At a glance
ClinicalIndex Comparison Record- ✓Successful wearer of spherical soft contact lenses in both eyes for a minimum of 5 days per week and 8 hours per day during the past 3 months
- ✓Manifest cylinder ≤1.50 diopter in each eye
- ✓Best Corrected Visual Acuity 20/25 or better in each eye
- ✓Visual acuity with habitual spectacles 20/40 or better in both eyes, willing to wear spectacles during washout and study lens exposure
- ✕Any anterior segment infection, inflammation, abnormality, or disease that contraindicates contact lens wear
- ✕Any systemic or ocular medications for which contact lens wear could be contraindicated
- ✕History of refractive surgery or plan for refractive surgery during study, or irregular cornea in either eye
- ✕Ocular or intra-ocular surgery (excluding punctal plug placement) within 12 months prior to enrollment or planned during study
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Clinical Biocompatibility Evaluation of Contact Lens Coatings
In Brief
A clinical study evaluating Contact lens with investigational coating 1, Balafilcon A contact lens, and 2 other interventions for Refractive Errors and Ametropia. Completed, enrolled 33 participants across 1 site.
Detailed Summary
The primary objective is to evaluate corneal staining observed after 2 hours of wear with contact lenses with investigational coating against PureVision™ lenses, all pre-cycled with OPTI-FREE® RepleniSH® multi-purpose disinfection solution.
Study Details
Timeline
Interventions
Contact lens with investigational coating 1 pre-cycled in OPTI-FREE® RepleniSH® Multi-Purpose Disinfecting Solution (MPDS)
Balafilcon A contact lens pre-cycled OPTI-FREE® RepleniSH® MPDS
Multipurpose contact lens solution
Contact lens with investigational coating 2 pre-cycled in OPTI-FREE® RepleniSH® MPDS