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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Additional relevant MeSH terms:
Pharmaceutical Solutions
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014