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

Use our guide to learn which trials are right for you!

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
?
mi
from
Jamestown, NY
Click here to add this to my saved trials
?
mi
from
Bloomfield, CT
Click here to add this to my saved trials
?
mi
from
Kingston, PA
Click here to add this to my saved trials
?
mi
from
Moon, PA
Click here to add this to my saved trials
?
mi
from
Overland Park, KS
Click here to add this to my saved trials
?
mi
from
Tallahassee, FL
Click here to add this to my saved trials