Evaluation of Wear Experience With PRECISION7® Contact Lenses in Habitual Acuvue® Oasys® Lens Wearers
Phase: NA
Conditions: Myopia
Sponsor: Ohio State University

IRB Approved: 16 Apr 2024 
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Evaluation of Wear Experience with PRECISION7® Contact lenses in habitual 
Acuvue® Oasys® lens wearers 
Protocol Number: 2024H0089 
NCT Number: NCT06382064 
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16 Apr 2024 
 
 
 
 
 
 
 
 
 
 

IRB Approved: 16 Apr 2024 
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Evaluation of Wear Experience with PRECISION7® Contact lenses in habitual 
Acuvue® Oasys® lens wearers 
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 
Phone:  614-292-0882 
 
 
Purpose 
The purpose of this study is to explore the wear experience of current Acuvue Oasys lens wearers after 
they have been fit into PRECISION7® Contact Lenses.  
Study Overview 
This open-label study is of current Acuvue® Oasys® wearers (2 – week replacement, reusable lenses) who 
are satisfied with their current lenses.  Subjects will be refit into PRECISION7® 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. The subjects in this study are current satisfied wearers of 2 
week planned replacement lenses (Acuvue® Oasys®) and will be fit into PRECISION7® 1 week reusable 
contact lenses. 
 
Key Endpoint: 
• 
Subjective assessment of P7 experience with CLDEQ-8  
Exploratory Endpoints: 
• 
Visual Analog Scale survey of lens wear symptoms (comfort, dryness, vision, satisfaction) 
• 
Assessment via questionnaire about quality of life, preference, and lens modality experience 
 
 
 
Study Time Points: 

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After responding to recruitment material, potential participants will respond to pre-screening questions 
to determine initial eligibility.  Those eligible will be scheduled for a screening visit and will complete the 
informed consent process.  Participants 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 2 weeks of wear (-3 days). 
Assessments of initial satisfaction, initial comfort, and initial vision will also be complete. 
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 PRECISION7® 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 for 2 weeks (-3 days) 
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. 
 
 
All surveys will be completed in REDCap.2,3 
Surveys will include:  
CLDEQ-8  
Initial impression VAS surveys 
 
Initial vision 
 
Initial comfort 
 
Initial satisfaction 
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 
Overall satisfaction 
End of Study Wear Experience 
Convenience of 1 week replacement lens, preference for 1 week replacement lens, ease  
of use 
Would you purchase/switch to P7? 
Satisfaction with P7 
Quality of Life 
Quality of vision while watching television, using your smart phone, dining out, working  
out, reading a book/magazine/newspaper 
Comfort while watching television, using your smart phone, dining out, working  

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out, reading a book/magazine/newspaper 
 
 
 
Recruitment 
Potential subjects may see posters placed on bulletin boards locally, at The Ohio State University, or local 
eye care offices, student dorms, emails to students, faculty and staff at OSU, online or paper ads, or signs 
on the OSU buses. Facebook advertising through the CCTS will occur. A search of the electronic medical 
records of The Ohio State College of Optometry 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. 
 
Inclusion criteria:  
 
Subjects must be current Acuvue® Oasys® spherical lens wearers.    
 
Subjects must have 20/25 or better distance visual acuity with current lenses in each eye. 
 
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 three study visits 
and wear contact lenses on days between study visits.   
 
Either gender 
 
Any racial or ethnic origin 
Exclusion criteria:  
 
Current ocular inflammation or infection as assessed by the study investigator 
 
Currently pregnant or lactating.  
 
Systemic inflammatory disease (i.e. Diabetes, etc.) that could confound study results in 
the opinion of the investigator 
 
Consent and Confidentiality 
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-stamped consent as will the team member. The subject will be 
provided with a copy of the consent form. 

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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 
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  
This pilot study was not intended (powered) to prove superiority, but to study the acceptability of the 
study lens in previous successful Acuvue® Oasys® wearers.  The study reported outcomes using descriptive 
statistics, and as such, no power calculation was necessary. Several contact lens studies have been 
conducted at this site which successfully recruited 50 participants. Eighty potential participants will be 
screened in order to complete 60 participants. 
 
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. 

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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  
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.   
 
 
 
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 Morb Mortal Wkly Rep. 
2015;64(32):865-870. 
2. 
Harris PA, Taylor R, Minor BL, et al. The REDCap consortium: Building an international community 
of software platform partners. J Biomed Inform. 2019;95:103208. 
3. 
Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture 
(REDCap)-A metadata-driven methodology and workflow process for providing translational 
research informatics support. J Biomed Inform. 2009;42(2):377-381.