Performance Evaluation of Contact Lenses Among a Population of Adapted Contact Lens Wearers

March 4, 2015 updated by: Bausch & Lomb Incorporated
This study is being conducted to evaluate Bausch & Lomb PureVision Multi-Focal contact lenses compared to the Bausch & Lomb SofLens59 contact lens when worn by adapted soft contact lens wearers on a daily wear basis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

272

Phase

  • Not Applicable

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

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

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

30 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 adapted soft contact lens wearers and agree to wear the study lenses on a daily wear basis for at least eight hours a day for approximately two weeks.
  • Subjects must wear a lens in each eye and each lens must be of the same manufacture and brand.

Exclusion Criteria:

  • Subjects participating in any drug or device clinical investigation within two weeks prior to entry into this study and/or during the period of study participation.
  • Subjects with any systemic disease affecting ocular health
  • Subjects with an active ocular disease or using any ocular medication.
  • Subjects who have had any corneal surgery (eg, refractive surgery).

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PureVision Multi-Focal contact lenses
Device: PureVision Multi-Focal contact lenses
Contact lenses to be worn on a daily wear basis for 2 weeks.
Active Comparator: SofLens59 contact lens
Device: SofLens59 contact lens
Contact lenses to be worn on a daily wear basis for 2 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Distance Visual Acuity (VA) Between Test and Control Lenses Worse Than 20/40.
Time Frame: 2 weeks
Eyes with distance lens VA of 20/40 or worse at study exit between test and control lenses.
2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subjective Ratings of Eye Strain
Time Frame: 2 week visit
Convergence Insufficiency Symptom Survey (CISS), was used to assess eye strain symptoms measured on a scale of 1-4. 0 score=never, 4 score=always
2 week visit

Collaborators and Investigators

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

Sponsor

Bausch & Lomb Incorporated

Investigators

  • Study Director: Beverly J Barna, Bausch & Lomb Incorporated

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

September 1, 2009

Primary Completion (Actual)

November 1, 2009

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

September 25, 2009

First Submitted That Met QC Criteria

September 25, 2009

First Posted (Estimate)

September 28, 2009

Study Record Updates

Last Update Posted (Estimate)

March 24, 2015

Last Update Submitted That Met QC Criteria

March 4, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 630

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.

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