Vistakon Investigational Multi-purpose Contact Lens Care Solution.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Contact Lens Wear
- Sponsor
- Johnson & Johnson Vision Care, Inc.
- Enrollment
- 315
- Primary Endpoint
- Slit Lamp Findings (SLF)
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
This study compares an investigational contact lens care multi-purpose solution to a currently marketed multi-purpose solution.
Investigators
Eligibility Criteria
Inclusion Criteria
- •must be an adapted contact lens wearer
- •best corrected distance visual acuity must be 20/25 or better in each eye
- •must be wearing their habitual lenses on a daily wear basis
- •must be willing to refrain from swimming during the study
Exclusion Criteria
- •any systemic diseases that may interfere with contact lens wear
- •any clinically significant ocular disease
- •any ocular infection
- •use of certain medications
- •any grade 2 or greater slit lamp findings
- •any know sensitivity to marketed contact lens care solutions
- •currently pregnant or lactating
- •monovision corrected
Outcomes
Primary Outcomes
Slit Lamp Findings (SLF)
Time Frame: Up to 3 months Post Lens Wear
Slit Lamp Findings were assessed for each subject eye at baseline, 1-day, 1-week, 2-week, 1-month and 3-month follow-up evaluations. SLF consisted of Edema, Corneal Neovascularization, Cornela Staining, Injection, Tarsal Abnormalities and Other findings; each was graded on a 5-likert Scale (Grade: None, Grade 1: Trace, Grade 2: Mild, Grade 3: Moderate and Grade 4: Severe). The number of eyes with Grade 2 or higher across all time points for each SLF variable was reported.
Distance Visual Acuity (LogMAR)
Time Frame: Up to 3 Months Post Lens Wear
Distance Visual Acuity (LogMAR) was assessed for each subject eye at 1-week, 2-week, 1-month and 3-month follow-up evaluations. The average Visual Acuity (LogMAR) for each time point and lens was reported.