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

Not Applicable

Completed

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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
enfilcon A lens/galyfilcon A prototype lens	enfilcon A lens	enfilcon A contact lens worn daily for 6-8 days first then galyfilcon A prototype contact lens worn daily for 6-8 days second.
galyfilcon A prototype lens/enfilcon A lens	enfilcon A lens	galyfilcon A prototype contact lens worn daily for 6-8 days first then enfilcon A contact lens worn daily for 6-8 days second.
enfilcon A lens/galyfilcon A prototype lens	galyfilcon A prototype lens	enfilcon A contact lens worn daily for 6-8 days first then galyfilcon A prototype contact lens worn daily for 6-8 days second.
galyfilcon A prototype lens/enfilcon A lens	galyfilcon A prototype lens	galyfilcon A prototype contact lens worn daily for 6-8 days first then enfilcon A contact lens worn daily for 6-8 days second.

Primary Outcome Measures

Name	Time	Method
Monocular Visual Acuity Assessment	Post lens insertion (baseline)	Snellen monocular visual acutity (VA) assessed by the Investigator and was converted to the LogMAR scale.
Binocular Visual Acuity	Post lens insertion (baseline)	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

Secondary Outcome Measures

Name	Time	Method
Bulbar Redness of Grade 3 or Above	After 6-8 days of lens wear	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.
Limbal Redness of Grade 3 or Above	After 6-8 days of lens wear	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.