Effect of an Investigational Multi-Purpose Solution on Lens Moisture

Study Overview
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Brief Summary
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The purpose of the study is to evaluate the effect of an investigational multi-purpose disinfecting solution (MPDS) compared to a marketed multi-purpose solution on the moisture of silicone hydrogel contact lenses.

Official Title
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Effect of SiH MPDS FID 114675A vs. a Marketed Multi-Purpose Solution on Lens Moisture

Conditions
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Contact Lens Moisture

Intervention / Treatment
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* Device: FID 114675A Multi-Purpose Disinfecting Solution (MPDS)
* Device: ReNu Fresh Lens Comfort Multi-Purpose Solution (MPS)
* Device: Silicone Hydrogel Contact Lenses


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years of age or older. Wears silicone hydrogel contact lenses on a daily wear basis i.e. disinfects lenses every night). Has successfully worn contact lenses for 5 days, 8 hours per day, prior to baseline visit. Vision is correctable to 20/30 or better in each eye at distance with study lenses at baseline visit. Other protocol-specified inclusion criteria may apply. Exclusion Criteria: Known sensitivity or intolerance to contact lens multi-purpose solutions. Use of any topical ocular OTC or prescribed topical ocular medications. History or current ocular infections or ocular inflammatory events. Ocular surgery within the past year. Medical condition or use of medication that cause ocular side effects. Participation in any investigational study within the past 30 days. Other protocol-defined exclusion criteria may apply.

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FID 114675A<br>Multi-purpose disinfecting solution used per protocol-specified instructions for cleaning, rinsing, disinfecting/storing, and reinserting study contact lenses | Device: FID 114675A Multi-Purpose Disinfecting Solution (MPDS)<br>* Investigational solution intended for use as a cleaning, rinsing, reconditioning, disinfecting, and storage solution for silicone hydrogel and soft contact lenses<br>Device: Silicone Hydrogel Contact Lenses<br>* Commercially marketed silicone hydrogel contact lenses per habitual prescription for daily wear use, at least 8 hours/day. New pair dispensed at Day 0 (Baseline Visit) and at the conclusion of Day 1 (Visit 2).<br>* Other names: PureVision®;|
| Active Comparator: ReNu MultiPlus<br>Multi-purpose solution used per protocol-specified instructions for cleaning, rinsing, disinfecting/storing, and reinserting study contact lenses | Device: ReNu Fresh Lens Comfort Multi-Purpose Solution (MPS)<br>* Commercially marketed prodouct indicated for cleaning, removing protein deposits, rinsing, disinfecting, and storing soft contact lenses<br>* Other names: ReNu MultiPlus® Multi-Purpose Solution Fresh Lens Comfort™;Device: Silicone Hydrogel Contact Lenses<br>* Commercially marketed silicone hydrogel contact lenses per habitual prescription for daily wear use, at least 8 hours/day. New pair dispensed at Day 0 (Baseline Visit) and at the conclusion of Day 1 (Visit 2).<br>* Other names: PureVision®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Ex-Vivo Advancing Contact Angle | Study lens was removed from the eye according to protocol-specified procedures. The OCA15 (Optical Contact Angle) Instrument was used to observe, record, and calculate contact angle measurements. The wetting angle measurement was recorded in degrees (0-180), and a lower wetting angle measurement indicates a more wettable lens. | Day 1, 8 hours | 
| Mean Ex-Vivo Advancing Contact Angle | Study lens was removed from the eye according to protocol-specified procedures. The OCA15 (Optical Contact Angle) Instrument was used to observe, record, and calculate contact angle measurements. The wetting angle measurement was recorded in degrees (0-180), and a lower wetting angle measurement indicates a more wettable lens. | Day 8, 16 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Contact Lenses, Contact Lens Care, Multi-Purpose Solution