NCT00382603CompletedNot Applicable
Clinical Evaluation of the Safety and Efficacy of an Investigational Multi-Purpose Disinfecting Solution Compared to a Marketed Multi-Purpose Solution for Care of Soft Contact Lenses in Symptomatic Patients
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Alcon Research
- Enrollment
- 362
- Locations
- 2
- Primary Endpoint
- Efficacy:
Study Overview
Brief Summary
The objective of the study was to clinically evaluate the safety and effectiveness of a new multi-purpose disinfecting solution for soft contact lenses in patients who experience discomfort with their contact lenses.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Symptomatic for contact lens related discomfort at the end of the lens wearing day.
- •Successful daily wear of FDA Group IV lenses on a two-week or longer replacement schedule for at least two weeks.
- •Use of a multi-purpose solution only as the pre-study care regimen for at least one month (rewetting drops use is also acceptable).
- •Successful lens wear for at least 4 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
Efficacy:
Ocular Comfort and Symptom Scales
Subject Questions/Subject Likert Questionnaire
Safety:
Slit-lamp Findings - Cornea: Edema, Neovascularization, Infiltrates; Injection, Tarsal Abnormalities and Other Complications
Adverse Events
Secondary Outcomes
- Corneal Fluorescein Staining (Type and Area)
- Lens Surface Evaluation (Lens Deposit and Lens Wettability)
- Lens Replacement Incidence and Causality
- Corrected Visual Acuity with Study Lenses (Snellen)
- Rewetting Drop Frequency
- Lens Removal Frequency
- Average Lens Wearing Time
- Average Uncomfortable Lens Wearing Time
Investigators
Study Sites (2)
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