Back to resultsA Study of the Safety and Efficacy of Gatifloxacin in Patients With Bacterial Conjunctivitis
Primary Purpose
Bacterial Conjunctivitis
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Gatifloxacin 0.5% eye drops
placebo eye drops
Sponsored by
About this trial
This is an interventional treatment trial for Bacterial Conjunctivitis
Eligibility Criteria
Inclusion Criteria:
- Clinically diagnosed with bacterial conjunctivitis
Exclusion Criteria:
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Gatifloxacin 0.5% Eye Drops
Placebo Eye Drops
Arm Description
Gatifloxacin 0.5% Eye Drops
Placebo Eye Drops
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Percentage of Patients With Microbiological Cure at Day 6
Percentage of patients with microbiological cure, defined such that all bacteria present in the study eye at Day 1 (Baseline) are eradicated (or absent) at Day 6 based on a Classification of Microbial Response. (Eradication=pathogen is absent in follow-up culture; Reduction=pathogen is reduced from baseline below threshold count in follow-up culture; Persistence=pathogen reduced from baseline but is above or equal to threshold count in follow-up culture; and Proliferation=pathogen has increased in count from baseline in follow-up culture)
Percentage of Patients With Clinical Improvement of Ocular Signs at Day 6
Percentage of patients with clinical improvement of ocular signs at Day 6 based on a 4-point scale (0 = none, 1 = mild, 2 = moderate, and 3 = severe), defined as a decrease (improvement) from Day 1 (Baseline) in the total score of conjunctival hyperemia and mucopurulent discharge (pus),with no increase (worsening) from Day 1 (Baseline) in either individual variable in the study eye.
Percentage of Patients With Clinical Improvement of Ocular Symptoms at Day 6
Percentage of patients with clinical improvement of ocular symptoms at Day 6, defined as a decrease (improvement) from Day 1 (Baseline) in the total score of itching and tearing (each on 4-point scale: 0 = none, 1 = mild, 2 = moderate, and 3 = severe), with no increase (worsening) from Day 1 (Baseline) in any individual score in the study eye diagnosed with bacterial conjunctivitis
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00509873
Brief Title
A Study of the Safety and Efficacy of Gatifloxacin in Patients With Bacterial Conjunctivitis
Study Type
Interventional
2. Study Status
Record Verification Date
October 2011
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
June 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allergan
4. Oversight
5. Study Description
Brief Summary
The study will determine the safety and efficacy of gatifloxacin eye drops in patients with bacterial conjunctivitis
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bacterial Conjunctivitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
578 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Gatifloxacin 0.5% Eye Drops
Arm Type
Experimental
Arm Description
Gatifloxacin 0.5% Eye Drops
Arm Title
Placebo Eye Drops
Arm Type
Placebo Comparator
Arm Description
Placebo Eye Drops
Intervention Type
Drug
Intervention Name(s)
Gatifloxacin 0.5% eye drops
Intervention Description
Day 1 = 1 drop of study medication every 2hrs up to 8 times total; day 2-5 = 1 drop twice daily
Intervention Type
Drug
Intervention Name(s)
placebo eye drops
Intervention Description
Day 1 = 1 drop of study medication every 2hrs up to 8 times total; day 2-5 = 1 drop twice daily
Primary Outcome Measure Information:
Title
Percentage of Patients With Clearing (Clinical Success) of Conjunctival Hyperemia and Conjunctival Discharge at Day 6
Description
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).
Time Frame
Day 6
Secondary Outcome Measure Information:
Title
Percentage of Patients With Microbiological Cure at Day 6
Description
Percentage of patients with microbiological cure, defined such that all bacteria present in the study eye at Day 1 (Baseline) are eradicated (or absent) at Day 6 based on a Classification of Microbial Response. (Eradication=pathogen is absent in follow-up culture; Reduction=pathogen is reduced from baseline below threshold count in follow-up culture; Persistence=pathogen reduced from baseline but is above or equal to threshold count in follow-up culture; and Proliferation=pathogen has increased in count from baseline in follow-up culture)
Time Frame
Day 6
Title
Percentage of Patients With Clinical Improvement of Ocular Signs at Day 6
Description
Percentage of patients with clinical improvement of ocular signs at Day 6 based on a 4-point scale (0 = none, 1 = mild, 2 = moderate, and 3 = severe), defined as a decrease (improvement) from Day 1 (Baseline) in the total score of conjunctival hyperemia and mucopurulent discharge (pus),with no increase (worsening) from Day 1 (Baseline) in either individual variable in the study eye.
Time Frame
Day 6
Title
Percentage of Patients With Clinical Improvement of Ocular Symptoms at Day 6
Description
Percentage of patients with clinical improvement of ocular symptoms at Day 6, defined as a decrease (improvement) from Day 1 (Baseline) in the total score of itching and tearing (each on 4-point scale: 0 = none, 1 = mild, 2 = moderate, and 3 = severe), with no increase (worsening) from Day 1 (Baseline) in any individual score in the study eye diagnosed with bacterial conjunctivitis
Time Frame
Day 6
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Clinically diagnosed with bacterial conjunctivitis
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
City
Gretna
State/Province
Louisiana
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
25244402
Citation
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.
Results Reference
derived
Learn more about this trial
A Study of the Safety and Efficacy of Gatifloxacin in Patients With Bacterial Conjunctivitis
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