N/A
N=92
Dispensing Evaluation of Printed Etafilcon A With Polyvinylpyrrolidone (PVP)
Myopia
Bottom Line
View on ClinicalTrials.gov: NCT01180777 ↗Enrolled (actual)
92
Serious AEs
1.1%
Results posted
Mar 2014
Primary outcome: Primary: Lens Fit Acceptance — 158; 158; 157; 0 eyes
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- etafilcon A (A) (Device); etafilcon A (B) (Device); etafilcon A (C) (Device)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Johnson & Johnson Vision Care, Inc.
- Primary completion
- Aug 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Lens Fit Acceptance |
158; 158; 157; 0; 2; 0 | — |
| SECONDARY Binocular Snellen Visual Acuity (VA) |
42; 39; 45; 36; 39; 33 | — |
| SECONDARY Corneal Staining |
4; 6; 3; 34; 25; 44 | — |
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
- 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 Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT01180777). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.