Evaluation of a Multi-Purpose Solution

Not Applicable

Completed

• Conditions: Contact Lens Solutions
• Interventions: Device: Bausch & Lomb Multi-Purpose Solution

• Registration Number: NCT00710879
• Lead Sponsor: Bausch & Lomb Incorporated

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-06-30
• Study Start: 2008-07
• Study First Submitted QC: 2008-07-07
• Study First Posted: 2008-07-08
• Primary Completion: 2009-02
• Study Completion: 2009-02
• Results First Submitted: 2011-01-14
• Results First Submitted QC: 2011-01-14
• Results First Posted: 2011-02-08
• Status Verified: 2011-12
• Last Update Submitted: 2011-12-07
• Last Update Posted: 2011-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Multipurpose Solution	Bausch & Lomb Multi-Purpose Solution	Multi-purpose solution administered to adapted FDA group I soft contact lens wearers and FDA group IV soft contact lens wearers.

Primary Outcome Measures

Name	Time	Method
Antimicrobial Efficacy	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 Outcome Measures

Name	Time	Method
Solution Related AE's and Lens Changes	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	3 months, 6 months	The Utility was determined based on the results of the efficacy and safety evaluations.

Trial Locations

Locations (1)

Dr. Nicholas Marsico; 🇺🇸 Torrance, California, United States