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

Study Primary Completion Date: June 2009

Intervention(s) in this Clinical Trial

• Drug: gatifloxacin 0.3% eye drops
  • 1 drop 3 times per day through Day 6
• Drug: moxifloxacin 0.5% eye drops
  • 1 drop 3 times per day through Day 6

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
• Active Comparator: 2

Primary Measures

• Proportion of patients with clearing of conjunctival erythema and conjunctival discharge
  • Time Frame: Day 7
    Safety Issue?: No

Secondary Measures

• Microbiological improvement
  • Time Frame: Day 7
    Safety Issue?: No
• Improvement in ocular signs
  • Time Frame: Days 1- 7
    Safety Issue?: No
• Improvement in ocular symptoms
  • Time Frame: Days 1- 7
    Safety Issue?: No

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

Lead Sponsor: Allergan

Overall Clinical Trial Officials and Contacts

Overall Contact: Allergan Inc  clinicaltrials@allergan.com

Information obtained from ClinicalTrials.gov on August 29, 2008

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