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

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the clinical performance of two different monthly replacement lens in habitual spherical soft lens wearers.

Detailed Description
-----------------
This study is 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 is approximately 3 months.

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

Conditions
-----------------
Myopia, Hyperopia

Intervention / Treatment
-----------------
* Device: Lens A (fanfilcon A)
* Device: Lens B (lotrafilcon B)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Is at least 18 years of age and no older than 39 years, and has full legal capacity to volunteer; Has read and signed an information consent letter; Is willing and able to follow instructions and maintain the appointment schedule; Self-reports having a full eye examination in the previous two years; Has healthy eyes with no health condition or medication that contra-indicate contact lens wear, in the opinion of the investigator; Anticipates being able to wear the study lenses for at least 8 hours a day, 6 days a week; Habitually wears spherical soft contact lenses, for the past 3 months minimum: It is preferred that all participants are habitual frequent replacement lens wearers. However, if this is not possible then no more than 5 participants can be habitual daily disposable lens wearers at each site, the rest must be habitual frequent replacement lens wearers; - For the frequent replacement wearers: No more than 3 can be habitual wearers of the Avaira Vitality™/ Serenity™ brand (or their equivalent private label brand name) and no more than 3 can be habitual wearers of AIR OPTIX® plus HydraGlyde® can be enrolled at each site; Has refractive astigmatism no higher than -0.75DC in each eye; Can 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: Is participating in any concurrent clinical or research study; Has any known active ocular disease and/or infection that contraindicates contact lens wear; Has a systemic or ocular condition that in the opinion of the investigator may affect a study outcome variable; Is using any systemic or topical medications that in the opinion of the investigator may affect contact lens wear or a study outcome variable; Has known sensitivity to the diagnostic sodium fluorescein used in the study; Self-reports as pregnant, lactating or planning a pregnancy at the time of enrolment; Has undergone refractive error surgery or intraocular surgery.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 39 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lens A, then Lens B<br>Participants will wear Lens A for one month and then wear Lens B for one month. | Device: Lens A (fanfilcon A)<br>* Daily wear for one month<br>Device: Lens B (lotrafilcon B)<br>* Daily wear for one month<br>|
| Experimental: Lens B, then Lens A<br>Participants will wear Lens B one month and then wear Lens A for one month. | Device: Lens A (fanfilcon A)<br>* Daily wear for one month<br>Device: Lens B (lotrafilcon B)<br>* Daily wear for one month<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lens Handling on Removal | Participants will measure subjective lens handling at removal on a 0-100 integer scale, where 0=worst and 100=best. Results for each lens will be collected in the at-home diary on Day 27. | Day 27 |