Evaluation of Wear Experience With PRECISION1® Contact Lenses in Previous Acuvue® Oasys® Lens Wearers
Phase: NA
Conditions: Contact Lens
Sponsor: Ohio State University

 
 
 
 
 
 
 
 
Evaluation of Wear Experience with a Daily Disposable 
Contact Lens 
 
NCT04296877  
Version dated 25Jun2020 
 

 
 
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Evaluation of Wear Experience with a Daily Disposable Contact Lens  
Jennifer Fogt, OD MS 
The Ohio State University College of Optometry 
Innovation in Vision and Eye care Research Group - iVERG 
338 West 10th Ave 
Columbus OH 43210 
 
 
Purpose 
The purpose of this study is to explore the wear experience of current reusable lens wearers after they 
have been fit into daily disposable contact lenses.   
 
Study Overview 
This open-label study is of current Acuvue® Oasys® wearers who are satisfied with their current lenses.  
Subjects will be refit into PRECISION1® contact lenses and will wear lenses for approximately 2 weeks.  
Subjects will return for vision and lens fit assessments and will complete surveys about their wear 
experience. 
 
Background 
Soft daily wear contact lenses are used by an estimated 40.9 million adults in the United States.1  Contact 
lenses which are worn for daily wear are considered minimal risk by the FDA, and risks to wearers are 
minimized by proper lens care and hygiene. Daily disposable contact lenses do not require daily cleaning 
and overnight storage, which improves the required amount of time to care for contact lenses.  In 
addition, daily disposable contact lenses are associated with less lens deposits, which decreases 
associated comfort issues in lens wearers, including decreasing the risk of triggering Giant papillary 
conjunctivitis (GPC) and/or ocular allergic responses in patients.2  Additionally, daily disposable contact 
lens wearers are not likely to expose their lenses to water and tend to have better lens hygiene since these 
lenses do not require daily cleaning.  This is reflected in a study which found less superficial punctate 
staining and symptoms of dryness when comparing daily disposable contact lens wear with planned 
replacement lenses.3   The subjects in this study are current satisfied wearers of 2 week planned 
replacement lenses (Acuvue® Oasys®) and will be fit into PRECISION1 daily disposable contact lenses, 
which are less likely to be associated with the already minimal risks of daily contact lens wear. 
 
 
Key Endpoints: 
• 
Subjective assessment of P1 with CLDEQ-8  

 
 
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• 
Visual Analog Scale survey of lens wear symptoms (comfort, dryness, vision) 
• 
Assessment via questionnaire about quality of life, preference, and lens modality experience 
 
Study Time Points: 
A screening visit will be conducted to consent the subject and determine eligibility.  Subjects should report 
to the exam wearing existing current Acuvue® Oasys® lenses with a copy of their current prescription or 
packaging.   Visual acuity and an evaluation of the subject’s ocular health will occur to determine eligibility 
including positively responding to the question, “Are you satisfied with your current Acuvue Oasys contact 
lenses?”  Acuvue Oasys lenses will be evaluated and optimized before dispensing a new pair of lenses for 
1 week of wear. 
In light of The Ohio State University Office of Responsible Research requirements to halt research due to 
COVID-19, all enrolled subjects may continue to wear the lenses dispensed for the normal two weeks of 
daily wear as prescribed. Beyond this two week replacement schedule, subjects may resume their normal 
contact lens routine. Subjects will be contacted to resume the study when permissible by The Ohio State 
University. Once the study resumes, patients can be dispensed an additional pair of study lenses to wear 
for one week before their scheduled Visit 2.   
Visit 2: Acuvue Oasys contact lens follow up and Precision 1 fitting visit.  Patients will be asked if they 
are still satisfied with their current Acuvue® Oasys® contact lenses in order to proceed and vision, lens fit 
and ocular health will be assessed.  Subjects will then be fit with PRECISION1® Contact Lenses with 
assessments of initial satisfaction, initial comfort, and initial vision.  Lenses will be dispensed and a contact 
lens follow-up visit will be scheduled. 
Visit 3: The contact lens follow up visit will occur approximately 2 weeks (±3 days) following the initial 
fitting.  Subjects will have visual acuity, an assessment of ocular health, and lens fit completed.  Subjects 
will then complete surveys about their lens wear experience. 
 
 
Surveys (which will be deployed and completed in REDCap) will include:  
CLDEQ-8  
VAS survey of comfort/dryness/vision 
0-100 scale:  
Overall Quality of vision 
End of Day Quality of vision  
Overall comfort 
End of Day comfort 
Overall dryness  
End of Day dryness 
Quality of life/preference, lens modality experience 
Convenience of daily disposable, preference for daily disposable, ease of use 
 
Recruitment 

 
 
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Potential subjects may see posters placed on bulletin boards at The Ohio State University or local eye care 
offices, emails to students, faculty and staff at OSU, online or paper ads, or signs on the OSU buses.  A 
search of the electronic medical records of The Ohio State College of Optometry and of individuals who 
participate in the Optometry Recruitment Database may be done to identify possible subjects who then 
may be contacted by email or phone with information about the study. Word of mouth referrals by study 
team members to OSU employees and friends may occur.  Emails to alumni of the OSU College of 
Optometry may be sent for local doctors to notify eligible potential subjects about the study. The use of 
ResearchMatch.org may also be requested as a recruitment method.  
 
Inclusion criteria:  
• 
Subjects must be current Acuvue® Oasys® spherical lens wearers.    
• 
Subjects must have 20/25 or better distance visual acuity with current lenses. 
• 
Good general health (defined by medication use that has not changed within the last 
month and the absence of medical conditions or treatments that are deemed 
confounding to the data as determined by the PI) 
• 
Ability to give informed consent  
• 
Willing to spend time for the study.  Subjects will be required to attend two study visits 
and wear contact lenses on days between study visits.   
• 
Either gender 
• 
Any racial or ethnic origin 
Exclusion criteria:  
• 
No current ocular inflammation or infection as assessed by the study investigator 
 
Consent and Confidentiality 
Informed consent will be conducted using REDCap.  A team member trained in the consent process will 
provide the consent document for the potential subject to read and will review the procedures with 
reference to the consent form. The individual is then provided with time to read the consent form and 
offered the opportunity to ask questions. The participant is explicitly told that they may stop participation 
at any time. All subjects will have the capacity to give informed consent. If there is any doubt as to the 
subject’s ability to consent to the study, the subject will be excluded from the study. If the subject agrees 
to take part in the screening or measurement, he or she will sign and date the most recent IRB approved 
consent form in REDCap.  The subject will be able to save a copy or print a copy of the document to keep 
for their records.   A team member will also sign the informed consent document in the REDCap system. 
The investigator team is trained in privacy issues and will be reminded of the importance of patient privacy 
prior to study initiation. Potential study participants will contact us after seeing advertisements, emails or 
hearing about the study by word of mouth, giving them the choice of whether or not they wish to 
participate in a study for people with dry eyes.  Privacy is protected by limiting information related to 
study recruitment only, and no other personal or medical information that should be private to the 
patients. The PHI needed is only for the purposes of this study. It is highly unlikely, indeed extremely 
remote that the dry eye symptoms or signs are related to private or personal information that should or 

 
 
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would be preferred to be kept confidential to the patients. Risk factors for dry eye rarely relate to matters 
or conditions that would be personal to the patient such as personal relationships, behaviors or diseases 
that one prefers to keep private and confidential. 
 
Statistical Analysis and Power Calculation 
This small sample size was chosen for convenience as this study is not intending to prove superiority, but 
to study the acceptability of the study lens in previous successful Acuvue® Oasys® wearers.  
Statistical analysis will be reported with descriptive statistics as this is not a comparative study. 
 
Data Management and Security 
During the active stages of the study (recruitment to last measurement visit), all paperwork (consents, 
questionnaires and data forms) for each subject will reside in a subject folder for easy access throughout 
the study. The folders will reside in the limited-access research area, in a locked file drawer or cupboard. 
At the completion of the study or disenrollment of a subject the paperwork in the subject’s folders will be 
reorganized into a regulatory binder (consents, W-9s) and a data binder (questionnaire and data forms) 
and will reside in an office in the limited-access research area. When the data analysis is completed and 
the study is considered complete, the binders will be stored in the secure Department or Office Clinical 
Research Area. Paperwork (questionnaire and data forms) for individuals who participate in the baseline 
visit but are not eligible to continue the study will be stored in the study regulatory binder in an office in 
the limited-access research area. An electronic file of potential subjects and a file of enrolled subjects with 
their contact information, as well as electronic files of collected data with the subject number, will reside 
on a limited-access shared drive with firewall and password protection and is restricted to individuals in 
the research team. Any electronic data files that contain PHI will be destroyed at the conclusion of the 
study. 
 
Risks to Subjects and Mitigation 
Although rare, a subject could experience eye pain, changes in vision, continued redness or irritation of 
the eye when inserting or learning to insert a contact lens. More likely transient blurring of vision (less 
than one minute) or mild, transient (less than a minute) stinging may occur. 
 
Adverse Events 
All adverse events will be documented and reported under the guidelines of The Ohio State University 
Event Reporting guidelines, with any serious, unanticipated and related events being reported to the IRB, 
by the PI, within 10 days. Adverse Events information will be summarized in the annual report to the IRB 
at the end of the study.  Adverse events will be assessed and determined by Dr. Jennifer Fogt.  
 
Subject Dismissal  

 
 
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Subjects who, after study team member coaching, are not able to provide analyzable data may be 
dismissed from the study. Analyzable data is, for example, that which is obtained for the entire 
measurement interval and provides a readable eye image. Data may not be analyzable if patient isn’t able 
to stand or move freely to utilize the equipment, to name just two causes issues. These issues are usually 
revealed at the screening assessment visit. Subjects who cannot provide analyzable data will be dismissed 
for the study. Subjects who do not keep scheduled visits within the required time frame will be dismissed 
from the study. Study team members will make reasonable efforts to accommodate subjects’ schedules.  
 
Protocol Violations, Discontinuation  
In the event that a member of the study team or a representative of sponsor becomes aware of a major 
protocol violation, the IRB shall be notified within 10 working days.   
 
Timeline 
IRB submission and approval      Recruitment and Data collection         Data processing and analysis        Final report  
        6-8 weeks   
 
               Months 3-4  
       
 
 Month 5  
    
    Month 6 
               
 
Depending on the time of year that this project can begin, an abstract is likely to be submitted to ARVO and AAO 
with others possible as submission timing arises.   There are large amounts of data collected in this study, giving a 
lot of possible topics for abstracts and publication, making it likely that more than two abstracts could be submitted.   
A final publication will be written and submitted to Cornea, Contact Lens and Anterior Eye, Clinical Ophthalmology 
or another journal focusing on anterior segment of the eye.  
 
 
 
References 
 
1. 
Arita R, Mori N, Shirakawa R, et al. Meibum Color and Free Fatty Acid Composition in Patients 
With Meibomian Gland Dysfunction. Invest Ophthalmol Vis Sci. 2015;56(8):4403-4412. 
2. 
Hickson-Curran S, Spyridon M, Hunt C, Young G. The use of daily disposable lenses in problematic 
reusable contact lens wearers. Cont Lens Anterior Eye. 2014;37(4):285-291. 
3. 
Ichijima H, Karino S, Sakata H, Cavanagh HD. Improvement of Subjective Symptoms and Eye 
Complications When Changing From 2-Week Frequent Replacement to Daily Disposable Contact 
Lenses in a Subscriber Membership System. Eye Contact Lens. 2016;42(3):190-195.