Dispensing Evaluation of Printed Etafilcon A With Polyvinylpyrrolidone (PVP)

Completed · Not applicable

Conditions studied: Myopia

In brief

The purpose of this study is to evaluate the lens fit (mechanical and cosmetic lens fit) of the printed etafilcon A with polyvinylpyrrolidone (PVP).

Key facts

Study ID

NCT01180777

Run by

Johnson & Johnson Vision Care, Inc.

People needed

95

Starts

2010-07-01

Expected to finish

2010-08-01

Last updated by the study team

2018-06-19

Who can join

Age: 18 and older, up to 40. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• The subject must be at least 18 years of age and less than 40 years of age.
• The subject must be a light eye Caucasian female habitual soft contact lens wearer.
• The subject must be concept acceptors for cosmetic and/or limbal ring lenses. A concept screening questionnaire will be used and top 3 box (in 5-point scale) is eligible.
• The subject must have no known ocular or systemic allergies that might interfere with contact lens wear.
• The subject must have no known systemic disease, or need for medication, which might interfere with contact lens wear.
• 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 have normal eyes (no ocular medications or ocular infection of any type).
• 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 worse) 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.
• Any color deficiencies - to the best of the subject's knowledge.
• 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 — Cupertino, California, United States
• Study site — Los Angeles, California, United States
• Study site — San Jose, California, United States
• Study site — Jacksonville, Florida, United States
• Study site — Jacksonville, Florida, United States
• Study site — Orlando, Florida, United States

Full record on ClinicalTrials.gov

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