Evaluation of a Multi-Purpose Solution

December 7, 2011 updated by: Bausch & Lomb Incorporated

A Study to Evaluate the Clinical Performance of a Multi-Purpose Solution.

This study evaluates a multi-purpose solution when used on a daily wear basis by currently adapted soft contact lens wearers.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

180

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
    • California
      • Torrance, California, United States, 90505
        • Dr. Nicholas Marsico

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:

  • Is an adapted Group I or Group IV soft contact lens wearer and agrees to wear the study lenses on a daily wear basis.
  • Must be able and willing to comply with all treatment and follow-up study procedures.
  • Must have a clear central cornea.
  • VA correctable to 0.3 LogMar or better (driving vision)

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.
  • Pregnancy

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: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Multipurpose Solution
Multi-purpose solution administered to adapted FDA group I soft contact lens wearers and FDA group IV soft contact lens wearers.
Device: Bausch & Lomb Multi-Purpose Solution
Daily care for contact lenses.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Antimicrobial Efficacy
Time Frame: 2 weeks, 3 months
Excellent = No bacterial infection suspected and no ocular pathogens detected and bacteria of normal flora <0-103 CFU/mL. Good = No bacterial infection suspected and no ocular pathogens detected and bacteria of normal flora <103-105 CFU/mL. Skeptical = Bacterial infection suspected and ocular pathogens detected and bacteria of normal flora ≥ 105 CFU/mL. No Efficacy = Bacterial infection definite and ocular pathogens detected and bacteria of normal flora ≥ 105 CFU/mL. Pathogens were H. aegyptius, H. influenzae, Moraxella spp., P. aeruginosa, S. pneumoniae, S. aureus, N. gonorrhoeae
2 weeks, 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Solution Related AE's and Lens Changes
Time Frame: 3 months, 6 months
Very Safe = No solution related AEs and no changes in lens properties related to the solution. Safe = No solution related AEs and slight change in lens properties related to the solution, but lens wear was continued. Skeptical = Solution related AEs were suspected and lens properties changed due to the solution and lens wear was discontinued. Not Safe = Solution related AEs were present and lens properties changed due to the solution and lens wear was discontinued.
3 months, 6 months
Solution Utlility
Time Frame: 3 months, 6 months
The Utility was determined based on the results of the efficacy and safety evaluations.
3 months, 6 months

Collaborators and Investigators

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

Sponsor

Bausch & Lomb Incorporated

Investigators

  • Study Director: Bev 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

July 1, 2008

Primary Completion (Actual)

February 1, 2009

Study Completion (Actual)

February 1, 2009

Study Registration Dates

First Submitted

June 30, 2008

First Submitted That Met QC Criteria

July 7, 2008

First Posted (Estimate)

July 8, 2008

Study Record Updates

Last Update Posted (Estimate)

December 13, 2011

Last Update Submitted That Met QC Criteria

December 7, 2011

Last Verified

December 1, 2011

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 568

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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