Pilot Evaluation of a New Galyfilcon A Lens Prototype and Enfilcon A Lens

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the visual acuity, limbal and bulbar redness of the new galyfilcon A prototype lenses against Avaira® lenses when worn as daily wear for seven (7) days.

Official Title
-----------------
Dispensing Evaluation of a New Galyfilcon A Prototype and Avaira Lenses

Conditions
-----------------
Myopia

Intervention / Treatment
-----------------
* Device: galyfilcon A prototype lens
* Device: enfilcon A lens


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The subject is a current spherical soft contact lens wearer and willing to wear the study lenses on a daily wear basis for the duration of the study. The subject's optimal vertexed spherical equivalent distance correction must be between -1.00 and - 5.00D. Any cylinder power must be ≤ -0.75D. The subject must have visual acuity best correctable to 20/25+3 or better for each eye. The subject must read and sign the Statement of Informed Consent. The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol. Exclusion Criteria: Ocular or systemic allergies or disease which might interfere with contact lens wear. Systemic disease or use of medication which might interfere with contact lens wear. Clinically significant (grade 3 or 4) corneal edema, corneal vascularization, corneal staining, or any other abnormalities of the cornea which would contraindicate contact lens wear. Clinically significant (grade 3 or 4) tarsal abnormalities or bulbar injection which might interfere with contact lens wear. Any ocular infection. Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear. Pregnancy or lactation. Diabetes. Infectious diseases (e.g. hepatitis, tuberculosis) or an immuno-suppressive disease (e.g. HIV). Habitual contact lens type is toric, multifocal, or is worn as extended wear.

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: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: galyfilcon A prototype lens/enfilcon A lens<br>galyfilcon A prototype contact lens worn daily for 6-8 days first then enfilcon A contact lens worn daily for 6-8 days second. | Device: galyfilcon A prototype lens<br>* Prototype silicone hydrogel contact lens<br>Device: enfilcon A lens<br>* Marketed silicone hydrogel contact lens<br>* Other names: Avaira® contact lens;|
| Other: enfilcon A lens/galyfilcon A prototype lens<br>enfilcon A contact lens worn daily for 6-8 days first then galyfilcon A prototype contact lens worn daily for 6-8 days second. | Device: galyfilcon A prototype lens<br>* Prototype silicone hydrogel contact lens<br>Device: enfilcon A lens<br>* Marketed silicone hydrogel contact lens<br>* Other names: Avaira® contact lens;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Monocular Visual Acuity Assessment | Snellen monocular visual acutity (VA) assessed by the Investigator and was converted to the LogMAR scale. | Post lens insertion (baseline) | 
| Binocular Visual Acuity | Snellen binocular visual acuity assessed by the Investigator and was converted to the LogMAR scale. A value <0 implies clinically positive results, a value >0 implies clinically negative results | Post lens insertion (baseline) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Limbal Redness of Grade 3 or Above | Limbal redness was assessed using a 5-point slit lamp classification scale (5-Worst, 0-None). Only those eyes with limbal redness grade >= 3 were reported for purposes of this analysis. Grades 3 -5 are considered to be part of the adverse events reporting. | After 6-8 days of lens wear | 
| Bulbar Redness of Grade 3 or Above | Bulbar redness was assessed using a 5-point slit lamp classification scale (5-Worst, 0-None). Only those eyes with bulbar redness grade >= 3 were reported for purposes of this analysis. Grades 3 -5 are considered to be part of the adverse events reporting. | After 6-8 days of lens wear |