A Study to Evaluate the Safety and Efficacy of a New Silicone Hydrogel Contact Lens Design

Not Applicable

Completed

• Conditions: Myopia
• Interventions: Device: B&L Investigational Contact Lens; Device: B&L PureVision Contact Lens

• Registration Number: NCT01449526
• Lead Sponsor: Bausch & Lomb Incorporated

Brief Summary

The objective of this study is to evaluate the safety and efficacy of a new silicone hydrogel contact lens compared to the Bausch + Lomb PureVision contact lens when worn by adapted soft contact lens wearers.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-08
• Study First Submitted: 2011-10-06
• Study First Submitted QC: 2011-10-06
• Study First Posted: 2011-10-10
• Primary Completion: 2011-12
• Study Completion: 2012-01
• Results First Submitted: 2014-03-28
• Status Verified: 2015-02
• Results First Submitted QC: 2015-02-13
• Last Update Submitted: 2015-02-13
• Results First Posted: 2015-02-18
• Last Update Posted: 2015-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 166

Inclusion Criteria

• Subjects must have clear central corneas and be free of any anterior segment disorders.
• Subjects must be myopic, and wear contact lenses in each eye.
• Subjects must be adapted soft contact lens wearers and agree to wear their study lenses on a daily wear basis for approximately 3 months.

Exclusion Criteria

• Subjects who are older than age 40 on the date the informed consent (ICF) is signed.
• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B&L Investigational Contact Lens	B&L Investigational Contact Lens	The Bausch + Lomb investigational silicone hydrogel contact lens
B&L PureVision Contact Lens	B&L PureVision Contact Lens	The Bausch + Lomb PureVision silicone hydrogel contact lens

Primary Outcome Measures

Name	Time	Method
Visual Acuity (VA)	4 visits over 3 months	Mean high contrast, distance logMAR VA for each eye between the Test and Control lenses. This measure is an average from 4 visits taking place over 3 months.

Secondary Outcome Measures

Name	Time	Method
Slit Lamp > Grade 2	3 months	Proportion of eyes with any slit lamp findings greater than grade 2 at any visit between the Test and Control lenses.