Dispensing Evaluation of Printed Etafilcon A With Polyvinylpyrrolidone (PVP)
Status: | Completed |
---|---|
Conditions: | Ocular |
Therapuetic Areas: | Ophthalmology |
Healthy: | No |
Age Range: | 18 - 40 |
Updated: | 6/21/2018 |
Start Date: | July 1, 2010 |
End Date: | August 1, 2010 |
Dispensing Evaluation of Printed Etafilcon A With Polyvinylpyrrolidone (PVP) Contact Lenses
The purpose of this study is to evaluate the lens fit (mechanical and cosmetic lens fit) of
the printed etafilcon A with polyvinylpyrrolidone (PVP).
the printed etafilcon A with polyvinylpyrrolidone (PVP).
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.
We found this trial at
5
sites
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials