Pilot Evaluation of a New Galyfilcon A Lens Prototype and Enfilcon A Lens
Status: | Completed |
---|---|
Conditions: | Ocular |
Therapuetic Areas: | Ophthalmology |
Healthy: | No |
Age Range: | 18 - 39 |
Updated: | 6/21/2018 |
Start Date: | August 2010 |
Dispensing Evaluation of a New Galyfilcon A Prototype and Avaira Lenses
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.
new galyfilcon A prototype lenses against Avaira® lenses when worn as daily wear for seven
(7) days.
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.
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