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 |
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.
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
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