A Study to Evaluate the Safety and Efficacy of Gatifloxacin for the Treatment of Bacterial Conjunctivitis

Phase 4

Completed

• Conditions: Bacterial Conjunctivitis
• Interventions: Drug: gatifloxacin; Drug: moxifloxacin 0.5% eye drops

• Registration Number: NCT00464438
• Lead Sponsor: Allergan

Brief Summary

This is a 7 day study to evaluate the safety and efficacy of topical gatifloxacin ophthalmic solution for the treatment of bacterial conjunctivitis in subjects from birth to 31 days of age

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-04-19
• Study First Submitted QC: 2007-04-19
• Study First Posted: 2007-04-23
• Study Start: 2007-06
• Primary Completion: 2008-09
• Study Completion: 2008-09
• Disposition First Submitted: 2009-09-22
• Disposition First Submitted QC: 2009-09-22
• Disposition First Posted: 2009-09-24
• Results First Submitted: 2010-06-15
• Status Verified: 2011-08
• Results First Submitted QC: 2011-08-17
• Last Update Submitted: 2011-08-17
• Results First Posted: 2011-09-21
• Last Update Posted: 2011-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 171

Inclusion Criteria

• diagnosed with bacterial conjunctivitis

Exclusion Criteria

• chemical or foreign body trauma to either eye
• infection in either eye (besides bacterial conjunctivitis)
• white spots in the cornea or ulcers in either eye
• clinical diagnosis of chlamydia or gonorrhea in either eye

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	moxifloxacin 0.5% eye drops	-
1	gatifloxacin	-
2	gatifloxacin	-

Primary Outcome Measures

Name	Time	Method
Percentage of Patients With Clearing (Clinical Success) of Conjunctival Erythema and Conjunctival Discharge at Day 7	Day 7	Percentage of patients that achieved clinical success, defined as a score of 0 for both conjunctival erythema and conjunctival discharge at Day 7. Conjunctival erythema 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 Microbiological Improvement	Day 7	Percentage of patients with microbiological improvement, defined such that all bacteria present above threshold at Day 1 (Baseline) are eradicated (absent) or reduced at Day 7 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 Improvement in Ocular Signs for Lid Erythema	Days 7	Percentage of patients with at least a 1-grade improvement in ocular signs for lid erythema at Day 7 from Day 1 (Baseline). Lid erythema was assessed on a 4-point severity grade scale (0=none, +1=mild, +2=moderate, +3=severe).
Percentage of Patients With Improvement in Ocular Signs for Conjunctival Discharge at Day 7	Day 7	Percentage of patients with at least a 1-grade improvement in ocular signs for conjunctival discharge at Day 7 from Day 1 (Baseline). Conjunctival discharge was assessed on a 4-point severity grade scale (0=none, +1=mild, +2=moderate,; +3=severe).