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

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.

Study Overview

• Status: Completed
• Conditions: Myopia
• Intervention / Treatment: Device: B&L Investigational Contact Lens; Device: B&L PureVision Contact Lens

• Study Type: Interventional
• Enrollment (Actual): 166
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: B&L Investigational Contact Lens; The Bausch + Lomb investigational silicone hydrogel contact lens	Device: B&L Investigational Contact Lens; Lenses will be worn on a daily wear basis for 3 months, new lenses dispensed monthly.
Active Comparator: B&L PureVision Contact Lens; The Bausch + Lomb PureVision silicone hydrogel contact lens	Device: B&L PureVision Contact Lens; Lenses will be worn on a daily wear basis for 3 months, new lenses dispensed monthly.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Acuity (VA)	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.	4 visits over 3 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Bausch & Lomb Incorporated
• Investigators: Study Director: Robert Steffen, OD, MS, Bausch & Lomb Incorporated

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (Actual): December 1, 2011
• Study Completion (Actual): January 1, 2012

Study Registration Dates

• First Submitted: October 6, 2011
• First Submitted That Met QC Criteria: October 6, 2011
• First Posted (Estimate): October 10, 2011

Study Record Updates

• Last Update Posted (Estimate): February 18, 2015
• Last Update Submitted That Met QC Criteria: February 13, 2015
• Last Verified: February 1, 2015

More Information

Terms related to this study

• Keywords: contact lens
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: 661