Evaluation of an Investigational Multi-Purpose Disinfecting Solution for the Care of Soft Contact Lenses in Symptomatic Patients

Study Overview
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Brief Summary
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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.

Official Title
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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
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Contact Lens Care

Intervention / Treatment
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* Device: OptiFree Multi-Purpose Disinfecting Solution


Participation Criteria
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Eligibility Criteria
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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 20/30. 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: OptiFree Multi-Purpose Disinfecting Solution|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Contact Lens Care