Multipurpose Disinfecting Solution Compatibility With a Silicone Hydrogel Contact Lens

Study Overview
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Brief Summary
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The purpose of this study is to verify the compatibility of a silicone hydrogel lens when used with four multipurpose disinfecting solutions (OPTI-FREE® RepleniSH®, ReNu MultiPlus®, Solo-Care Aqua™ and MeniCareTM Soft).

Detailed Description
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The purpose of this study is to verify the compatibility of a silicone hydrogel lens when used with four multipurpose disinfecting solutions (OPTI-FREE® RepleniSH®, ReNu MultiPlus®, Solo-Care Aqua™ and MeniCareTM Soft) by observing changes within the cornea.

Official Title
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Multipurpose Solution Compatibility With a Silicone Hydrogel Lens

Conditions
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Myopia, Hyperopia

Intervention / Treatment
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* Device: Silicone Hydrogel Contact Lens


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A person is eligible for inclusion in the study if he/she: Is at least 17 years old and has full legal capacity to volunteer Has read and signed an information consent letter, after having the opportunity to ask questions and receive acceptable answers Is willing and able to follow instructions and maintain the study appointment schedule Is correctable to a visual acuity of 6/7.5 (20/25) or better (both eyes) with their habitual vision correction Has normal binocular vision (no strabismus, no amblyopia, and anisometropia less than or equal to 1.00 D) Has clear corneas and no active ocular disease Has had an ocular examination in the last two years. Has a functional pair of spectacles Is a current soft lens wearer replacing their lenses at least monthly Has a distance contact lens prescription between +6.00D to -10.00 DS and can be successfully fitted with the study lens Has astigmatism less than or equal to -1.00DC Agrees to wear the study lenses on a daily wear basis Exclusion Criteria: A person will be excluded from the study if he/she: Has any signs or symptoms of dry eye Has any clinically significant blepharitis Has undergone corneal refractive surgery Is aphakic Has any systemic disease affecting ocular health Is using any systemic or topical medications that may affect ocular health Is pregnant or lactating Is participating in any other type of clinical or research study Currently wears daily disposable lenses Currently wears lenses on a continuous or extended wear basis Is unable to successfully wear contact lenses without routinely using rewetting drops

Ages Eligible for Study
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Minimum Age: 17 Years
Maximum Age: 55 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: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br> | Device: Silicone Hydrogel Contact Lens<br>* use of lens over 2 days<br>* Other names: Premio;|
| Active Comparator: 2<br> | Device: Silicone Hydrogel Contact Lens<br>* use of lens over 2 days<br>* Other names: Premio;|
| Active Comparator: 3<br> | Device: Silicone Hydrogel Contact Lens<br>* use of lens over 2 days<br>* Other names: Premio;|
| Active Comparator: 4<br> | Device: Silicone Hydrogel Contact Lens<br>* use of lens over 2 days<br>* Other names: Premio;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To see if there are any effects on the cornea when using each contact lens/solution combination. |  | Over 2 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To quantify comfort and vision ratings with each lens/solution combination. |  | over 2 days |