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:

MedlinePlus related topics: Eye Wear

U.S. FDA Resources

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

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:

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 June 17, 2013