A Study to Evaluate the Product Feasibility of Two New Silicone Hydrogel Contact Lenses

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 two RD2135-01 investigational soft contact lenses (Test 1 and Test 2) developed by Bausch + Lomb. The Test lenses will be compared to both Bausch + Lomb PureVision®2 HD (high definition) soft contact lenses and Ciba Vision Air Optix Aqua soft contact lenses when used among currently adapted soft contact lens wearers.

Official Title
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A Study to Evaluate the Product Feasibility of Two New Silicone Hydrogel Contact Lenses

Conditions
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Myopia

Intervention / Treatment
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* Device: B&L RD2135-01 lens C
* Device: B&L RD2135-01 lens D
* Device: PureVision2
* Device: Air Optix Aqua


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings. Be adapted wearers of soft contact lenses, wear a lens in each eye, and each lens must be of the same manufacture and brand. Be correctable through spherocylindrical refraction to 32 letters (0.3 logMAR) or better (distance, high contrast) in each eye. Be myopic and require lens correction from -0.50 diopters (D) to -6.00 D in each eye. Must agree to wear the study lenses on a daily wear basis for the duration of the study. Must be willing to use a lens care system on a regular basis. If the subject requires a Washout Period, the subject must be willing to discontinue contact lens wear and be willing to wear either spectacles or no lenses during this Washout Period. Exclusion Criteria: Not correctable to 32 letters (0.3 logMAR) in each eye with soft spherical contact lenses. Have an active ocular disease, any corneal infiltrative response or are using any ocular medications. Have worn gas permeable (GP) contact lenses within last 30 days or PMMA lenses within last 3 months. Any scar or neovascularization within the central 4mm of the cornea. Any Grade 2 or greater finding during the slit lamp examination, Subjects with corneal infiltrates, of ANY GRADE, are not eligible. Any Present finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear. Anisometropia (spherical equivalent) of greater than 2.00 D. Any systemic disease affecting ocular health. Using any systemic or topical medications that will affect ocular physiology or lens performance. Aphakic. Amblyopic. Allergic to any component in the study products. Have had any corneal surgery (ie, refractive surgery). Currently wear monovision correction, multifocal, or toric contact lenses. Ocular astigmatism greater than 1.00 D in either eye.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: B&L RD2135-01 lens C<br>Investigational Silicone hydrogel soft contact lens | Device: B&L RD2135-01 lens C<br>* Lenses will be worn on a daily wear basis for 1 week. Lens care solution and lens cases will be provided for daily rinsing, cleaning, disinfecting, and storing the lenses. Rewetting drops will be provided for use as needed during the study.<br>|
| Experimental: B&L RD2135-01 lens D<br>Investigational Silicone hydrogel soft contact lens | Device: B&L RD2135-01 lens D<br>* Lenses will be worn on a daily wear basis for 1 week. Lens care solution and lens cases will be provided for daily rinsing, cleaning, disinfecting, and storing the lenses. Rewetting drops will be provided for use as needed during the study.<br>|
| Active Comparator: PureVision2<br>Bausch & Lomb High definition soft contact lenses | Device: PureVision2<br>* Lenses will be worn on a daily wear basis for 1 week. Lens care solution and lens cases will be provided for daily rinsing, cleaning, disinfecting, and storing the lenses. Rewetting drops will be provided for use as needed during the study.<br>|
| Active Comparator: Ciba Vision Air Optix Aqua<br>Ciba Vision Air Optix Aqua soft contact lens | Device: Air Optix Aqua<br>* Lenses will be worn on a daily wear basis for 1 week. Lens care solution and lens cases will be provided for daily rinsing, cleaning, disinfecting, and storing the lenses. Rewetting drops will be provided for use as needed during the study.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Acuity | Visual acuity was assessed by distance high contrast logarithm of the minimum angle of resolution (logMAR). | At 1 week follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptoms and Complaints | Symptoms/complaints were assessed on a scale from 0 to 100, with 0 denoting unfavorable symptoms/complaints. Symptoms/complaints were recorded for each eye based on the participant's experience with their study lenses worn for that respective treatment period. Symptoms/complaints parameters included the following: Burning/stinging upon insertion, Comfort upon insertion, Overall comfort, Comfort at end of day, Ease of handling/insertion, Ease of handling/removal, Dryness, Itchiness, Redness, Vision upon insertion, Vision, Vision in low light, Lens cleanness upon insertion, Lens cleanness upon removal, Lens cleanness, Dryness at end of day, and Overall impression. | At 1 Week follow up |