N/A
Completed N=100
A Study to Evaluate the Product Feasibility of a New Silicone Hydrogel Contact Lens
Source: ClinicalTrials.gov NCT01412983 ↗Enrolled (actual)
100
Serious AEs
0.0%
Results posted
Apr 2014
Primary outcomePrimary: Visual Acuity — -0.054; -0.051 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 |
-0.054; -0.051 | — |
| SECONDARY Overall Comfort |
81.9; 82.7 | — |
Eligibility Criteria
Inclusion Criteria
- Have physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings (greater than grade 1 and/or presence of infiltrates).
- Be adapted wearers of soft contact lenses, wear a lens in each eye, and each lens must be of the same manufacture and brand.
- Be correctable through spherocylindrical refraction to 32 letters (0.3 logMAR) or better (distance, high contrast) in each eye.
- Be myopic and require lens correction from -0.50 to -6.00 diopters (D) in each eye.
Exclusion Criteria
- An active ocular disease, any corneal infiltrative response or are using any ocular medications.
- Have worn gas permeable (GP) contact lenses within last 30 days or PMMA lenses within last 3 months.
- Any Grade 2 or greater finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear.
- Any scar or neovascularization within the central 4mm of the cornea.
- Have had any corneal surgery.
- Any "Present" finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear.
- Any systemic disease affecting ocular health.
- Using any systemic or topical medications that will affect ocular physiology or lens performance.
- Currently wear monovision, multifocal, or toric contact lenses.
- Allergic to any component in the study care products.
Data sourced from ClinicalTrials.gov (NCT01412983). 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.