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

CooperVision

Status: Completed

Conditions: Myopia; Hyperopia

Treatments: Device: Lens A (fanfilcon A); Device: Lens B (lotrafilcon B)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06098339

EX-MKTG-151

Details and patient eligibility

About

The purpose of this study was to compare the clinical performance of two different reusable lenses in habitual spherical soft lens wearers.

Full 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.

Enrollment: 53 patients

Sex: All

Ages: 18 to 39 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Were at least 18 years of age and no older than 39 years, and had full legal capacity to volunteer;

2. Had read and signed an information consent letter;

3. Were willing and able to follow instructions and maintain the appointment schedule;

4. Self-reported having had a full eye examination in the previous two years;

5. Had healthy eyes with no health condition or medication that contra-indicate contact lens wear, in the opinion of the investigator;

6. Anticipated being able to wear the study lenses for at least 8 hours a day, 6 days a week;

7. 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;

8. Had refractive astigmatism no higher than -0.75DC in each eye;

9. 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

1. Were participating in any concurrent clinical or research study;
2. Had any known active ocular disease and/or infection that contraindicated contact lens wear;
3. Had a systemic or ocular condition that in the opinion of the investigator may have affected a study outcome variable;
4. 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;
5. Had known sensitivity to the diagnostic sodium fluorescein used in the study;
6. Self-reported as pregnant, lactating or planning a pregnancy at the time of enrolment;
7. Had undergone refractive error surgery or intraocular surgery.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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53 participants in 2 patient groups

Lens A, then Lens B

Experimental group

Description:

Participants wore Lens A for one month and then Lens B for one month.

Treatment:

Device: Lens B (lotrafilcon B)

Device: Lens A (fanfilcon A)

Lens B, then Lens A

Experimental group

Description:

Participants wore Lens B one month and then Lens A for one month.

Treatment:

Device: Lens B (lotrafilcon B)

Device: Lens A (fanfilcon A)