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

Not Applicable

Completed

Interventions: Device: PureVision Toric Lens
Device: Investigational Toric Lens

Brief Summary: 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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
PureVision Toric Lens	PureVision Toric Lens	Currently marketed Bausch + Lomb PureVision toric contact lenses
Investigational Toric Lens	Investigational Toric Lens	Bausch + Lomb investigational toric contact lenses

Primary Outcome Measures

Name	Time	Method
Percentage of Eyes With Absolute Lens Rotation ≤ 10 Degrees.	2 weeks
Visual Acuity	2 weeks	Visual acuity was assessed by distance high contrast logarithm of the minimum angle of resolution (logMAR).

Secondary Outcome Measures

Name	Time	Method
Symptoms and Complaints	2 weeks	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.
Percentage of Eyes With > Grade 2 Slit Lamp Findings	2 weeks	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.