Comparison of Lens Care Regimens With a Silicone Hydrogel Lens (Emerald)

Study Overview
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Brief Summary
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The purpose of the study is to evaluate and compare, on a daily wear basis, the performance of two contact lens care solutions when used with silicone hydrogel soft contact lenses with regards to comfort and dryness symptoms.

Detailed Description
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The purpose of the study is to evaluate and compare, on a daily wear basis, the performance of two contact lens care solutions when used with silicone hydrogel soft contact lenses with regards to comfort and dryness symptoms by observing changes within the cornea and collecting subjective ratings

Official Title
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Comparison of Lens Care Regimens With a Silicone Hydrogel Lens (Emerald)

Conditions
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Myopia

Intervention / Treatment
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* Drug: ClearCare
* Drug: Optifree Replenish


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 of age and has full legal capacity to volunteer. Has read, understood and signed an information consent letter. Is willing and able to follow instructions and maintain the appointment schedule. Is presently using either bi-weekly or monthly replacement lenses. Has symptoms of ocular dryness as determined by specific pre-screening criteria. Is correctable to a visual acuity of 6/9 or better (in each eye) with their habitual vision correction. Has clear corneas and no active ocular disease. Has had an ocular examination in the last two years. Exclusion Criteria: A person will be excluded from the study if he/she: Is an asymptomatic lens wearer. Is a daily disposable contact lens wearer. Is a current extended wear contact lens wearer. Currently uses one of the study lens care regimens. Has any clinically significant blepharitis. Has undergone corneal refractive surgery. Is aphakic. Has any active ocular disease. Has any systemic disease affecting ocular health. 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 participating in any other type of clinical or research study.

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: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br> | Drug: ClearCare<br>* contact lens care system<br>|
| Active Comparator: 2<br> | Drug: Optifree Replenish<br>* contact lens care system<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| High Contrast Visual Acuity | High Contrast Visual Acuity with contact lenses, was measured using standardized and computer generated logMAR chart. 10 Sloan letters adopted. VA chart's target size varied from logMAR 1.0 to -0.40 in 0.1 logMAR step. | 2 weeks | 
| Low Contrast Visual Acuity | Low Contrast Visual Acuity with contact lenses, was measured using standardized and computer generated logMAR chart. 10 Sloan letters adopted. VA chart's target size varied from logMAR 1.0 to -0.40 in 0.1 logMAR step. | 2 weeks | 
| In-vivo Wettability | Pre-lens non-invasive tear breakup time | 2 weeks | 
| Subjective Comfort Rating | Numeric rating scale was administered. Comfort ratings (0 - 100), 0 = Very poor comfort and 100 = Excellent comfort. | 2 weeks |