Status:
COMPLETED
Performance Evaluation of Reusable Contact Lenses When Worn For One Month By Habitual Soft Contact Lens Wearers
Lead Sponsor:
CooperVision, Inc.
Collaborating Sponsors:
Centre for Ocular Research & Education, Canada
Conditions:
Myopia
Hyperopia
Eligibility:
All Genders
18-39 years
Phase:
NA
Brief Summary
The purpose of this study was to compare the clinical performance of two different reusable lenses in habitual spherical soft lens wearers.
Detailed Description
This study was a prospective, bilateral eye, double-masked, randomized, 1 month cross-over, daily-wear design involving two different frequent replacement type lenses. Duration of involvement for each...
Eligibility Criteria
Inclusion
- Were at least 18 years of age and no older than 39 years, and had full legal capacity to volunteer;
- Had read and signed an information consent letter;
- Were willing and able to follow instructions and maintain the appointment schedule;
- Self-reported having had a full eye examination in the previous two years;
- Had healthy eyes with no health condition or medication that contra-indicate contact lens wear, in the opinion of the investigator;
- Anticipated being able to wear the study lenses for at least 8 hours a day, 6 days a week;
- Habitually wore spherical soft contact lenses, for the past 3 months minimum:
- It was preferred that all participants were habitual frequent replacement lens wearers. However, if this was not possible then no more than 5 participants could be habitual daily disposable lens wearers at each site, the rest had to be habitual frequent replacement lens wearers;
- \- For the frequent replacement wearers: No more than 3 could be habitual wearers of the Avaira Vitality™/ Serenity™ brand (or their equivalent private label brand name) and no more than 3 could be habitual wearers of AIR OPTIX® plus HydraGlyde® can be enrolled at each site;
- Had refractive astigmatism no higher than -0.75DC in each eye;
- Could be fit and achieve binocular distance vision of at least 20/30 Snellen (Available lens parameters are sphere +6.00 to -6.00D, 0.25D steps).
Exclusion
- Were participating in any concurrent clinical or research study;
- Had any known active ocular disease and/or infection that contraindicated contact lens wear;
- Had a systemic or ocular condition that in the opinion of the investigator may have affected a study outcome variable;
- Were using any systemic or topical medications that in the opinion of the investigator may have affect contact lens wear or a study outcome variable;
- Had known sensitivity to the diagnostic sodium fluorescein used in the study;
- Self-reported as pregnant, lactating or planning a pregnancy at the time of enrolment;
- Had undergone refractive error surgery or intraocular surgery.
Key Trial Info
Start Date :
November 13 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 4 2024
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT06098339
Start Date
November 13 2023
End Date
April 4 2024
Last Update
August 28 2024
Active Locations (3)
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1
Coan Eye Care
Ocoee, Florida, United States, 34761
2
Nittany Eye Associates
State College, Pennsylvania, United States, 16801
3
Insight Eye Care
Waterloo, Ontario, Canada, N2L 3S1