Efficacy of Besifloxacin Ophthalmic Suspension in the Treatment of Bacterial Conjunctivitis

Bausch + Lomb

Status and phase: Completed; Phase 3; Phase 2

Conditions: Bacterial Conjunctivitis

Treatments: Drug: Vehicle (Placebo); Drug: Besifloxacin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00972777

603

Details and patient eligibility

About

This study is being conducted to evaluate the clinical and microbial efficacy of besifloxacin ophthalmic suspension compared with vehicle in the treatment of bacterial conjunctivitis. This study was conducted as a phase IIb study and continued with further enrollment as a phase III study.

Enrollment: 474 patients

Sex: All

Ages: 1+ year old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects who are at least one year of age.
• Subjects who have a clinical diagnosis of acute bacterial conjunctivitis.
• Subjects who are willing to discontinue contact lens wear for the duration of the study.

Exclusion criteria

• Subjects who have any uncontrolled systemic disease or debilitating disease.
• Subjects with known sensitivity or contraindications to besifloxacin, fluoroquinolones or any ingredients in study drugs.
• Subjects who are expected to require treatment with any disallowed medications.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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474 participants in 2 patient groups, including a placebo group

Besifloxacin

Experimental group

Description:

0.6% ophthalmic suspension

Treatment:

Drug: Besifloxacin

Vehicle

Placebo Comparator group

Treatment:

Drug: Vehicle (Placebo)