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

Phase 3CompletedNCT00509873

Allergan578 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

578

Conditions

Bacterial Conjunctivitis

Interventions

Gatifloxacin 0.5% eye dropsDRUG

Day 1 = 1 drop of study medication every 2hrs up to 8 times total; day 2-5 = 1 drop twice daily

placebo eye dropsDRUG

Day 1 = 1 drop of study medication every 2hrs up to 8 times total; day 2-5 = 1 drop twice daily

Eligibility

Sex: ALLMin age: 1 Year

Medical Language ↔ Plain English

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

Locations (1)

Unnamed facility

Gretna, Louisiana, United States

Outcomes

Primary Outcomes

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).

Time frame: Day 6

Secondary Outcomes

Percentage of Patients With Microbiological Cure at Day 6

Percentage of patients with microbiological cure, defined such that all bacteria present in the study eye at Day 1 (Baseline) are eradicated (or absent) at 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: Day 6

Percentage of Patients With Clinical Improvement of Ocular Signs at Day 6

Percentage of patients with clinical improvement of ocular signs at 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: Day 6

Percentage of Patients With Clinical Improvement of Ocular Symptoms at Day 6

Percentage of patients with clinical improvement of ocular symptoms at Day 6, defined as a decrease (improvement) 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

Data from ClinicalTrials.gov

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