NCT00382902CompletedNot Applicable
Clinical Evaluation of the Safety and Efficacy of an Investigational Multi-Purpose Disinfecting Solution Compared to Two Marketed Multi-Purpose Solutions for Care of Silicone Hydrogel Soft Contact Lenses
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Alcon Research
- Enrollment
- 233
- Locations
- 2
- Primary Endpoint
- Lens Replacement Incidence and Causality
Study Overview
Brief Summary
The objective of the study was to clinically evaluate the safety and effectiveness of a new multi-purpose disinfecting solution in patients wearing silicone hydrogel soft contact lenses.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Successful daily wear of Night & Day® or Acuvue® Advance™ silicone hydrogel contact for at least two weeks.
- •Use of AOSEPT® ClearCare™ only as the pre-study care regimen for at least two weeks (rewetting drops use is also acceptable).
- •Successful lens wear for at least 8 hours per day.
- •Vision correctable to 20/
- •Normal eyes - no current ocular abnormalities that prevent successful contact lens wear.
- •No corneal surgery within the past 12 months.
- •No systemic disease that affects that eye or that could be worsened by the use of contact lenses or solutions.
- •No over-the-counter or prescription ocular medication.
- •No enrollment in another clinical study within 30 days prior to enrollment.
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Lens Replacement Incidence and Causality
Corrected Visual Acuity with Study Lenses (Snellen)
Average Lens Wearing Time
Average Uncomfortable Lens Wearing Time
Safety:
Slit-lamp Findings - Cornea: Edema, Neovascularization, Infiltrates; Injection, Tarsal Abnormalities and Other Complications
Corneal Fluorescein Staining (Type and Area)
Conjunctival Staining
Lens Deposits
Subject Questions/Subject Likert Questionnaire
Ocular Comfort and Symptom Scales
Adverse Events
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (2)
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