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| Sponsor: | Allergan |
|---|---|
| Information provided by: | Allergan |
| ClinicalTrials.gov Identifier: | NCT00464438 |
Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
Bacterial Conjunctivitis |
Drug: gatifloxacin Drug: moxifloxacin 0.5% eye drops |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study |
| Enrollment: | 171 |
| Study Start Date: | June 2007 |
| Study Completion Date: | September 2008 |
| Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 1: Experimental |
Drug: gatifloxacin
Day 1-6 = 1 drop of study medication three times a day
|
| 2: Active Comparator |
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
|
Eligibility| Ages Eligible for Study: | up to 31 Days |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| Responsible Party: | Allergan, Inc. ( Therapeutic Area Head ) |
| Study ID Numbers: | 198782-003 |
| Study First Received: | April 19, 2007 |
| Last Updated: | September 22, 2009 |
| ClinicalTrials.gov Identifier: | NCT00464438 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Bacterial Infections Eye Infections, Bacterial Anti-Infective Agents Conjunctivitis, Bacterial Eye Diseases Eye Infections Conjunctivitis |
Infection Conjunctival Diseases Pharmacologic Actions Gatifloxacin Moxifloxacin Therapeutic Uses |