A Study of the Safety and Efficacy of Gatifloxacin in Patients With Bacterial Conjunctivitis
1 other identifier
interventional
578
1 country
1
Brief Summary
The study will determine the safety and efficacy of gatifloxacin eye drops in patients with bacterial conjunctivitis
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Aug 2007
Shorter than P25 for phase_3
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
July 30, 2007
CompletedFirst Posted
Study publicly available on registry
August 1, 2007
CompletedStudy Start
First participant enrolled
August 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2008
CompletedResults Posted
Study results publicly available
November 30, 2011
CompletedNovember 30, 2011
October 1, 2011
10 months
July 30, 2007
June 15, 2010
October 24, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Patients With Clearing (Clinical Success) of Conjunctival Hyperemia and Conjunctival Discharge at Day 6
Percentage of patients that achieved clinical success, defined as achievement of a score of zero for both conjunctival hyperemia and conjunctival discharge in the study eye at Day 6. Conjunctival hyperemia and conjunctival discharge were each assessed on a 4-point severity grade scale (0=none, +1=mild, +2=moderate, +3=severe).
Day 6
Secondary Outcomes (3)
Percentage of Patients With Microbiological Cure at Day 6
Day 6
Percentage of Patients With Clinical Improvement of Ocular Signs at Day 6
Day 6
Percentage of Patients With Clinical Improvement of Ocular Symptoms at Day 6
Day 6
Study Arms (2)
Gatifloxacin 0.5% Eye Drops
EXPERIMENTALGatifloxacin 0.5% Eye Drops
Placebo Eye Drops
PLACEBO COMPARATORPlacebo Eye Drops
Interventions
Day 1 = 1 drop of study medication every 2hrs up to 8 times total; day 2-5 = 1 drop twice daily
Day 1 = 1 drop of study medication every 2hrs up to 8 times total; day 2-5 = 1 drop twice daily
Eligibility Criteria
You may qualify if:
- Clinically diagnosed with bacterial conjunctivitis
You may not qualify if:
- Signs and/or symptoms of conjunctivitis for more than 96 hours
- Signs and/or symptoms suggestive of fungal, viral, or allergic conjunctivitis
- Clinical diagnosis of chlamydia in either eye
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Allerganlead
Study Sites (1)
Unknown Facility
Gretna, Louisiana, United States
Related Publications (1)
Heller W, Cruz M, Bhagat YR, De Leon JM, Felix C, Villanueva L, Hollander DA, Jensen H. Gatifloxacin 0.5% administered twice daily for the treatment of acute bacterial conjunctivitis in patients one year of age or older. J Ocul Pharmacol Ther. 2014 Dec;30(10):815-22. doi: 10.1089/jop.2014.0040.
PMID: 25244402DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Therapeutic Area Head
- Organization
- Allergan, Inc.
Study Officials
- STUDY DIRECTOR
Medical Director
Allergan
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- 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
July 30, 2007
First Posted
August 1, 2007
Study Start
August 1, 2007
Primary Completion
June 1, 2008
Study Completion
June 1, 2008
Last Updated
November 30, 2011
Results First Posted
November 30, 2011
Record last verified: 2011-10