Product Feasibility of a New Silicone Hydrogel Contact Lens

Study Overview
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Brief Summary
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The objective of this study is to determine the clinical feasibility and to evaluate the product performance of investigational contact lens.

Official Title
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A Study to Evaluate the Product Feasibility of a New Silicone Hydrogel Contact Lens

Conditions
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Myopia

Intervention / Treatment
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* Device: Investigational Lens
* Device: Acuvue Oasys Lens
* Device: Air Optix Aqua Lens


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects must have clear central corneas and be free of any anterior segment disorders. Subjects must be adapted wearers of soft contact lenses, wear a lens in each eye, and each lens must be of the same manufacture and brand. Subjects must be myopic and require lens correction Exclusion Criteria: Subjects with any systemic disease affecting ocular health. Subjects using any systemic or topical medications that will, in the Investigator's opinion, affect ocular physiology or lens performance. Subjects with an active ocular disease or are using any ocular medication. Subjects with any Present finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear.

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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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Investigational Lens<br>Bausch & Lomb investigational silicone hydrogel lens. | Device: Investigational Lens<br>* Bausch & Lomb investigational silicone hydrogel lens on a daily wear basis for 1 week.<br>|
| Active Comparator: Acuvue Oasys Lens<br>Johnson & Johnson Acuvue Oasys contact lens. | Device: Acuvue Oasys Lens<br>* Johnson & Johnson Acuvue Oasys contact lens on a daily wear basis for 1 week.<br>|
| Active Comparator: Air Optix Aqua Lens<br>Ciba Vision Air Optix Aqua contact lens. | Device: Air Optix Aqua Lens<br>* Ciba Vision Air Optix Aqua contact lens on a daily wear basis for 1 week.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Acuity (Investigational vs Air Optix Aqua Lens) | The mean difference in distance high contrast logMAR visual acuity(VA) between the investigational lens (RD2117-01) and the Air Optix Aqua control lens. | 1 week | 
| Visual Acuity (Investigational vs Acuvue Oasys Lens) | The mean difference in distance high contrast logMAR visual acuity(VA) between the investigational lens(RD2117-01) and the Acuvue Oasys control lens. | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comfort Throughout the Day (Investigational vs Acuvue Oasys Lens) | The mean differences in comfort between the investigational lens (RD2117-01) and the Acuvue Oasys control lens. Comfort was measured on a scale of 0 to 100, with 100 being the most favorable score. | 1 week | 
| Comfort Throughout the Day (Investigational vs Air Optix Aqua Lens) | The mean differences in comfort between the investigational lens(RD2117-01) and the Air Optix Aqua control lens. Comfort was measured on a scale of 0 to 100, with 100 being the most favorable score. | 1 week |