Dispensing Evaluation of Subjective Comfort, Vision, and Handling of a New Lens 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 |
Dispensing Evaluation of Lens Comfort and Subjective Vision of an Etafilcon A With Print and PVP Lens for Dark Eyes
To evaluate and compare the performance of a new contact lens to a marketed contact lens.
Inclusion Criteria:
- The subject must be a healthy adult at least 18 years of age and no more than 34 years
of age.
- The subjects must be female, dark eye Caucasian, Non-Hispanic habitual soft contact
lens wearer (both eyes).
- The subject rated the Concept Statement positively (i.e., a rating of 4 or 5). If not
the subject is not eligible to participate.
- 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 -4.00D.
- Any cylinder power must be:<=0.75D.
- The subject must have visual acuity best correctable to 20/25 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, 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 (color blindness) - 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 is an employee or family member of the clinical study site.
We found this trial at
6
sites
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