A Study to Determine if 0.6% ISV-403 is Safe and Effective in the Treatment of Bacterial Conjunctivitis.

Bausch + Lomb

Status and phase: Completed; Phase 3

Conditions: Acute Bacterial Conjunctivitis

Treatments: Drug: Vehicle; Drug: ISV-403

Study type: Interventional

Funder types: Industry

Identifiers

NCT00347932

BOL-303224 (Registry Identifier)

433

Details and patient eligibility

About

Evaluation of the clinical and microbial efficacy of 0.6% ISV-403, compared to vehicle in the treatment of bacterial conjunctivitis.

Enrollment: 957 patients

Sex: All

Ages: 1+ year old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Must have a diagnosis of acute bacterial conjunctivitis and exhibit purulent conjunctival discharge and redness in at least one eye.
• Females of childbearing potential must utilized reliable contraceptive methods and have a negative pregnancy test.

Exclusion criteria

• Pregnant or nursing females.
• Known hypersensitivity to fluoroquinolones or to any of the study ingredients.
• Use of any antibiotic within 72 hours of treatment.
• Any disease or condition that could interfere with the safety and efficacy evaluations of the study medications.
• Participation in an ophthalmic drug or device research study within 30 days prior to entry into the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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957 participants in 2 patient groups, including a placebo group

ISV-403

Experimental group

Description:

0.6% ISV-403 ophthalmic suspension

Treatment:

Drug: ISV-403

Vehicle

Placebo Comparator group

Description:

Vehicle of ISV-403 ophthalmic suspension

Treatment:

Drug: Vehicle