Comparison of a New Abbott Medical Optics (AMO) Multi-Purpose Solution (MPS) to Existing Contact Lens Regimens

Study Overview
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Brief Summary
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Crossover clinical evaluation three contact lens care regimens used for one month with Acuvue Oasys lenses.

Detailed Description
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This is a three-arm crossover clinical evaluation of 40 subjects who will use each of three contact lens care regimens for one month with Acuvue Oasys lenses. The subjects will be randomized on the order of solutions used: Investigational MPS, ClearCare, and Opti-Free RepleniSH MPS.

Official Title
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Comparison of a New AMO MPS to Existing Contact Lens Regimens

Conditions
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Normal Contact Lens Wearers

Intervention / Treatment
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* Device: Multi-purpose disinfecting solution
* Device: Clear Care
* Device: Opti-Free RepleniSH


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Is at least 17 years of age and has full legal capacity to volunteer; Has read and signed an information consent letter; Is willing and able to follow instructions and maintain the appointment schedule; Has had an ocular examination in the last two years; Is a current soft lens wearer using either two-week or monthly replacement lenses; Is correctable to a visual acuity of 6/7.5 (20/25) or better (both eyes) with their habitual vision correction (either spectacles or contact lenses); Has normal binocular vision (no strabismus, no amblyopia); Has clear corneas and no active ocular disease; Has a distance contact lens prescription between +8.00 diopters (D) to -12.00 D and a successful fit with the study lenses; Has astigmatism less than or equal to -1.00 D; Agrees to wear the study lenses on a daily wear basis. Exclusion Criteria: Has any active ocular disease; Has any clinically significant lid, conjunctival, or corneal abnormalities that may affect a study outcome variable; Has undergone corneal refractive surgery; Has a systemic condition that may affect a study outcome variable; Is using any systemic or topical medications that may affect ocular health; Has known sensitivity to the diagnostic pharmaceuticals to be used in the study; Is pregnant or lactating; Is participating in any other clinical or research study that may affect a study outcome variable; Currently wears daily disposable lenses or extended wear lenses.

Ages Eligible for Study
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Minimum Age: 17 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: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Investigational MPS<br>AMO Investigational MPS. | Device: Multi-purpose disinfecting solution<br>* For the cleaning, rinsing, and storage of soft contact lenses.<br>|
| Active Comparator: Clear Care<br>Peroxide-based lens care regimen. | Device: Clear Care<br>* Peroxide-based regimen for cleaning and disinfecting soft contact lenses.<br>|
| Active Comparator: Opti-Free RepleniSH<br>Multi-purpose disinfecting solution (Alcon). | Device: Opti-Free RepleniSH<br>* Multi-purpose disinfecting solution for the cleaning, rinsing and storing of soft contact lenses.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Corneal Staining | Corneal staining will be assessed with sodium fluorescein dye on the ocular surface. The cornea is split into 5 sections, each section is evaluated by staining type, depth, and extent is graded on a 0 to 100 scale with higher scores indicating more staining. The possible total range for the total score per eye is 0 to 50,000 (100x100x100=10,000 per section) with values higher than 1200 being clinically relevant. | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective Lens Wearing Comfort | This will be assessed by a questionnaire on patient-perceived lens comfort and any symptoms of discomfort on a 0 to 100 scale. | 4 weeks | 
| Dryness | This will be assessed by the tear break-up time on the lens surface, measured in seconds. | 4 weeks |