Evaluation of a Multi-Purpose Solution

Contact Lens Solutions Clinical Trial

Official title:

A Study to Evaluate the Clinical Performance of a Multi-Purpose Solution.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00710879
• Other study ID #: 568
• Status: Completed
• Phase: N/A
• First received: June 30, 2008
• Last updated: December 7, 2011
• Start date: July 2008
• Est. completion date: February 2009

Study information

• Verified date: December 2011
• Source: Bausch & Lomb Incorporated
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: February 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Contact Lens Solutions

Intervention

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

Locations

Country	Name	City	State
United States	Dr. Nicholas Marsico	Torrance	California

Sponsors (1)

Lead Sponsor	Collaborator
Bausch & Lomb Incorporated

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Antimicrobial Efficacy	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	2 weeks, 3 months	No
Secondary	Solution Related AE's and Lens Changes	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.	3 months, 6 months	Yes
Secondary	Solution Utlility	The Utility was determined based on the results of the efficacy and safety evaluations.	3 months, 6 months	No