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

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

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 859
• Phase: Phase 3

Contacts and Locations

Study Locations

• India
  • Bangalore
    • Rajajinagar, Bangalore, India
• United States
  • California
    • Downey, California, United States

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Gatifloxacin 0.5% Eye Drops	Drug: Gatifloxacin 0.5% eye drops; Day 1 = 1 drop of study medication every 2hrs up to 8 times total; day 2-5 = 1 drop twice daily
PLACEBO_COMPARATOR: Placebo Eye Drops	Drug: placebo eye drops; Day 1 = 1 drop of study medication every 2hrs up to 8 times total; day 2-5 = 1 drop twice daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Patients With Clearing (Clinical Success) of Conjunctival Hyperemia and Conjunctival Discharge Up to 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 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).	6 Days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Day 6
Percentage of Patients With Microbiological Cure Up to Day 6	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).	6 Days
Percentage of Patients With Clinical Improvement of Ocular Signs Up to Day 6	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.	6 Days
Percentage of Patients With Clinical Improvement of Ocular Symptoms Up to Day 6	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.	6 Days

Collaborators and Investigators

• Sponsor: Allergan

Publications and helpful links

General Publications

• Heller W, Cruz M, Bhagat YR, De Leon JM, Felix C, Villanueva L, Hollander DA, Jensen H. Gatifloxacin 0.5% administered twice daily for the treatment of acute bacterial conjunctivitis in patients one year of age or older. J Ocul Pharmacol Ther. 2014 Dec;30(10):815-22. doi: 10.1089/jop.2014.0040.

Study record dates

Study Major Dates

• Study Start: February 1, 2008
• Primary Completion (ACTUAL): January 1, 2009
• Study Completion (ACTUAL): January 1, 2009

Study Registration Dates

• First Submitted: August 16, 2007
• First Submitted That Met QC Criteria: August 16, 2007
• First Posted (ESTIMATE): August 20, 2007

Study Record Updates

• Last Update Posted (ACTUAL): April 23, 2019
• Last Update Submitted That Met QC Criteria: April 10, 2019
• Last Verified: April 1, 2019

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; Ophthalmic Solutions; Gatifloxacin
• Other Study ID Numbers: 198782-005