time of study. 
 
Benefits 
 
You may not benefit directly from taking part in this study. However, you will have the opportunity to 
try orthokeratology contact lenses for free (free CLs that you can keep). Also, knowledge gained from 
this research will help the medical community better understand dry eye disease and if 
orthokeratology contact lenses can be used to avoid contact lens discomfort. 
 
Alternatives 
 
Your alternative is to not participate in this study. There are also possible alternatives to treating 
contact lens discomfort with orthokeratology, which include, but are not limited to daily disposable 
contact lenses, artificial tears/rewetting drops, and prescription dry eye medications. 

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Confidentiality 
 
Information obtained about you for this study will be kept confidential to the extent allowed by law. 
However, research information that identifies you may be shared with people or organizations for 
quality assurance or data analysis, or with those responsible for ensuring compliance with laws and 
regulations related to research. They include: 
• The UAB Institutional Review Board (IRB). An IRB is a group that reviews the study to protect 
the rights and welfare of research participants. 
• Euclid Systems 
• The Food and Drug Administration (FDA) 
• The Office for Human Research Protections (OHRP) 
 
The information from the research may be published for scientific purposes; however, your identity 
will not be given out. Your information may be used for future, undetermined research. 
 
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 website will include 
a summary of the results. You can search this website at any time. 
 
Voluntary Participation and Withdrawal 
 
Whether or not you take part in this study is your choice. There will be no penalty if you decide not to 
be in the study. If you decide not to be in the study, you will not lose any benefits you are otherwise 
owed. 
 
You are free to withdraw from this research study at any time. Your choice to leave the study will not 
affect your relationship with this institution. However, you should return to see the study doctor for 
safety reasons, so you can be taken out of the study contact lenses and referred for follow-up care. 
Contact the study doctor if you want to withdraw from the study. 
 
You may be removed from the study without your consent if the sponsor ends the study, if the study 
doctor decides it is not in the best interest of your health, or if you are not following the study rules. 
 
If you are a UAB student or employee, taking part in this research is not a part of your UAB class work 
or duties. You can refuse to enroll, or withdraw after enrolling at any time before the study is over, 
with no effect on your class standing, grades, or job at UAB. You will not be offered or receive any 
special consideration if you take part in this research. 
 
Cost of Participation 
 
There will be no cost to you for taking part in this study. All materials, exams, and medical care 
related to this study will be provided to you at no cost during the 3-month study period. 

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Payment for Participation in Research 
 
You will be paid $20/visit for a maximum of $120. A check will be mailed to the participant after each 
visit. Subjects will be required to complete the necessary tax document to receive their payments at 
their first visit. 
 
Payment for Research-Related Injuries 
 
UAB and Euclid Systems has not provided for any payment if you are harmed as a result of taking 
part in this study. If such harm occurs, treatment will be provided. However, this treatment will 
not be provided free of charge. 
 
Significant New Findings 
 
You will be told by the study doctor or the study staff if new information becomes available that 
might affect your choice to stay in the study. 
 
Questions 
 
If you have any questions, concerns, or complaints about the research or a research-related injury 
including available treatments, please contact the study doctor. You may contact Dr. Andrew D. 
Pucker at (205) 975-9938 or after hours by emailing him at apucker@uab.edu. 
If you have questions about your rights as a research participant, or concerns or complaints about the 
research, you may contact the UAB Office of the IRB (OIRB) at (205) 934-3789 or toll free at 1-855- 
860-3789. Regular hours for the OIRB are 8:00 a.m. to 5:00 p.m. CT, Monday through Friday. 
 
Legal Rights 
 
You are not waiving any of your legal rights by signing this consent form. 
 
Signatures 
 
Your signature below indicates that you have read (or been read) the information provided above 
and agree to participate in this study. You will receive a copy of this signed consent form. 
 
 
 
Signature of Participant 
Date 
 
 
 
Signature of Person Obtaining Consent 
Date 

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University of Alabama at Birmingham 
AUTHORIZATION FOR USE/DISCLOSURE OF PROTECTED HEALTH INFORMATION (PHI) FOR RESEARCH 
 
Participant Name:    
 
UAB IRB Protocol Number: IRB-300001681 
Research Protocol: Treating Contact Lens Discomfort 
with Orthokeratology 
Principal Investigator: Andrew D. Pucker, OD, PhD 
Sponsor: Euclid Systems 
 
What is the purpose of this form? You are being asked to sign this form so that UAB may use and release your protected 
health information for research. Participation in research is voluntary. If you choose to participate in the research, you 
must sign this form so that your protected health information may be used for the research. 
 
Why do the researchers want my protected health information? The researchers want to use your protected health 
information as part of the research protocol listed above and as described to you in the informed consent. 
 
What protected health information do the researchers want to use? All medical information, including but not limited to 
information and/or records of any diagnosis or treatment of disease or condition, which may include sexually transmitted 
diseases (e.g., HIV, etc.) or communicable diseases, drug/alcohol dependency, etc.; all personal identifiers, including but 
not limited to your name, social security number, medical record number, date of birth, dates of service, etc.; any past, 
present, and future history, examinations, laboratory results, imaging studies and reports and treatments of whatever kind, 
including but not limited to drug/alcohol treatment, psychiatric/psychological treatment; financial/billing information, 
including but not limited to copies of your medical bills, and any other information related to or collected for use in the 
research protocol, regardless of whether the information was collected for research or non-research (e.g., treatment) 
purposes. 
 
Who will disclose, use and/or receive my protected health information? All Individuals/entities listed in the informed 
consent documents, including but not limited to, the physicians, nurses and staff and others performing services related to 
the research (whether at UAB or elsewhere); other operating units of UAB, HSF, UAB Highlands, Children’s of Alabama, Eye 
Foundation Hospital, and the Jefferson County Department of Health, as necessary for their operations; the IRB and its staff; 
the sponsor of the research and its employees and agents, including any CRO; and any outside regulatory agencies, such as 
the Food and Drug Administration, providing oversight or performing other legal and/or regulatory functions for which 
access to participant information is required. 
 
How will my protected health information be protected once it is given to others? Your protected health information that 
is given to the study sponsor will remain private to the extent possible, even though the study sponsor is not required to 
follow the federal privacy laws. However, once your information is given to other organizations that are not required to 
follow federal privacy laws, we cannot assure that the information will remain protected. 
 
How long will this Authorization last? Your authorization for the uses and disclosures described in this Authorization does 
not have an expiration date. 
 
Can I cancel this Authorization? You may cancel this Authorization at any time by notifying the Principal Investigator, in 
writing, referencing the research protocol and IRB Protocol Number. If you cancel this Authorization, the study doctor and 
staff will not use any new health information for research. However, researchers may continue to use the protected health 
information that was provided before you cancelled your authorization. 
 
Can I see my protected health information? You have a right to request to see your protected health information. However, 
to ensure the scientific integrity of the research, you will not be able to review the research information until after the 
research protocol has been completed. 
 
Signature of participant:  
 
Date:   
 
or participant's legally authorized representative:  
 
Date:   
 

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Printed Name of participant’s representative:   
 
Relationship to the participant: