Clinical trial NCT01180777: Dispensing Evaluation of Printed Etafilcon A With Polyvinylpyrrolidone (PVP)
Official title: Dispensing Evaluation of Printed Etafilcon A With Polyvinylpyrrolidone (PVP) Contact Lenses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Lead sponsor: Johnson & Johnson Vision Care, Inc.
Sponsor class: INDUSTRY
First posted: 2010-08-12
Enrollment: 95
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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 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.

Primary outcomes:
measure: Lens Fit Acceptance
timeFrame: 10-15 minutes post lens fit
Secondary outcomes:
measure: Binocular Snellen Visual Acuity (VA)
timeFrame: 10-15 minutes post lens fit
measure: Corneal Staining
timeFrame: After 6-9 days of lens wear
Other outcomes:
Locations:
city: Cupertino
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: San Jose
country: United States
state: California
city: Jacksonville
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
Study officials:
References: