Evaluation of a Multi-Purpose Solution

Overview

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

Full Title of Study: “A Study to Evaluate the Clinical Performance of a Multi-Purpose Solution.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: None (Open Label)
  • Study Primary Completion Date: February 2009

Interventions

  • Device: Bausch & Lomb Multi-Purpose Solution
    • Daily care for contact lenses.

Arms, Groups and Cohorts

  • Experimental: Multipurpose Solution
    • Multi-purpose solution administered to adapted FDA group I soft contact lens wearers and FDA group IV soft contact lens wearers.

Clinical Trial Outcome Measures

Primary Measures

  • 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

Secondary Measures

  • 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.
  • Solution Utlility
    • Time Frame: 3 months, 6 months
    • The Utility was determined based on the results of the efficacy and safety evaluations.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Bausch & Lomb Incorporated
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Bev Barna, Study Director, Bausch & Lomb Incorporated

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