Evaluation of a Multi-Purpose Solution
A Study to Evaluate the Clinical Performance of a Multi-Purpose Solution.
1 other identifier
interventional
180
1 country
1
Brief Summary
This study evaluates a multi-purpose solution when used on a daily wear basis by currently adapted soft contact lens wearers.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2008
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 30, 2008
CompletedStudy Start
First participant enrolled
July 1, 2008
CompletedFirst Posted
Study publicly available on registry
July 8, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2009
CompletedResults Posted
Study results publicly available
February 8, 2011
CompletedDecember 13, 2011
December 1, 2011
7 months
June 30, 2008
January 14, 2011
December 7, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (2)
Solution Related AE's and Lens Changes
3 months, 6 months
Solution Utlility
3 months, 6 months
Study Arms (1)
Multipurpose Solution
EXPERIMENTALMulti-purpose solution administered to adapted FDA group I soft contact lens wearers and FDA group IV soft contact lens wearers.
Interventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Dr. Nicholas Marsico
Torrance, California, 90505, United States
Results Point of Contact
- Title
- Joseph Barr, OD, MS
- Organization
- Bausch & Lomb Incorporated
Study Officials
- STUDY DIRECTOR
Bev Barna
Bausch & Lomb Incorporated
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 30, 2008
First Posted
July 8, 2008
Study Start
July 1, 2008
Primary Completion
February 1, 2009
Study Completion
February 1, 2009
Last Updated
December 13, 2011
Results First Posted
February 8, 2011
Record last verified: 2011-12