A Study to Evaluate the Performance of Two Designs of Soft Toric Lenses

Study Overview
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Brief Summary
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The objective of the study is to evaluate the product performance of the Bausch + Lomb toric investigational contact lenses compared to the currently marketed PureVision toric contact lenses.

Official Title
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A Study to Evaluate the Performance of Two Designs of Soft Toric Lenses

Conditions
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Myopia

Intervention / Treatment
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* Device: Investigational Toric Lens
* Device: PureVision Toric 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 lens wearers, 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 Subjects must be habitual wearers of toric soft contact lenses. Exclusion Criteria: Subjects with any systemic disease currently affecting ocular health or which in the Investigator's opinion may have an effect on ocular health during the course of the study. 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 who are using any ocular medication. Subjects with any grade 2 or greater finding during the slit lamp examination. Subjects with corneal infiltrates, of ANY GRADE, are not eligible. Subjects with any Present finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear. Subjects who are allergic to any component in the study care products.

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

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Investigational Toric Lens<br>Bausch + Lomb investigational toric contact lenses | Device: Investigational Toric Lens<br>* Bausch & Lomb investigational toric contact lens worn on a daily wear basis for 2 weeks.<br>|
| Active Comparator: PureVision Toric Lens<br>Currently marketed Bausch + Lomb PureVision toric contact lenses | Device: PureVision Toric Lens<br>* Currently marked Bausch & Lomb PureVision Toric Lens worn on a daily wear basis for 2 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Eyes With Absolute Lens Rotation ≤ 10 Degrees. |  | 2 weeks | 
| Visual Acuity | Visual acuity was assessed by distance high contrast logarithm of the minimum angle of resolution (logMAR). | 2 weeks | 

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 at each post-dispensing visit based on the subject's experience with the study lens worn prior to the visit. The symptoms/complaints parameters were: Burning/stinging upon insertion; Comfort upon insertion, Overall comfort, and Comfort at the end of the day; Ease of handling/insertion, and Ease of handling/removal; Dryness; Itchiness; Redness; Vision; Lens cleanliness; and Overall impression. | 2 weeks | 
| Percentage of Eyes With > Grade 2 Slit Lamp Findings | Graded slit lamp findings for each eye, including epithelial edema, epithelial microcysts, corneal staining, limbal and bulbar injections, upper lid tarsal conjunctival abnormalities, corneal neovascularization, and corneal infiltrates were graded for severity on a scale from 0 (No Finding) to 4 (Severe Finding). The outcome measure is any finding > grade 2, across abnormalities. | 2 weeks |