A Study of the Safety and Efficacy of Gatifloxacin in Patients With Bacterial Conjunctivitis

NCT00518089 Phase 3 COMPLETED Results posted

The study will determine the safety and efficacy of gatifloxacin eye drops in patients with bacterial conjunctivitis

Details

Lead sponsor	Allergan
Phase	Phase 3
Status	COMPLETED
Enrolment	859
Start date	2008-02
Completion	2009-01

Conditions

• Bacterial Conjunctivitis

Interventions

• Gatifloxacin 0.5% eye drops
• placebo eye drops

Primary outcomes

• Percentage of Patients With Clearing (Clinical Success) of Conjunctival Hyperemia and Conjunctival Discharge Up to Day 6 — 6 Days
  Percentage of patients that achieved clinical success, defined as achievement of a score of zero for both conjunctival hyperemia and conjunctival discharge in the study eye up to Day 6. Conjunctival hyperemia and conjunctival discharge were each assessed on a 4-point severity grade scale (0=none, +1=mild, +2=moderate, +3=severe).

Countries

United States, India