A Study to Evaluate the Safety and Efficacy of Gatifloxacin for the Treatment of Bacterial Conjunctivitis

Verified by: Allergan, August 2011
First Received: April 19, 2007 | Last Updated: August 17, 2011 | Phase: Phase 4 | Start Date: June 2007
Overall Status: Completed | Estimated Enrollment: 171
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This is a 7 day study to evaluate the safety and efficacy of topical gatifloxacin ophthalmic solution for the treatment of bacterial conjunctivitis in subjects from birth to 31 days of...

Brief Summary

This is a 7 day study to evaluate the safety and efficacy of topical gatifloxacin ophthalmic solution for the treatment of bacterial conjunctivitis in subjects from birth to 31 days of age

  • 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: September 2008

Intervention(s) in this Clinical Trial

  • Drug: gatifloxacin
    • Day 1-6 = 1 drop of study medication three times a day
  • Drug: moxifloxacin 0.5% eye drops
    • Day 1-6 = 1 drop of study medication three times a day

Arms, Groups and Cohorts in this Clinical Trial

  • Experimental: 1
  • Active Comparator: 2

Outcome Measures for this Clinical Trial

Primary Measures

  • Percentage of Patients With Clearing (Clinical Success) of Conjunctival Erythema and Conjunctival Discharge at Day 7
    • Time Frame: Day 7
      Safety Issue?: No

Secondary Measures

  • Percentage of Patients With Microbiological Improvement
    • Time Frame: Day 7
      Safety Issue?: No
  • Percentage of Patients With Improvement in Ocular Signs for Lid Erythema
    • Time Frame: Days 7
      Safety Issue?: No
  • Percentage of Patients With Improvement in Ocular Signs for Conjunctival Discharge at Day 7
    • Time Frame: Day 7
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

Inclusion Criteria:

  • diagnosed with bacterial conjunctivitis

Exclusion Criteria:

  • chemical or foreign body trauma to either eye
  • infection in either eye (besides bacterial conjunctivitis)
  • white spots in the cornea or ulcers in either eye
  • clinical diagnosis of chlamydia or gonorrhea in either eye

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: N/A

Maximum Age for this Clinical Trial: 31 Days

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 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00464438

Study ID Number: 198782-003

ClinicalTrials.gov Identifier: NCT00464438

Health Authority: United States: Food and Drug Administration

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http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00464438