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

Allergan

Status and phase: Completed; Phase 2

Conditions: Bacterial Keratitis; Acute Bacterial Corneal Ulcers

Treatments: Drug: Ciprofloxacin 0.3% ophthalmic solution; Drug: Gatifloxacin 0.3% ophthalmic solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT00651586

198782-002

Details and patient eligibility

About

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

Enrollment: 129 patients

Sex: All

Ages: 8+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

129 participants in 2 patient groups

1

Experimental group

Description:

Gatifloxacin 0.3% ophthalmic solution

Treatment:

Drug: Gatifloxacin 0.3% ophthalmic solution

2

Active Comparator group

Description:

Ciprofloxacin 0.3% ophthalmic solution

Treatment:

Drug: Ciprofloxacin 0.3% ophthalmic solution