Bilateral Dispensing Study of Fanfilcon A Toric Versus Enfilcon A Toric Lenses

Study Overview
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Brief Summary
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Bilateral dispensing clinical trial of fanfilcon A toric lens verses enfilcon A toric lens over two weeks.

Detailed Description
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Evaluation of the clinical performance of an investigational silicone-hydrogel lens called fanfilcon A (test) compared to a FDA-cleared commercially available contact lens called enfilcon A toric lens (control) when worn on a daily wear basis over 2 weeks in a randomized, bilateral, cross-over, dispensing study.

Official Title
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Bilateral Dispensing Study of Fanfilcon A Toric Versus Enfilcon A Toric Lenses

Conditions
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Myopia, Hyperopia, Astigmatism

Intervention / Treatment
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* Device: fanfilcon A
* Device: enfilcon A


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Are at least 17 years of age for Canada and 18 years of age for the USA and have full legal capacity to volunteer; Have read and signed an information consent letter; Are willing and able to follow instructions and maintain the appointment schedule; Are an adapted soft contact lens wearer; Require spectacle lens powers in both eyes; Sphere: between -0.50 to -6.00 diopters and Astigmatism: between -1.25 to -2.00 and Axis: 180 ± 20 degrees Are willing to wear contact lens in both eyes; Have manifest refraction visual acuities (VA) equal to or better than logMAR equivalent of 20/25 in each eye; To be eligible for lens dispensing, the subject must have VA of logMAR equivalent of 20/30 or better in each eye with the study lenses and the investigator must judge the fit including toric orientation as acceptable; Exclusion Criteria: Are participating in any concurrent clinical or research study; Have any known active* ocular disease and/or infection; Have a systemic condition that in the opinion of the investigator may affect a study outcome variable; Are using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable; Have known sensitivity to the diagnostic pharmaceuticals to be used in the study; Are pregnant, lactating or planning a pregnancy at the time of enrolment (by verbal confirmation at the screening visit); Are aphakic; Have undergone refractive error surgery;

Ages Eligible for Study
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Minimum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: fanfilcon A<br>Each subject randomized to wear either the test or control as a matched pair and cross over to the second matched pair. | Device: fanfilcon A<br>* contact lens<br>Device: enfilcon A<br>* contact lens<br>|
| Active Comparator: enfilcon A<br>Each subject randomized to wear either the test or control as a matched pair and cross over to the second matched pair. | Device: fanfilcon A<br>* contact lens<br>Device: enfilcon A<br>* contact lens<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comfort (Subjective Rating Scale) | Participant rating for comfort at dispense visit and at the 2 week follow-up on a subjective rating scale (0-100, 0=cannot be worn. Causes pain,100=Cannot be felt ever) | Dispensing (Baseline) and 2 weeks | 
| Comfort Preference | Subjective assessment for comfort preference for each lens pair. Choices: fanfilcon A lens, enfilcon A lens, No preference. | Dispensing (Baseline) and 2 weeks |