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

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

Study Overview

• Status: Completed
• Conditions: Bacterial Conjunctivitis
• Intervention / Treatment: Drug: gatifloxacin; Drug: moxifloxacin 0.5% eye drops

• Study Type: Interventional
• Enrollment (Actual): 171
• Phase: Phase 4

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Whitby, Ontario, Canada
• United States
  • California
    • Sacramento, California, United States

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 1 month (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1	Drug: gatifloxacin; Day 1-6 = 1 drop of study medication three times a day; Other Names: Zymar®
Active Comparator: 2	Drug: gatifloxacin; Day 1-6 = 1 drop of study medication three times a day; Other Names: Zymar®; Drug: moxifloxacin 0.5% eye drops; Day 1-6 = 1 drop of study medication three times a day; Other Names: Vigamox®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Patients With Clearing (Clinical Success) of Conjunctival Erythema and Conjunctival Discharge at 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).	Day 7

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Patients With Microbiological Improvement	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).	Day 7
Percentage of Patients With Improvement in Ocular Signs for Lid Erythema	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).	Days 7
Percentage of Patients With Improvement in Ocular Signs for Conjunctival Discharge at 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).	Day 7

Collaborators and Investigators

• Sponsor: Allergan

Study record dates

Study Major Dates

• Study Start: June 1, 2007
• Primary Completion (Actual): September 1, 2008
• Study Completion (Actual): September 1, 2008

Study Registration Dates

• First Submitted: April 19, 2007
• First Submitted That Met QC Criteria: April 19, 2007
• First Posted (Estimate): April 23, 2007

Study Record Updates

• Last Update Posted (Estimate): September 21, 2011
• Last Update Submitted That Met QC Criteria: August 17, 2011
• Last Verified: August 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Eye Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Conjunctival Diseases; Eye Infections, Bacterial; Eye Infections; Conjunctivitis; Conjunctivitis, Bacterial; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Anti-Bacterial Agents; Pharmaceutical Solutions; Moxifloxacin; Ophthalmic Solutions; Gatifloxacin
• Other Study ID Numbers: 198782-003