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A Study of the Safety and Efficacy of Gatifloxacin in Patients With Bacterial Conjunctivitis
This study has been completed.
First Received: July 30, 2007   Last Updated: December 17, 2008   History of Changes
Sponsored by: Allergan
Information provided by: Allergan
ClinicalTrials.gov Identifier: NCT00509873
  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 III

Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study

Resource links provided by NLM:


Further study details as provided by Allergan:

Primary Outcome Measures:
  • Proportion of patients with clearing of conjunctival hyperemia and conjunctival discharge [ Time Frame: Day 6 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Microbiological cure [ Time Frame: Day 6 ] [ Designated as safety issue: No ]
  • Clinical improvement of ocular signs [ Time Frame: Day 6 ] [ Designated as safety issue: No ]
  • Clinical improvement of ocular symptoms [ Time Frame: Day 6 ] [ Designated as safety issue: No ]

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
1: Experimental 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
2: Placebo Comparator 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

Additional Information:
No publications provided

Responsible Party: Allergan, Inc. ( Therapeutic Area Head )
Study ID Numbers: 198782-004
Study First Received: July 30, 2007
Last Updated: December 17, 2008
ClinicalTrials.gov Identifier: NCT00509873     History of Changes
Health Authority: United States: Food and Drug Administration

Study placed in the following topic categories:
Bacterial Infections
Pseudoephedrine
Eye Infections, Bacterial
Conjunctivitis, Bacterial
Eye Diseases
Eye Infections
Cardiovascular Agents
Conjunctivitis
Tetrahydrozoline
Conjunctival Diseases
Nasal Decongestants
Gatifloxacin
Oxymetazoline
Phenylephrine
Vasoconstrictor Agents
Ephedrine
Peripheral Nervous System Agents

Additional relevant MeSH terms:
Bacterial Infections
Anti-Infective Agents
Respiratory System Agents
Eye Infections, Bacterial
Conjunctivitis, Bacterial
Sympathomimetics
Eye Diseases
Physiological Effects of Drugs
Eye Infections
Cardiovascular Agents
Conjunctivitis
Tetrahydrozoline
Infection
Pharmacologic Actions
Conjunctival Diseases
Nasal Decongestants
Gatifloxacin
Autonomic Agents
Therapeutic Uses
Vasoconstrictor Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on July 02, 2009