A Study to Evaluate the Clinical Performance of a Novel Multipurpose Solution

Study Overview
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Brief Summary
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The objective of this study is to evaluate the clinical performance of Bausch & Lomb investigational Multi-Purpose Solution compared to Ciba Vision Multi-Purpose Solution when used by wearers of silicone hydrogel or Group IV contact lenses.

Official Title
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A Study to Evaluate the Clinical Performance of a Novel Multipurpose Solution

Conditions
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Ocular Discomfort

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants must be of legal age (at least 18) on the date the Informed Consent Form (ICF) is signed and with the capacity to provide voluntary informed consent. Participants must habitually use a lens care product for lens cleaning, disinfecting, and storage. Participants must wear a lens in each eye and each lens must be of the same manufacture and brand. Participants must agree to wear study lenses on a daily wear basis. Participants must be able and willing to comply with all treatment and follow-up/study procedures. Exclusion Criteria: Participants participating in any drug or device clinical investigation within 2 weeks prior to entry into this study and/or during the period of study participation. Participants with any systemic disease affecting ocular health. Participants using any systemic or topical medications that will, in the Investigator's opinion, affect ocular physiology or lens performance. Participants who have had any corneal surgery (eg, refractive surgery). Participants who are allergic to any component in the study care products.

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: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bausch & Lomb Multi-Purpose Solution<br>Multi-Purpose Solution to be used for disinfecting contact lenses. | Device: Bausch & Lomb Multi-Purpose Solution<br>* Lens care product for disinfecting lenses on a daily basis.<br>|
| Active Comparator: Ciba's Multi-Purpose Solution<br>Multi-Purpose Solution to be used for disinfecting contact lenses. | Device: Ciba's Multi-Purpose Solution<br>* Lens care product for disinfecting lenses on a daily basis.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comfort-related Symptoms/Complaints | Participants rated their subjective symptoms/complaints using a 0 to 100 scale for each eye. A 0 represented the least favorable rating, and a 100 represented the most favorable rating. Over All Follow-Up Visits summarizes the average over all follow-up visit summaries. | At dispensing visit and each follow-up visit at week 2 and week 4. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Slit Lamp Findings | Graded slit lamp findings for each eye greater than grade 2 included epithelial edema, epithelial microcysts, corneal staining, limbal injection, bulbar injection, superior tarsal conjunctival abnormalities, corneal neovascularization, and corneal infiltrates. Slit lamp findings are grade on a scale of 0-4 with 0=none and 4=severe. Over All Follow-up Visits summarizes the worst case over all follow-up visits. | Over all visits for 1 month |