Comparative Performance of PureVision Lens Designs

December 7, 2011 updated by: Bausch & Lomb Incorporated

A Study to Evaluate the Product Performance of the Redesigned Bausch & Lomb PureVision® Contact Lens (Test) Compared to the Currently Marketed Bausch & Lomb PureVision® Contact Lens (Control) When Worn on an Extended Wear Basis.

The objective of this study is to evaluate the performance of the PureVision Lens designs when worn on a 30-day continuous wear basis

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

206

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Malaysia
      • Johor Bahru, Malaysia, 80400
        • Laser Focus Sdn Bhd, Vision Correction Centre
  • Philippines
      • Makati City, Philippines, 1200
        • Asian Eye Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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:

  • subject is myopic
  • VA correctable to 0.3 logMAR or better (driving vision)
  • Clear central cornea

Exclusion Criteria:

  • Systemic disease affecting ocular health
  • using systemic or topical medications
  • wear monovision, multifocal or toric contact lenses
  • Any grade 2 or greater slit lamp findings

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Purevision Contact Lens #1
PureVision Soft Contact Lens Design (currently marketed)
Device: Currently Marketed PureVision Contact Lens.
Contact lens for continuous wear
Experimental: PureVision Contact Lens #2
Redesign of the currently marketed PureVision soft contact lens.
Device: Alternate Design of the PureVision Contact Lens.
Contact lens for continuous wear

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subjective Responses to Symptoms/Complaints
Time Frame: Measured at screening/dispensing visit, 1 day, 1 week and 1 month follow-up visits
Subjective responses to symptoms/complaints on a scale 0-100, where 100 is the most favorable score. Subjects rated various aspects of lens comfort, vision, and handling. The average of each symptom/complaint over all follow-up visits was assessed as the primary endpoint.
Measured at screening/dispensing visit, 1 day, 1 week and 1 month follow-up visits

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
LogMAR Visual Acuity
Time Frame: Mean over all visits - 1 day, 1 week, 1 month
The mean distance high contrast LogMAR visual acuity (VA) score for test eyes over all visits, determined by the total number of letters correctly identified on the logMAR chart.
Mean over all visits - 1 day, 1 week, 1 month
Lens Characteristics
Time Frame: Over all scheduled visits day 1 - 1 month
Investigators evaluated study lenses, while on eye, for the number of eyes showing 100% wettability, no discoloration, none-light deposits, fully centered centration, and adequate movement.
Over all scheduled visits day 1 - 1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bausch & Lomb Incorporated

Investigators

  • Study Director: Gerard Cairns, MCOptom, PhD, Bausch & Lomb Incorporated
  • Principal Investigator: Benny Chian, MCOptom, Laser Focus Sdn Bhd, Vision Correction Centre
  • Principal Investigator: Harvey Siy Uy, MD, Asian Eye Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2007

Primary Completion (Actual)

February 1, 2008

Study Completion (Actual)

June 1, 2008

Study Registration Dates

First Submitted

April 16, 2008

First Submitted That Met QC Criteria

April 16, 2008

First Posted (Estimate)

April 18, 2008

Study Record Updates

Last Update Posted (Estimate)

December 12, 2011

Last Update Submitted That Met QC Criteria

December 7, 2011

Last Verified

December 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 544

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe