Performance Evaluation of Reusable Contact Lenses When Worn For One Month By Habitual Soft Contact Lens Wearers

Coopervision, Inc.3 sites in 2 countries53 target enrollmentNovember 13, 2023

ConditionsMyopia Hyperopia

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Myopia
Sponsor: Coopervision, Inc.
Enrollment: 53
Locations: 3
Primary Endpoint: Lens Handling on Removal
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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 participant was approximately 3 months.

Registry

clinicaltrials.gov

Start Date

November 13, 2023

End Date

April 4, 2024

Last Updated

last year

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Coopervision, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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;

Exclusion Criteria

•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.

Outcomes

Primary Outcomes

Lens Handling on Removal

Time Frame: Day 27

Participants measured subjective lens handling at removal on a 0-100 integer scale, where 0=worst and 100=best. Results for each lens were collected in the at-home diary on Day 27.