The Effects of Azithromycin Ophthalmic Solution, 1% Versus Placebo in Subjects With Blepharitis During a Four-Week Treatment Period (P08638)
2 other identifiers
interventional
314
1 country
26
Brief Summary
The objective of this study is to compare the safety and efficacy of azithromycin ophthalmic solution, 1% versus placebo over a four-week treatment period.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started May 2009
Shorter than P25 for phase_2
26 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
May 1, 2009
CompletedFirst Submitted
Initial submission to the registry
May 5, 2009
CompletedFirst Posted
Study publicly available on registry
May 7, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedNovember 21, 2013
October 1, 2013
7 months
May 5, 2009
October 29, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Eyelid margin erythema
Four weeks
Secondary Outcomes (1)
Signs and symptoms of Blepharitis
One week, two weeks, three weeks, four weeks, six weeks, eight weeks
Study Arms (2)
1
EXPERIMENTAL2
PLACEBO COMPARATORInterventions
One drop in each eye twice a day for the first two days; then one drop in each eye once a day for 26 days
One drop in each eye twice a day for the first two days; then one drop in each eye once a day for 26 days
Eligibility Criteria
You may qualify if:
- Have best corrected visual acuity in both eyes of at least +0.7 or better
- If female, are non-pregnant or non-lactating
- Have a current diagnosis of blepharitis in one or both eyes
You may not qualify if:
- Have lid structural abnormalities
- Have suspected ocular fungal or viral infection
- Have practiced warm compress therapy within 14 days prior to Visit 2
- Unable to withhold the use of contact lenses during the treatment or follow-up periods
- Unable to withhold the use of ocular cosmetic products within 24 hours prior to study visits
- Have had penetrating intraocular surgery within 90 days prior to Visit 2
- Have had ocular surface surgery within the past year prior to Visit 2
- Have a serious medical condition which could confound study assessments
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (26)
Schwartz Laser Eye Center
Scottsdale, Arizona, 85260, United States
McDonald Eye Associates
Fayetteville, Arkansas, 72703, United States
Sall Research Medical Center, Inc.
Artesia, California, 90701, United States
Sall Research Medical Center
Artesia, California, 90701, United States
United Medical Research Company
Inglewood, California, 90301, United States
North Valley Eye Medical Group
Mission Hills, California, 91345, United States
Coastal Vision Medical Group
Newport Beach, California, 92660, United States
West Coast Eye Care
San Diego, California, 92115-1754, United States
Hernando Eye Institute
Brooksville, Florida, 34613, United States
Center for Excellence in Eye Care
Miami, Florida, 33176, United States
Wohl Eye Center
Bloomingdale, Illinois, 60108, United States
Thomas John Vision Institute
Tinley Park, Illinois, 60477, United States
Grene Vision Group
Wichita, Kansas, 67208, United States
Taustine Eye Center
Louisville, Kentucky, 40217, United States
Eastern Maine Medical Center
Bangor, Maine, 04401, United States
Ophthalmology Associates
St Louis, Missouri, 63131, United States
Comprehensive Eye Care Ltd
Washington, Missouri, 63090, United States
David M. Ringel, DO, PA
Sewell, New Jersey, 08080, United States
Brar-Parekh Eye Associates
Woodland Park, New Jersey, 07424, United States
Ophthalmic Consultants of Long Island
Lynbrook, New York, 11563, United States
Park Ophthalmology
Durham, North Carolina, 27713, United States
Ohio State University - College of Optometry
Columbus, Ohio, 43210, United States
Columbus Ophthalmology Associates
Columbus, Ohio, 43213, United States
Philadelphia Eye Associates
Philadelphia, Pennsylvania, 19148, United States
Total Eye Care, PA
Memphis, Tennessee, 38119, United States
Eye Clinics of South Texas
San Antonio, Texas, 78209, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Reza Haque, MD,PhD
Medical Monitor, Inspire
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 5, 2009
First Posted
May 7, 2009
Study Start
May 1, 2009
Primary Completion
December 1, 2009
Study Completion
December 1, 2009
Last Updated
November 21, 2013
Record last verified: 2013-10