Clinical Performance of a Silicone Hydrogel Lens With Use of FID 114675A

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the clinical performance of a silicone hydrogel contact lens when used with an investigational multi-purpose disinfecting solution (MPDS).

Official Title
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Clinical Performance of a Marketed Silicone Hydrogel Contact Lens When Used With Silicone Hydrogel MPDS FID 114675A

Conditions
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Contact Lens Fit, Myopia

Intervention / Treatment
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* Device: FID 114675A multi-purpose disinfecting solution (MPDS)
* Device: renu fresh Multi-Purpose Solution (MPS)
* Device: Galyfilcon A contact lenses (Acuvue Advance)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years of age or older. History of at least 5 days successful daily wear (minimum 8 hours per day) of spherical, single power Acuvue® Advance® SiH contact lenses prior to Visit 1. Wear contact lenses a minimum of 8 hours per day prior to Visit 1. Vision correctable to 20/30 (Snellen) or better in each eye at distance with study lenses at Visit 1. Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Need to wear contact lenses on an extended wear basis (i.e., overnight) during the study. Use of products other than a multi-purpose solution to care for lenses at least 7 days prior to Visit 1. Pre-study use of rewetting drops is acceptable. History of intolerance or known sensitivity to any component of the treatments. Use of over-the-counter (OTC) or prescribed topical ocular medications within 7 days prior to Visit 1. 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: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: FID 114576A / renu fresh<br>FID 114675A used for contact lens care per protocol-specified instructions for 14 days, followed by a minimum 1-day washout period, after which renu fresh used for contact lens care for an additional 14 days. | Device: FID 114675A multi-purpose disinfecting solution (MPDS)<br>* Daily regimen, 14 days: Thoroughly wet and rub each side of study contact lens for 10 seconds, rinse each side of the lens for 10 seconds, and soak contact lens for at least 6 hours.<br>* Other names: Alcon Multi-Purpose Disinfecting Solution (MPDS);Device: renu fresh Multi-Purpose Solution (MPS)<br>* Daily regimen, 14 days: Wet study contact lens with 3 drops and rub each side of the lens for 20 seconds, rinse each side of the lens for 5 seconds, and soak contact lens for at least 4 hours.<br>* Other names: Bausch + Lomb renu® fresh™ Multi-Purpose Solution;Device: Galyfilcon A contact lenses (Acuvue Advance)<br>* A fresh pair of contact lenses matching subject's pre-study lenses, including parameters, dispensed at the beginning of each period for daily wear, minimum 8 hours per day, 14 days.<br>* Other names: Acuvue® Advance®;|
| Other: renu fresh / FID 114675A<br>Renu fresh used for contact lens care per protocol-specified instructions for 14 days, followed by a minimum 1-day washout period, after FID 114675A used for contact lens care for an additional 14 days. | Device: FID 114675A multi-purpose disinfecting solution (MPDS)<br>* Daily regimen, 14 days: Thoroughly wet and rub each side of study contact lens for 10 seconds, rinse each side of the lens for 10 seconds, and soak contact lens for at least 6 hours.<br>* Other names: Alcon Multi-Purpose Disinfecting Solution (MPDS);Device: renu fresh Multi-Purpose Solution (MPS)<br>* Daily regimen, 14 days: Wet study contact lens with 3 drops and rub each side of the lens for 20 seconds, rinse each side of the lens for 5 seconds, and soak contact lens for at least 4 hours.<br>* Other names: Bausch + Lomb renu® fresh™ Multi-Purpose Solution;Device: Galyfilcon A contact lenses (Acuvue Advance)<br>* A fresh pair of contact lenses matching subject's pre-study lenses, including parameters, dispensed at the beginning of each period for daily wear, minimum 8 hours per day, 14 days.<br>* Other names: Acuvue® Advance®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lens Fit | As assessed by the investigator using a composite score based on three lens fit measures: static, push-up, and centration. Static and pushup were assessed on a 5-point scale, where -2=reduced movement unacceptable, -1=reduced movement acceptable, 0=optimal movement, 1=excessive movement acceptable, 2=excessive movement unacceptable. Centration was assessed on a 3-point scale, where 0=optimal lens centration, 1=acceptable decentration, 2=unacceptable decentration. A subject with an assessment of optimal or acceptable for each measure was considered acceptable on all measurements. | Day 14 of lens wear | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change From Baseline for Circumlimbal Conjunctival Staining Sum Score | The bulbar conjunctiva was assessed by the investigator at baseline and Day 14 utilizing a slit-lamp and ophthalmic dye. Staining coverage was scored separately in each of four regions (nasal, temporal, inferior, and superior) using a 5-point photographic reference scale, where 0=0.00% coverage and 4=10% or greater coverage. The scores for the four regions were summed, with a sum score range of 0-16. | Day 14 of lens wear | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Contact Lens Wear, Contact Lens Solution, Multi-purpose disinfecting solution, Myopia