Dispensing Evaluation of New Daily Disposable Toric Soft Contact Lens.
Status: | Completed |
---|---|
Conditions: | Ocular |
Therapuetic Areas: | Ophthalmology |
Healthy: | No |
Age Range: | 18 - 40 |
Updated: | 6/21/2018 |
Start Date: | January 2010 |
End Date: | February 2010 |
The purpose of this study is to determine the relative performance of a new daily disposable
toric soft contact lens against a daily disposable toric contact lens currently available in
market, specifically with regards to the comfort and vision with the lens.
toric soft contact lens against a daily disposable toric contact lens currently available in
market, specifically with regards to the comfort and vision with the lens.
Inclusion Criteria:
- The subject must be between 18 and 40 years old.
- The subject must have normal eyes.
- The subject must appear able and willing to adhere to the instructions set forth in
this clinical protocol.
- The subject must read and sign the STATEMENT OF INFORMED CONSENT and be provided a
copy of the form.
- The subject must have a subjective distance spectacle prescription in the range of
-1.75 to -5.00D in each eye.
- The subject must manifest -1.25 to -2.00 D of refractive astigmatism in each eye.
- The subject's refractive cylinder axis must be 180 degrees plus or minus 30 degrees in
each eye.
- The subject must be an adapted wearer of soft toric contact lenses in both eyes.
- The subject's best visual acuity (BVA) must be better than or equal to 20/25 in each
eye.
- Subjects must already possess a wearable pair of spectacles.
Exclusion Criteria:
- Ocular or systemic allergies or disease that may interfere with contact lens wear.
- Systemic disease or autoimmune disease or use of medication, which may interfere with
contact lens wear.
- Clinically significant (grade 3 or 4) corneal edema, corneal vascularization, corneal
staining or any other abnormality of the cornea, which may contraindicate contact lens
wear.
- Clinically significant (grade 3 or 4) tarsal abnormalities that might interfere with
contact lens wear.
- Any ocular infection.
- Any corneal distortion resulting from previous hard or rigid gas permeable contact
lens wear.
- Pregnancy or lactation
- Any infectious disease (e.g., hepatitis, tuberculosis) or an immunosuppressive disease
(e.g., HIV).
- Diabetes
- Strabismus
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