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
International
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 Up to 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 up to 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 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).
Percentage of Patients With Microbiological Cure Up to Day 6
Percentage of patients with microbiological cure, defined such that all bacteria present in the study eye at Day 1 (Baseline) are eradicated up to 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 Up to Day 6
Percentage of patients with clinical improvement of ocular signs up to 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 Up to Day 6
Percentage of patients with clinical improvement of ocular symptoms, defined as a decrease (improvement) up to Day 6 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
NCT00518089
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
April 2019
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
January 2009 (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
859 (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 Up to 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 up to 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
6 Days
Secondary 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
Title
Percentage of Patients With Microbiological Cure Up to 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 up to 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
6 Days
Title
Percentage of Patients With Clinical Improvement of Ocular Signs Up to Day 6
Description
Percentage of patients with clinical improvement of ocular signs up to 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
6 Days
Title
Percentage of Patients With Clinical Improvement of Ocular Symptoms Up to Day 6
Description
Percentage of patients with clinical improvement of ocular symptoms, defined as a decrease (improvement) up to Day 6 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
6 Days
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
Downey
State/Province
California
Country
United States
City
Rajajinagar
State/Province
Bangalore
Country
India
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
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A Study of the Safety and Efficacy of Gatifloxacin in Patients With Bacterial Conjunctivitis
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