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

Allergan171 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

171

Conditions

Bacterial Conjunctivitis

Interventions

gatifloxacinDRUG

Day 1-6 = 1 drop of study medication three times a day

moxifloxacin 0.5% eye dropsDRUG

Day 1-6 = 1 drop of study medication three times a day

Eligibility

Sex: ALLMax age: 31 Days

Medical Language ↔ Plain English

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

Locations (2)

Unnamed facility

Sacramento, California, United States

Unnamed facility

Whitby, Ontario, Canada

Outcomes

Primary Outcomes

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).

Time frame: Day 7

Secondary Outcomes

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).

Time frame: 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).

Time frame: 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).

Time frame: Day 7

Data from ClinicalTrials.gov

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