Safety and Efficacy Pilot Study of AzaSite® (Azithromycin) in Subjects With Blepharitis
A Multi-Center, Open-Label, Randomized Pilot Study of the Safety and Efficacy of AzaSite® Ophthalmic Solution, 1% in Combination With Mechanical Therapy Versus Mechanical Therapy Alone in Subjects With Blepharitis
2 other identifiers
interventional
60
1 country
9
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of AzaSite® ophthalmic solution, 1% on signs and symptoms of blepharitis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
9 active sites
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
Study Start
First participant enrolled
February 1, 2008
CompletedFirst Submitted
Initial submission to the registry
February 27, 2008
CompletedFirst Posted
Study publicly available on registry
March 6, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2008
CompletedSeptember 26, 2011
September 1, 2011
7 months
February 27, 2008
September 20, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
change in clinical signs and symptoms associated with blepharitis
4 weeks
Secondary Outcomes (1)
standard ocular safety assessments
4 weeks
Study Arms (2)
1
EXPERIMENTAL2
NO INTERVENTIONInterventions
ophthalmic solution; 1 drop in each eye BID for two days, then 1 drop in each eye QD for \~26 days
Eligibility Criteria
You may qualify if:
- diagnosis of moderate to severe chronic blepharitis
- if female of childbearing potential, are non-pregnant and non-lactating
You may not qualify if:
- had ocular surface surgery (LASIK, refractive, etc.) within the past year
- unwilling to discontinue the use of contact lenses during the study
- have glaucoma
- unable or unwilling to withhold the use of lid scrubs during the study
- have a serious systemic disease or uncontrolled medical condition that in the judgment of the investigator could confound study assessments or limit compliance
- currently using any preserved topical ocular medications (with the exception of unpreserved tear substitutes) at the time of entry into the study or during study participation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
Sall Research Medical Center
Artesia, California, 90701, United States
North Valley Eye Medical Group
Mission Hills, California, 91345, United States
Center for Excellence in Eye Care
Miami, Florida, 33176, United States
Kentuckiana Institute for Eye Research
Louisville, Kentucky, 40207, United States
Tauber Eye Center
Kansas City, Missouri, 64111, United States
Silverstein Eye Centers
Kansas City, Missouri, 64133, United States
South Shore Eye Care, LLP
Wantagh, New York, 11793, United States
Toyos Clinic
Jackson, Tennessee, 38301, United States
Corona Research Consultants, Inc.
El Paso, Texas, 79904, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Reza Haque, MD
Sponsor GmbH
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
February 27, 2008
First Posted
March 6, 2008
Study Start
February 1, 2008
Primary Completion
September 1, 2008
Last Updated
September 26, 2011
Record last verified: 2011-09