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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:
NCT00518089
First received: August 16, 2007
Last updated: October 24, 2011
Last verified: October 2011
  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:


Further study details as provided by Allergan:

Primary Outcome Measures:
  • Percentage of Patients With Clearing (Clinical Success) of Conjunctival Hyperemia and Conjunctival Discharge Up to Day 6 [ Time Frame: 6 Days ] [ 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 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).


Secondary 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).

  • Percentage of Patients With Microbiological Cure Up to Day 6 [ Time Frame: 6 Days ] [ 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 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).

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

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


Enrollment: 859
Study Start Date: February 2008
Study Completion Date: January 2009
Primary Completion Date: January 2009 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00518089

Locations
United States, California
Downey, California, United States
India
Rajajinagar, Bangalore, India
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan
  More Information

No publications provided

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT00518089     History of Changes
Other Study ID Numbers: 198782-005
Study First Received: August 16, 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
Bacterial Infections
Conjunctival Diseases
Eye Diseases
Eye Infections
Eye Infections, Bacterial
Infection
Gatifloxacin
Ophthalmic Solutions
Tetrahydrozoline
Anti-Bacterial Agents
Anti-Infective Agents
Antineoplastic Agents
Autonomic Agents
Cardiovascular Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Nasal Decongestants
Peripheral Nervous System Agents
Pharmaceutical Solutions
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Sympathomimetics
Therapeutic Uses
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Vasoconstrictor Agents

ClinicalTrials.gov processed this record on November 20, 2014