N/A
Completed N=113
Comparison of Two Soft Bifocal Contact Lenses
Source: ClinicalTrials.gov NCT00724945 ↗Enrolled (actual)
113
Serious AEs
0.0%
Results posted
Jan 2010
Primary outcomePrimary: Distance Visual Acuity — -0.08591; -0.10267 logMAR units
Summary
The purpose of the study is to compare the visual performance of two soft bifocal contact lenses.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Distance Visual Acuity |
-0.08591; -0.10267 | — |
| PRIMARY Near Visual Acuity |
0.02711; 0.01933 | — |
| PRIMARY Subject Vision |
3.4594; 3.3853 | — |
Eligibility Criteria
Inclusion Criteria
- The subject must between 35 and 70 years of age.
- The subject must have presbyopic symptoms or be already wearing presbyopic contact lens correction.
- The subject's spherical equivalent distance refraction must be in the range of -1.00 to -6.00 or -9.00 to -10.00 in each eye.
- Refractive cylinder must be -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 OU 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 an immunosuppressive disease (e.g., HIV).
- History of diabetes
- History of binocular vision abnormality or strabismus
Data sourced from ClinicalTrials.gov (NCT00724945). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.