Dispensing Evaluation of a Prototype Contact Lens and a Marketed Contact Lens



Status:Completed
Conditions:Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:18 - 39
Updated:6/21/2018
Start Date:February 1, 2010
End Date:March 1, 2010

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The purpose of this study is to compare visual acuity and redness of eyes between a prototype
contact lens and an already marketed contact lens.


Inclusion Criteria:

1. The subject must be at least 18 years of age and no more than 39 years of age.

2. The subject is a current spherical soft contact lens wearer (defined as a minimum of 6
hours of DW for a minimum of 1 month prior to the study) and willing to wear the study
lenses on a daily wear basis (defined as a minimum of 6 hours of wear per day at least
five days of the week) for the duration of the study.

3. The subject's optimal vertexed spherical equivalent distance correction must be
between -1.00 and - 9.00D.

4. Any cylinder power must be ≤ -0.75D.

5. The subject must have visual acuity best correctable to 20/25+3 or better for each
eye.

6. The subject must read and sign the Statement of Informed Consent.

7. 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 4) 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. Pregnancy or lactation.

8. Diabetes.

9. Infectious diseases (e.g. hepatitis, tuberculosis) or an immuno-suppressive disease
(e.g. HIV).

10. Habitual contact lens type is toric, multifocal, or is worn as extended wear.
We found this trial at
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