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Completed

NCT Number: NCT00651586

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

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

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Key information

Conditions

Acute Bacterial Corneal Ulcers Bacterial Keratitis

Age range

8 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Madurai, Tamil Nadu, India

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Clinical diagnosis in one eye only of an acute bacterial corneal ulcer (>1mm)

Exclusion criteria

  • Corneal ulcer that in the opinion of the investigator had to be treated with fortified antibiotics, or multiple antibiotics, or anti-infectives other than study medication

Treatment and study plan

Gatifloxacin 0.3% ophthalmic solution

Drug

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

Drug

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

Other names: Ciloxan®

Primary outcomes

  1. Complete re-epithelialization of the corneal ulcer

    Time frame: Day 21

Secondary outcomes

  1. Investigator's evaluation of clinical efficacy

    Time frame: Day 21

  2. Patient reported outcomes

    Time frame: Day 21

  3. Microbiological Cure

    Time frame: Day 21

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Registry information

Important dates

Study start
2003
Primary completion
2005
Study completion
2005
First posted
Apr 3, 2008
Registry last updated
Jul 29, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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