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

PHASE2CompletedINTERVENTIONAL
Enrollment

129

Participants

Timeline

Start Date

October 31, 2003

Primary Completion Date

April 30, 2005

Study Completion Date

April 30, 2005

Conditions
Acute Bacterial Corneal UlcersBacterial Keratitis
Interventions
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

Trial Locations (2)

Unknown

Galveston

Madurai

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Allergan

INDUSTRY