Evaluation of Two Different Designs of Bausch & Lomb Contact Lenses

A Study to Evaluate the Product Performance of Two Different Designs of Bausch & Lomb PureVision® Contact Lenses

The objective of this one month study is to evaluate the product performance of a redesigned PureVision Contact Lens compared to the PureVision Contact Lens when worn on a daily wear basis by wearers of contact lenses.

Study Overview

• Status: Completed
• Conditions: Myopia
• Intervention / Treatment: Device: Redesigned Purevision Contact Lens; Device: PureVision Contact Lens

• Study Type: Interventional
• Enrollment (Actual): 376
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Rochester, New York, United States, 14609
      • Bausch & Lomb

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older 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 adapted wearers of one of the listed contact lenses
• Subjects must be myopic
• Subjects must use a lens care system on a regular basis.

Exclusion Criteria:

• Subjects who have worn gas permeable (GP) contact lenses within the last 30 days of polymethylmethacrylate (PMMA) lenses within the last 3 months.
• Subjects with any systemic disease affecting ocular health.
• 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 are using any ocular medication.
• Subjects with any "Present" finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear.
• Subjects who have had any corneal surgery (eg, refractive surgery).
• Subjects who have participated in any drug or device clinical investigation within two weeks prior to entry into this study and/or during the period of study participation.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Redesigned Purevision Contact Lens; Redesigned Bausch & Lomb PureVision contact lens	Device: Redesigned Purevision Contact Lens; Lenses will be dispensed at screening visit, subjects will wear lenses on a daily wear basis for one month.
Active Comparator: PureVision Contact Lens; Bausch & Lomb PureVision contact lens	Device: PureVision Contact Lens; Lenses will be dispensed at screening visit, subjects will wear lenses on a daily wear basis for one month.

What is the study measuring?

Primary 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 and 100 denoting the most favorable rating. The generic scale was comprised of 14 separate questions, where each assessed the denoted symptom/complaint with a score between 0 and 100. The total score was not calculated.	1 month

Secondary 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).	1 month
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.	1 month

Collaborators and Investigators

• Sponsor: Bausch & Lomb Incorporated
• Investigators: Study Director: Gerard Cairns, MCOptom, PhD, Bausch & Lomb Incorporated

Study record dates

Study Major Dates

• Study Start: May 1, 2010
• Primary Completion (Actual): June 1, 2010
• Study Completion (Actual): July 1, 2010

Study Registration Dates

• First Submitted: April 30, 2010
• First Submitted That Met QC Criteria: May 5, 2010
• First Posted (Estimate): May 6, 2010

Study Record Updates

• Last Update Posted (Actual): October 6, 2020
• Last Update Submitted That Met QC Criteria: September 11, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: contact lens
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: 648