A Phase 2 interventional study of Gatifloxacin 0.3% ophthalmic solution and Ciprofloxacin 0.3% ophthalmic solution in Acute Bacterial Corneal Ulcers and Bacterial Keratitis, sponsored by Allergan. Completed at 2 sites in 2 countries. Open to participants aged 8 Years and older. Per ClinicalTrials.gov, last updated 2008-07-29.
Sponsored by Allergan · Phase 2, Interventional, and Treatment
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
57 studies on the registry are indexed under Corneal Ulcer; 8 are open to participants now.
This study's enrollment of 129 is above the median of 60 across 45 interventional studies indexed under Corneal Ulcer.
Browse Corneal Ulcer studies →Allergan is the lead sponsor of 499 studies on the registry; none are open to participants now.
Of its 91 completed or terminated interventional studies of FDA-regulated products, 89 (98%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Gatifloxacin 0.3% ophthalmic solution
Drug: Gatifloxacin 0.3% ophthalmic solution
Ciprofloxacin 0.3% ophthalmic solution
Drug: Ciprofloxacin 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
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
Also known as: Ciloxan®
Complete re-epithelialization of the corneal ulcer
Time frame: Day 21
Investigator's evaluation of clinical efficacy
Time frame: Day 21
Patient reported outcomes
Time frame: Day 21
Microbiological Cure
Time frame: Day 21
This study is completed, as verified in Jul 2008. You cannot join it, but the record below documents what was studied.
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