Evaluation of a Multi-Purpose Solution

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT00710879
First received: June 30, 2008
Last updated: December 7, 2011
Last verified: December 2011
  Purpose

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


Condition Intervention
Contact Lens Solutions
Device: Bausch & Lomb Multi-Purpose Solution

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: A Study to Evaluate the Clinical Performance of a Multi-Purpose Solution.

Resource links provided by NLM:


Further study details as provided by Bausch & Lomb Incorporated:

Primary Outcome Measures:
  • Antimicrobial Efficacy [ Time Frame: 2 weeks, 3 months ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Solution Related AE's and Lens Changes [ Time Frame: 3 months, 6 months ] [ Designated as safety issue: Yes ]
    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.

  • Solution Utlility [ Time Frame: 3 months, 6 months ] [ Designated as safety issue: No ]
    The Utility was determined based on the results of the efficacy and safety evaluations.


Enrollment: 180
Study Start Date: July 2008
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00710879

Locations
United States, California
Dr. Nicholas Marsico
Torrance, California, United States, 90505
Sponsors and Collaborators
Bausch & Lomb Incorporated
Investigators
Study Director: Bev Barna Bausch & Lomb Incorporated
  More Information

No publications provided

Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT00710879     History of Changes
Other Study ID Numbers: 568
Study First Received: June 30, 2008
Results First Received: January 14, 2011
Last Updated: December 7, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Bausch & Lomb Incorporated:
Efficacy

ClinicalTrials.gov processed this record on April 15, 2014