NCT00651586

Safety and Efficacy Study of Gatifloxacin Compared With Ciprofloxacin in Patients With Acute Bacterial Corneal Ulcers

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 129 (actual)
• Sponsor: Allergan · Industry
• Sex: All
• Age: 8 Years
• Healthy volunteers: Not accepted

Summary

This study evaluates the safety and efficacy of gatifloxacin 0.3% ophthalmic solution compared with ciprofloxacin 0.3% ophthalmic solution in patients with acute bacterial corneal ulcers

Conditions

• Acute Bacterial Corneal Ulcers
• Bacterial Keratitis

Interventions

Type	Name	Description
DRUG	Gatifloxacin 0.3% ophthalmic solution	Gatifloxacin 0.3% ophthalmic solution. On Day 0, one drop instilled in affected eye every 5 minutes for the first 30 minutes, every 30 minutes while awake, and every 2 hours after retiring; on Day 1, one drop instilled in affected eye every hour while awake and 4 hours after retiring; on Days 2 to 6, one drop instilled in affected eye every 2 hours while awake; on Days 7 to 21, one drop instilled in affected eye 4 times daily while awake. Treatment continued through Day 21 (or Day 28 if ulcer had not healed but was improving); dosing terminated when re-epithelialization was complete or on Day 28, whichever occurred sooner
DRUG	Ciprofloxacin 0.3% ophthalmic solution	Ciprofloxacin 0.3% ophthalmic solution. On Day 0, one drop instilled in affected eye every 5 minutes for the first 30 minutes, every 30 minutes while awake, and every 2 hours after retiring; on Day 1, one drop instilled in affected eye every hour while awake and 4 hours after retiring; on Days 2 to 6, one drop instilled in affected eye every 2 hours while awake; on Days 7 to 21, one drop instilled in affected eye 4 times daily while awake. Treatment continued through Day 21 (or Day 28 if ulcer had not healed but was improving); dosing terminated when re-epithelialization was complete or on Day 28, whichever occurred sooner

Timeline

• Start date: 2003-10-01
• Primary completion: 2005-04-01
• Completion: 2005-04-01
• First posted: 2008-04-03
• Last updated: 2008-07-29

Locations

2 sites across 2 countries: United States, India