Status:
COMPLETED
Dispensing Evaluation of Printed Etafilcon A With Polyvinylpyrrolidone (PVP)
Lead Sponsor:
Johnson & Johnson Vision Care, Inc.
Conditions:
Myopia
Eligibility:
FEMALE
18-40 years
Phase:
NA
Brief Summary
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 Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2010
Estimated Enrollment :
95 Patients enrolled
Trial Details
Trial ID
NCT01180777
Start Date
July 1 2010
End Date
August 1 2010
Last Update
June 19 2018
Active Locations (6)
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1
Cupertino, California, United States, 95014
2
Los Angeles, California, United States, 90049
3
San Jose, California, United States, 95131
4
Jacksonville, Florida, United States, 32205