A Study to Evaluate the Clinical and Microbial Efficacy of Besifloxacin Ophthalmic Suspension, 0.6% BID Compared to Vehicle in the Treatment of Bacterial Conjunctivitis

NCT01740388 Phase 3 TERMINATED Results posted

To evaluate the clinical and microbial efficacy of besifloxacin ophthalmic suspension, 0.6% (Besifloxacin) administered BID for 3 days compared to vehicle in the treatment of bacterial conjunctivitis.

Details

Lead sponsor	Bausch & Lomb Incorporated
Phase	Phase 3
Status	TERMINATED
Enrolment	136
Start date	2013-02
Completion	2013-11

Conditions

• Bacterial Conjunctivitis

Interventions

• Besifloxacin
• Vehicle

Primary outcomes

• Clinical Resolution — Visit 2 (Day 4 or 5)
  Absence of both conjunctival discharge and bulbar conjunctival injection, after 3 days of treatment with besifloxacin ophthalmic suspension 0.6%
• Microbial Eradication — Visit 2 (Day 4 or 5)
  Absence of all accepted ocular bacterial species that were present at or above threshold at baseline, after 3 days of treatment with besifloxacin ophthalmic suspension 0.6%

Countries

United States