Performance Evaluation of Reusable Contact Lenses When Worn For One Month By Habitual Soft Contact Lens Wearers
Completed · Not applicable
Conditions studied: Myopia, Hyperopia
In brief
The purpose of this study was to compare the clinical performance of two different reusable lenses in habitual spherical soft lens wearers.
Key facts
- Study ID
- NCT06098339
- Run by
- CooperVision, Inc.
- People needed
- 53
- Starts
- 2023-11-13
- Expected to finish
- 2024-04-04
- Last updated by the study team
- 2024-08-28
Who can join
Age: 18 and older, up to 39. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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).
You may not qualify if…
- 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.
Where it is running
- Coan Eye Care — Ocoee, Florida, United States
- Nittany Eye Associates — State College, Pennsylvania, United States
- Insight Eye Care — Waterloo, Ontario, Canada
Full record on ClinicalTrials.gov
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