A Study of the Safety and Efficacy of Gatifloxacin in Patients With Bacterial Conjunctivitis

Phase 3

Completed

• Conditions: Bacterial Conjunctivitis
• Interventions: Drug: Gatifloxacin 0.5% eye drops; Drug: placebo eye drops

• Registration Number: NCT00518089
• Lead Sponsor: Allergan

Brief Summary

The study will determine the safety and efficacy of gatifloxacin eye drops in patients with bacterial conjunctivitis

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-08-16
• Study First Submitted QC: 2007-08-16
• Study First Posted: 2007-08-20
• Study Start: 2008-02
• Primary Completion: 2009-01
• Study Completion: 2009-01
• Disposition First Submitted: 2009-11-30
• Disposition First Submitted QC: 2009-11-30
• Disposition First Posted: 2009-12-02
• Results First Submitted: 2010-06-15
• Results First Submitted QC: 2011-10-24
• Results First Posted: 2011-11-30
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-10
• Last Update Posted: 2019-04-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 859

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Gatifloxacin 0.5% Eye Drops	Gatifloxacin 0.5% eye drops	Gatifloxacin 0.5% Eye Drops
Placebo Eye Drops	placebo eye drops	Placebo Eye Drops

Primary Outcome Measures

Name	Time	Method
Percentage of Patients With Clearing (Clinical Success) of Conjunctival Hyperemia and Conjunctival Discharge Up to Day 6	6 Days	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

Name	Time	Method
Percentage of Patients With Clearing (Clinical Success) of Conjunctival Hyperemia and Conjunctival Discharge at Day 6	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	6 Days	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	6 Days	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	6 Days	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.