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

Study Type: Interventional

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

Study Primary Completion Date: June 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: 1
• Placebo Comparator: 2

Primary Measures

• Proportion of patients with clearing of conjunctival hyperemia and conjunctival discharge
  • Time Frame: Day 6
    Safety Issue?: No

Secondary Measures

• Microbiological cure
  • Time Frame: Day 6
    Safety Issue?: No
• Clinical improvement of ocular signs
  • Time Frame: Day 6
    Safety Issue?: No
• Clinical improvement of ocular symptoms
  • Time Frame: Day 6
    Safety Issue?: No

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

Lead Sponsor: Allergan

Overall Clinical Trial Officials and Contacts

Overall Contact: Allergan Inc  clinicaltrials@allergan.com

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00509873

Study ID Number: 198782-004

ClinicalTrials.gov Identifier: NCT00509873

Health Authority: United States: Food and Drug Administration