A Clinical Comparison of Three Contact Lens Care Systems and Their Effect on Contact Lenses

Study Overview
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Brief Summary
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The purpose of this study was to evaluate the clinical performance of three differing contact lens care solutions when used in conjunction with three contact lenses.

Detailed Description
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This study was conducted as three separate studies based on the contact lens brand dispensed. In each study, the contact lens was evaluated in conjunction with three solutions: Opti-Free Replenish, ReNu MultiPlus, and Clear Care. The total enrollment number of 75 represents a combined enrollment of the three studies, with some subjects participating in more than one study.

Official Title
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A Clinical Comparison of Three Contact Lens Care Systems and Their Effect on Contact Lenses

Conditions
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Contact Lenses

Intervention / Treatment
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* Device: Opti-Free RepleniSH multi-purpose disinfecting solution
* Device: ReNu MultiPlus multi-purpose solution
* Device: Clear Care cleaning and disinfecting system
* Device: Senofilcon A contact lens (ACUVUE OASYS)
* Device: Lotrafilcon B contact lens (AIR OPTIX AQUA)
* Device: Comfilcon A contact lens (Biofinity)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed informed consent. Adapted contact lens wearer for at least one month. Spherical prescription range between +6.00 to -8.00 diopters. Astigmatism of less than or equal to 1.00 diopter in at least one eye. Normal eyes with no evidence of abnormality or disease. Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Rigid Gas Permeable (RGP) contact lens wear in last 30 days. Concurrent ocular medication, systemic illness, or medical treatment that will affect ocular physiology, lens performance, or vision. Corneal infiltrates, scarring, or neovascularization within central 4 millimeters of cornea. Eye injury or surgery within 8 weeks prior to study. Aphakia, amblyopia, abnormal lacrimal secretions, ocular irritation, keratoconus, corneal irregularity, pregnancy, lactating, planning to become pregnant during the study, and participation in a concurrent clinical trial. 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ACUVUE OASYS<br>Acuvue Oasys contact lenses worn on a daily wear basis and cleaned nightly with one of three contact lens care solutions. Each solution was used for 2 weeks, and the order in which the solutions were used was randomized. A fresh pair of lenses was dispensed with each solution. Total duration of contact lens wear was six weeks. | Device: Opti-Free RepleniSH multi-purpose disinfecting solution<br>* Contact lens solution CE-marked for intended use.<br>* Other names: Opti-Free® RepleniSH®;Device: ReNu MultiPlus multi-purpose solution<br>* Contact lens solution CE-marked for intended use.<br>* Other names: ReNu® MultiPlus®;Device: Clear Care cleaning and disinfecting system<br>* Contact lens care system CE-marked for intended use.<br>* Other names: Clear Care®;Device: Senofilcon A contact lens (ACUVUE OASYS)<br>* Silicone hydrogel contact lens worn for two weeks on a daily wear basis and cleaned nightly with one of three contact lens care solutions. The order of solutions was randomized, and a fresh pair of lenses was dispensed with each solution.<br>* Other names: ACUVUE® OASYS™;|
| Active Comparator: AIR OPTIX AQUA<br>Air Optix Aqua contact lenses worn on a daily wear basis and cleaned nightly with one of three contact lens care solutions. Each solution was used for 2 weeks, and the order in which the solutions were used was randomized. A fresh pair of lenses was dispensed with each solution. Total duration of contact lens wear was six weeks. | Device: Opti-Free RepleniSH multi-purpose disinfecting solution<br>* Contact lens solution CE-marked for intended use.<br>* Other names: Opti-Free® RepleniSH®;Device: ReNu MultiPlus multi-purpose solution<br>* Contact lens solution CE-marked for intended use.<br>* Other names: ReNu® MultiPlus®;Device: Clear Care cleaning and disinfecting system<br>* Contact lens care system CE-marked for intended use.<br>* Other names: Clear Care®;Device: Lotrafilcon B contact lens (AIR OPTIX AQUA)<br>* Silicone hydrogel contact lens worn for two weeks on a daily wear basis and cleaned nightly with one of three contact lens care solutions. The order of solutions was randomized, and a fresh pair of lenses was dispensed with each solution.<br>* Other names: AIR OPTIX® AQUA;|
| Active Comparator: Biofinity<br>Biofinity contact lenses worn on a daily wear basis and cleaned nightly with one of three contact lens care solutions. Each solution was used for 2 weeks, and the order in which the solutions were used was randomized. A fresh pair of lenses was dispensed with each solution. Total duration of contact lens wear was six weeks. | Device: Opti-Free RepleniSH multi-purpose disinfecting solution<br>* Contact lens solution CE-marked for intended use.<br>* Other names: Opti-Free® RepleniSH®;Device: ReNu MultiPlus multi-purpose solution<br>* Contact lens solution CE-marked for intended use.<br>* Other names: ReNu® MultiPlus®;Device: Clear Care cleaning and disinfecting system<br>* Contact lens care system CE-marked for intended use.<br>* Other names: Clear Care®;Device: Comfilcon A contact lens (Biofinity)<br>* Silicone hydrogel contact lens worn for two weeks on a daily wear basis and cleaned nightly with one of three contact lens care solutions. The order of solutions was randomized, and a fresh pair of lenses was dispensed with each solution.<br>* Other names: Biofinity®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modulus | Modulus is a measure of the stiffness of a contact lens material. Modulus is determined from the slope of the stress-strain curve created during tensile tests conducted on a sample of the material. Modulus is measured in mega Pascals (MPa). A higher modulus indicates a stiffer contact lens. | 2 weeks | 
| Bulbar hyperemia | Bulbar hyperemia is the injection (or redness) of the blood vessels in the tissues overlaying the white of the eye. Bulbar hyperemia is measured on a 0-4 scale, with 0=none, 1=trace, 2=mild, 3=moderate, and 4=severe. Half-grades are allowed. | 2 weeks | 
| Corneal staining type | An ophthalmic dye is used to highlight dead or degenerated corneal epithelial cells. The type of staining is measured over the five sectors of the cornea on a 0-4 scale, where 0=none, 1=micropunctate, 2=macropunctate, 3=coalesced macropunctate, and 4=patch (1mm). The five sectors are averaged to give a single score. | 2 weeks | 
| Upper palpebral roughness | The roughness of the inner lining of the upper eyelid is measured on a 0-4 scale, where 0=uniform appearance, 1=trace, 2=mild, 3=moderate, and 4=severe. Half grades are allowed. | 2 weeks | 
| High contrast visual acuity | High contrast visual acuity is a measure of the clearness of vision with full room illumination. Visual acuity is measured with a computer-generated, high contrast logMAR (logarithm minimum angle of resolution) chart. | 2 weeks | 
| End of day comfort | As assessed by the subject as a measure of the comfort of the contact lenses at the end of an average day. End of day comfort is recorded on an 11-point scale where 0=poor and 10=excellent. | 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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contact lenses, disinfection solutions, contact lens care