N/A
Completed N=66
Evaluation of a New Silicone Hydrogel Contact Lens
Source: ClinicalTrials.gov NCT01309880 ↗Enrolled (actual)
66
Serious AEs
0.0%
Results posted
Feb 2015
Primary outcomePrimary: Visual Acuity — -0.083; -0.085; -0.084; -0.078 logMAR
Summary
The objective of this study is to determine the clinical feasibility and to evaluate the product performance of investigational contact lenses developed by Bausch + Lomb.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Visual Acuity |
-0.083; -0.085; -0.084; -0.078 | — |
| SECONDARY Slit Lamp Findings |
46; 82; 86; 50; 0; 0 | — |
| SECONDARY Comfort |
85.5; 81.8 | — |
Eligibility Criteria
Inclusion Criteria
- Have physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings.
- Be adapted wearers of soft contact lenses, wear a lens in each eye, and each lens must be of the same manufacture and brand.
Exclusion Criteria
- Have worn gas permeable (GP) contact lenses within last 30 days or polymethylmethacrylate (PMMA) lenses within last 3 months.
- Any systemic disease affecting ocular health.
- Using any systemic or topical medications that will affect ocular physiology or lens performance.
- An active ocular disease, any corneal infiltrative response or are using any ocular medications.
- Any "Present" finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear.
- Allergic to any component in the study care products.
Data sourced from ClinicalTrials.gov (NCT01309880). 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.