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

October 24, 2011 updated by: Allergan
The study will determine the safety and efficacy of gatifloxacin eye drops in patients with bacterial conjunctivitis

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

578

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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 at Day 6
Time Frame: 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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Allergan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2007

Primary Completion (ACTUAL)

June 1, 2008

Study Completion (ACTUAL)

June 1, 2008

Study Registration Dates

First Submitted

July 30, 2007

First Submitted That Met QC Criteria

July 30, 2007

First Posted (ESTIMATE)

August 1, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

November 30, 2011

Last Update Submitted That Met QC Criteria

October 24, 2011

Last Verified

October 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 198782-004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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