Non-dispensing Study to Check Prescription Equivalence of Two Daily Disposable Toric Contact Lens Types
Status: | Completed |
---|---|
Conditions: | Ocular |
Therapuetic Areas: | Ophthalmology |
Healthy: | No |
Age Range: | 18 - 40 |
Updated: | 6/21/2018 |
Start Date: | February 1, 2010 |
End Date: | February 1, 2010 |
The purpose of this study is to determine whether the prescription determined for a new daily
disposable toric contact lens will be a good match to a prescription determined for an
existing brand of lens.
disposable toric contact lens will be a good match to a prescription determined for an
existing brand of lens.
Inclusion Criteria:
1. The subject must be between 18 and 40 years old.
2. The subject must have normal eyes.
3. The subject must appear able and willing to adhere to the instructions set forth in
this clinical protocol.
4. The subject must read and sign the STATEMENT OF INFORMED CONSENT and be provided a
copy of the form.
5. The subject must have a subjective distance spectacle prescription in the range of
-1.75 to -5.00 DS in each eye.
6. The subject must manifest -1.25 to -2.00 D of refractive astigmatism in each eye.
7. The subject's refractive cylinder axis must be 180 +/- 30 in each eye.
8. The subject must be an adapted wearer of soft toric contact lenses in both eyes.
9. The subject's best visual acuity (BVA) must be better than or equal to 20/25 in each
eye.
10. Subjects must already possess a wearable pair of spectacles. -
Exclusion Criteria:
1. Ocular or systemic allergies or disease that may interfere with contact lens wear.
2. Systemic disease or autoimmune disease or use of medication, which may interfere with
contact lens wear.
3. Clinically significant corneal edema, corneal vascularization, corneal staining or any
other abnormality of the cornea, which may contraindicate contact lens wear.
4. Clinically significant tarsal abnormalities that might interfere with contact lens
wear.
5. Any ocular infection.
6. Any corneal distortion resulting from previous hard or rigid gas permeable contact
lens wear.
7. Pregnancy or lactation
8. Any infectious disease (e.g., hepatitis, tuberculosis) or an immunosuppressive disease
(e.g., HIV).
9. Diabetes
10. Strabismus -
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