A Study to Investigate the Safety and Efficacy of BOL-303224 in the Treatment of Bacterial Conjunctivitis

Bausch + Lomb

Status and phase: Completed; Phase 3

Conditions: Acute Bacterial Conjunctivitis

Treatments: Drug: Moxifloxacin solution; Drug: Besifloxacin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00348348

434

Details and patient eligibility

About

This is a study to investigate a novel drug candidate for the treatment of bacterial conjunctivitis.

Enrollment: 1,161 patients

Sex: All

Ages: 1+ year old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinical diagnosis of acute bacterial conjunctivitis and exhibit purulent conjunctival discharge and redness in at least one eye.

Exclusion criteria

• Pregnant or nursing females.
• Use of any antibiotic within 72 hours of enrollment.
• Any disease conditions that could interfere with the safety and efficacy evaluations of the study drug.
• Participation in an ophthalmic drug or device research study within 30 days prior to entry into this study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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1,161 participants in 2 patient groups

Moxifloxacin solution

Active Comparator group

Description:

Moxifloxacin hydrochloride ophthalmic solution 0.5%

Treatment:

Drug: Moxifloxacin solution

Besifloxacin Suspension

Experimental group

Description:

Besifloxacin hydrochloride ophthalmic suspension 0.6%

Treatment:

Drug: Besifloxacin