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

NCT00651586 | Completed Phase 2

• 1 other identifier: 198782-002
• Study Type: interventional
• Target: 129
• Locations: 2 countries
• Sites: 2

Brief 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

Outcome Measures

Primary Outcomes (1)

• Complete re-epithelialization of the corneal ulcer

  Day 21

Secondary Outcomes (3)

• Investigator's evaluation of clinical efficacy

  Day 21

• Patient reported outcomes

  Day 21

• Microbiological Cure

  Day 21

Study Arms (2)

1

EXPERIMENTAL

Gatifloxacin 0.3% ophthalmic solution

Drug: Gatifloxacin 0.3% ophthalmic solution

2

ACTIVE COMPARATOR

Ciprofloxacin 0.3% ophthalmic solution

Drug: Ciprofloxacin 0.3% ophthalmic solution

Interventions

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

1

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

Also known as: Ciloxan®

2

Eligibility Criteria

• Age: 8 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Allergan: lead

Study Sites (2)

Unknown Facility

Galveston, Texas, United States

Location

Unknown Facility

Madurai, Tamil Nadu, India

Location

Related Publications (1)

• Prajna V, Vajpayee R, Trocme S, Davitt WF, III, Jensen H, Liu R, Safyan E. Safety and Efficacy of Gatifloxacin 0.3% as Compared With Ciprofloxacin 0.3% for the Treatment of Acute Bacterial Corneal Ulcers. Investigative Ophthalmology & Visual Science. 5-1-2006; 47(5):1916

  BACKGROUND

Related Links

• Link to Clinical Trial Results

MeSH Terms

Interventions

Gatifloxacin; Ophthalmic Solutions; Ciprofloxacin

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals

Study Officials

• Medical Director

  Allergan

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 1, 2008
• First Posted: April 3, 2008
• Study Start: October 1, 2003
• Primary Completion: April 1, 2005
• Study Completion: April 1, 2005
• Last Updated: July 29, 2008

Record last verified: 2008-07

Locations

IN (1); US (1)