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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT00509873
First received: July 30, 2007
Last updated: October 24, 2011
Last verified: October 2011
History of Changes
  Purpose

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


Condition Intervention Phase
Bacterial Conjunctivitis
 Drug: Gatifloxacin 0.5% eye drops
Drug: placebo eye drops
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Pinkeye
U.S. FDA Resources

Further study details as provided by Allergan:

Primary Outcome Measures:
  • Percentage of Patients With Clearing (Clinical Success) of Conjunctival Hyperemia and Conjunctival Discharge at Day 6 [ Time Frame: Day 6 ] [ Designated as safety issue: No ]
    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).


Secondary Outcome Measures:
  • Percentage of Patients With Microbiological Cure at Day 6 [ Time Frame: Day 6 ] [ Designated as safety issue: No ]
    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)

  • Percentage of Patients With Clinical Improvement of Ocular Signs at Day 6 [ Time Frame: Day 6 ] [ Designated as safety issue: No ]
    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.

  • Percentage of Patients With Clinical Improvement of Ocular Symptoms at Day 6 [ Time Frame: Day 6 ] [ Designated as safety issue: No ]
    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


Enrollment: 578
Study Start Date: August 2007
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Gatifloxacin 0.5% Eye Drops
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
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

  Eligibility

Ages Eligible for Study:   1 Year and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00509873

Locations
United States, Louisiana
Gretna, Louisiana, United States
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan
  More Information

No publications provided

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT00509873     History of Changes
Other Study ID Numbers: 198782-004
Study First Received: July 30, 2007
Results First Received: June 15, 2010
Last Updated: October 24, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Conjunctivitis
Conjunctivitis, Bacterial
Conjunctival Diseases
Eye Diseases
Eye Infections, Bacterial
Bacterial Infections
Eye Infections
Infection
Tetrahydrozoline
Gatifloxacin
Fluoroquinolones
Nasal Decongestants
Vasoconstrictor Agents
 Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Respiratory System Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Infective Agents
Anti-Bacterial Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 16, 2013