Pilot Evaluation of a New Galyfilcon A Lens Prototype and Enfilcon A Lens
Completed · Not applicable
Conditions studied: Myopia
In brief
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.
Key facts
- Study ID
- NCT01192542
- Run by
- Johnson & Johnson Vision Care, Inc.
- People needed
- 39
- Starts
- 2010-08-01
- Last updated by the study team
- 2018-06-19
Who can join
Age: 18 and older, up to 39. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Study site — Pismo Beach, California, United States
- Study site — Warwick, Rhode Island, United States
- Study site — Fincastle, Virginia, United States
Full record on ClinicalTrials.gov
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