Evaluation of the Performance of Two Contact Lenses Compared to a Marketed Lens



Status:Completed
Conditions:Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:18 - 34
Updated:6/21/2018
Start Date:November 2011
End Date:February 2012

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Clinical Validation of Etafilcon A With Print and PVP Contact Lenses for Dark Eyes and Light Eyes

This study will serve to evaluate and compare the performance of two new lenses to a marketed
lens.


Inclusion Criteria:

- Healthy, female adult, at least 18 years of age, and no more than 34 years of age

- The subjects must be female, light eye Caucasian, Non-Hispanic, habitual soft contact
lens wearer (both eyes) with light or dark eyes

- Must have rated the Concept Statement positively (i.e., a rating of 4 or 5).

- Optimal vertexed spherical equivalent distance correction must be between -1.00 and
-4.00 diopters (D)

- Any cylinder power must be: <=0.75D

- Visual acuity must be best correctable to 20/25 or better for each eye

- Must have normal eyes (no ocular medications or ocular infection of any type)

- Must read and sign the Statement of Informed Consent

- 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, autoimmune disease, or use of medication which might interfere with
contact lens wear

- Clinically significant (grade 3 or worse) corneal edema, corneal neovascularization,
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 (colorblindness) - 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.

- Subject presents with one dark iris color and one light iris color.

- Subject has heterochromia iridis (a difference in color between parts of one iris).

- The subject must not be an employee or family member of the clinical study site.
We found this trial at
15
sites
Laramie, Wyoming 82070
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Laramie, WY
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2103 East Washington Street
Bloomington, Illinois 61701
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Bloomington, IL
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East Lansing, Michigan 48826
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East Lansing, MI
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Grants Pass, Oregon 97526
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Grants Pass, OR
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Jamestown, New York 14702
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Jamestown, NY
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Katy, Texas 77450
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Katy, TX
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Middleton, Wisconsin 53562
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Middleton, WI
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Mission Viejo, California 92691
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Mission Viejo, CA
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Mission Viejo, California 92691
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Mission Viejo, CA
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Pismo Beach, California 93448
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Pismo Beach, CA
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Pittsburg, Kansas 66762
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Pittsburg, KS
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Sarasota, Florida 34242
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Sarasota, FL
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Vestal, New York 13850
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Vestal, NY
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Warwick, Rhode Island 02887
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Warwick, RI
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Winter Park, Florida 32792
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Winter Park, FL
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