Comparison of Three Soft Bifocal Contact Lenses
Status: | Completed |
---|---|
Conditions: | Ocular |
Therapuetic Areas: | Ophthalmology |
Healthy: | No |
Age Range: | 35 - 70 |
Updated: | 6/21/2018 |
Start Date: | November 1, 2008 |
End Date: | December 1, 2008 |
The primary purpose of the study is to compare the performance of three soft bifocal contact
lenses in terms of the vision provided by the lenses.
lenses in terms of the vision provided by the lenses.
Inclusion Criteria:
- The subject must between 35 and 70 years of age.
- The subject must respond positively to at least one symptom on the "Presbyopic
Symptoms Questionnaire" or be already wearing presbyopic contact lens correction (
e.g. reading spectacles over contact lenses, multifocal or monovision contact lenses
etc.).
- The subject's spherical equivalent distance refraction must be in the range of -1.00
to -6.00 in each eye.
- Refractive cylinder must be less than or equal to -0.75 D in each eye.
- The subject must have an add power of +0.75D to +2.50D in each eye.
- The subject must have best corrected visual acuity of 20/20-3 or better in each eye.
- The subject's must have at least 20/30-distance vision with the study contact lenses.
- The subject must agree that they are comfortable with their vision prior to being
dispensed the study lenses.
- The subject must be an adapted soft contact lens wearer in both 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.
Exclusion Criteria:
- Ocular or systemic allergies or disease that may interfere with contact lens wear.
- Systemic disease, 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 a contagious
immunosuppressive disease (e.g., HIV).
- History of diabetes. History of binocular vision abnormality or strabismus.
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