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Dispensing Evaluation of Printed Etafilcon A With Polyvinylpyrrolidone (PVP)

CompletedNA

Sponsor: Johnson & Johnson Vision Care, Inc.

Conditions: Myopia

Interventions: etafilcon A (A), etafilcon A (B), etafilcon A (C)

Countries: United States

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

Eligibility overview

Sex: FEMALE

Age: 18 Years to 40 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

1. The subject must be at least 18 years of age and less than 40 years of age.
2. The subject must be a light eye Caucasian female habitual soft contact lens wearer.
3. 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.
4. The subject must have no known ocular or systemic allergies that might interfere with contact lens wear.
5. The subject must have no known systemic disease, or need for medication, which might interfere with contact lens wear.
6. The subject's optimal vertexed spherical equivalent distance correction must be between -1.00 and - 5.00D.
7. Any cylinder power must be ≤ -0.75D.
8. The subject must have visual acuity best correctable to 20/25+3 or better for each eye.
9. The subject must have normal eyes (no ocular medications or ocular infection of any type).
10. The subject must read and sign the Statement of Informed Consent.
11. The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.

Exclusion Criteria:

1. Ocular or systemic allergies or disease which might interfere with contact lens wear.
2. Systemic disease or use of medication which might interfere with contact lens wear.
3. 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.
4. Clinically significant (grade 3 or 4) tarsal abnormalities or bulbar injection which might interfere with contact lens wear.
5. Any ocular infection.
6. Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
7. Any color deficiencies - to the best of the subject's knowledge.
8. Pregnancy or lactation.
9. Diabetes.
10. Infectious diseases (e.g. hepatitis, tuberculosis) or an immuno-suppressive disease (e.g. HIV).
11. Habitual contact lens type is toric, multifocal, or is worn as extended wear.

Locations (6)

Cupertino, California, United States
Los Angeles, California, United States
San Jose, California, United States
Jacksonville, Florida, United States
Jacksonville, Florida, United States
Orlando, Florida, United States