Safety and Efficacy of a Bausch & Lomb Multipurpose Solution When Compared to Ciba Vision Aquify Multipurpose Solution

Study Overview
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Brief Summary
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To the safety and efficacy of a Bausch & Lomb Multipurpose Solution when compared to Ciba vision Aquify Multipurpose solution

Conditions
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Contact Lens Solutions

Intervention / Treatment
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* Device: Bausch & Lomb Multipurpose Solution - Rub Care
* Device: Bausch & Lomb Multipurpose Solution - No Rub Care
* Device: Ciba Vision Aquify Multipurpose Solution


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: subject is a habitual wearer of a silicone hydrogel or group IV contact lens VA correctable to 0.3 LogMar or better (driving vision) Clear central cornea Subject uses a lens care system on a regular basis 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

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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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Multipurpose Solution - Rub Care<br>Bausch & Lomb Multipurpose Solution for use with contact lens care | Device: Bausch & Lomb Multipurpose Solution - Rub Care<br>* Daily care for contact lenses - rub care regimen<br>|
| Experimental: Multipurpose Solution - No Rub Care<br>Bausch & Lomb Multipurpose Solution for use with contact lens care | Device: Bausch & Lomb Multipurpose Solution - No Rub Care<br>* Daily care for contact lenses - no rub care regimen<br>|
| Active Comparator: Ciba Vision Aquify Multipurpose Solution<br>Ciba Vision Aquify Multipurpose Solution for use with contact lens care | Device: Ciba Vision Aquify Multipurpose 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 |
| --- | --- | --- |
| Slit-lamp Findings > Grade 2 | eyes with any slit lamp findings greater than Grade 2 at any visit. Slit lamp findings for each eye will be graded for severity on a scale from 0 (No Finding) to 4 (Severe Finding). Epithelial edema, epithelial microcysts, corneal staining, limbal injection, bulbar injection, superior tarsal conjunctival abnormalities, corneal neovascularization, and corneal infiltrates will be assessed. | Over 4 visits for 3 month period | 
| Subjective Responses to Comfort Related Symptoms/Complaints | Subject symptoms/complaints will be assessed on a scale from 0 to 100, with 0 denoting unfavorable symptoms/complaints. | Over 4 visits for the 3 month period | 
| Contact Lens Deposits | Lens deposits assessed at each follow-up visit. Degree of deposits assessed as none, light, medium, or heavy. | At each visit for 3 months |