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

Verified by: Allergan, October 2011
First Received: August 16, 2007 | Last Updated: October 24, 2011 | Phase: Phase 3 | Start Date: February 2008
Overall Status: Completed | Estimated Enrollment: 859
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The study will determine the safety and efficacy of gatifloxacin eye drops in patients with bacterial...

Brief Summary

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

  • 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
  • Study Primary Completion Date: January 2009

Intervention(s) in this Clinical Trial

  • 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
  • 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

Arms, Groups and Cohorts in this Clinical Trial

  • Experimental: Gatifloxacin 0.5% Eye Drops
    • Gatifloxacin 0.5% Eye Drops
  • Placebo Comparator: Placebo Eye Drops
    • Placebo Eye Drops

Outcome Measures for this Clinical Trial

Primary Measures

  • Percentage of Patients With Clearing (Clinical Success) of Conjunctival Hyperemia and Conjunctival Discharge Up to Day 6
    • Time Frame: 6 Days
      Safety Issue?: No

Secondary Measures

  • Percentage of Patients With Clearing (Clinical Success) of Conjunctival Hyperemia and Conjunctival Discharge at Day 6
    • Time Frame: Day 6
      Safety Issue?: No
  • Percentage of Patients With Microbiological Cure Up to Day 6
    • Time Frame: 6 Days
      Safety Issue?: No
  • Percentage of Patients With Clinical Improvement of Ocular Signs Up to Day 6
    • Time Frame: 6 Days
      Safety Issue?: No
  • Percentage of Patients With Clinical Improvement of Ocular Symptoms Up to Day 6
    • Time Frame: 6 Days
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 1 Year

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Clinical Trial Investigator Information

Lead Investigator: Allergan Industry

Overall Clinical Trial Officials and Contacts

Medical Director Study Director Allergan  

Additional Information

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00518089

Study ID Number: 198782-005

ClinicalTrials.gov Identifier: NCT00518089

Health Authority: United States: Food and Drug Administration

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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00518089