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

Not Applicable

Completed

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.

Recruitment & Eligibility

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;
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 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.

Arm && Interventions

Group	Intervention	Description
Lens A, then Lens B	Lens A (fanfilcon A)	Participants wore Lens A for one month and then Lens B for one month.
Lens A, then Lens B	Lens B (lotrafilcon B)	Participants wore Lens A for one month and then Lens B for one month.
Lens B, then Lens A	Lens A (fanfilcon A)	Participants wore Lens B one month and then Lens A for one month.
Lens B, then Lens A	Lens B (lotrafilcon B)	Participants wore Lens B one month and then Lens A for one month.

Primary Outcome Measures

Name	Time	Method
Lens Handling on Removal	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.

Secondary Outcome Measures

Name	Time	Method

Locations (3): Coan Eye Care
🇺🇸
Ocoee, Florida, United States
Insight Eye Care
🇨🇦
Waterloo, Ontario, Canada
Nittany Eye Associates
🇺🇸
State College, Pennsylvania, United States