Evaluation of a Multi-Purpose Solution

Study Overview
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Brief Summary
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This study evaluates a multi-purpose solution when used on a daily wear basis by currently adapted soft contact lens wearers.

Official Title
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A Study to Evaluate the Clinical Performance of a Multi-Purpose Solution.

Conditions
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Contact Lens Solutions

Intervention / Treatment
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* Device: Bausch & Lomb Multi-Purpose Solution


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Is an adapted Group I or Group IV soft contact lens wearer and agrees to wear the study lenses on a daily wear basis. Must be able and willing to comply with all treatment and follow-up study procedures. Must have a clear central cornea. VA correctable to 0.3 LogMar or better (driving vision) Exclusion Criteria: Systemic disease affecting ocular health. Using systemic or topical medications. Wear monovision, multifocal or toric contact lenses. Any grade 2 or greater slit lamp findings. Pregnancy

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: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Multipurpose Solution<br>Multi-purpose solution administered to adapted FDA group I soft contact lens wearers and FDA group IV soft contact lens wearers. | Device: Bausch & Lomb Multi-Purpose Solution<br>* Daily care for contact lenses.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antimicrobial Efficacy | Excellent = No bacterial infection suspected and no ocular pathogens detected and bacteria of normal flora <0-103 CFU/mL. Good = No bacterial infection suspected and no ocular pathogens detected and bacteria of normal flora <103-105 CFU/mL. Skeptical = Bacterial infection suspected and ocular pathogens detected and bacteria of normal flora ≥ 105 CFU/mL. No Efficacy = Bacterial infection definite and ocular pathogens detected and bacteria of normal flora ≥ 105 CFU/mL. Pathogens were H. aegyptius, H. influenzae, Moraxella spp., P. aeruginosa, S. pneumoniae, S. aureus, N. gonorrhoeae | 2 weeks, 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Solution Related AE's and Lens Changes | Very Safe = No solution related AEs and no changes in lens properties related to the solution. Safe = No solution related AEs and slight change in lens properties related to the solution, but lens wear was continued. Skeptical = Solution related AEs were suspected and lens properties changed due to the solution and lens wear was discontinued. Not Safe = Solution related AEs were present and lens properties changed due to the solution and lens wear was discontinued. | 3 months, 6 months | 
| Solution Utlility | The Utility was determined based on the results of the efficacy and safety evaluations. | 3 months, 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Efficacy