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

Bausch & Lomb Incorporated957 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

957

Conditions

Acute Bacterial Conjunctivitis

Interventions

ISV-403DRUG

Subjects with bacterial conjunctivitis were randomized to receive 0.6% ISV-403 eye drops three times a day (TID) for 5 days.

VehicleDRUG

Subjects with bacterial conjunctivitis were randomized to receive vehicle eye drops three times a day (TID) for 5 days.

Eligibility

Sex: ALLMin age: 1 Year

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Clinical Resolution of Baseline Bacterial Conjunctivitis

The absence (grade 0 on the ordinal scale) of ocular discharge and bulbar conjunctival injection

Time frame: Day 5 +/- 1 day

Microbial Eradication of Baseline Bacterial Infection

Absence (grade 0 on the ordinal scale) of all ocular bacterial species that were present at or above the threshold value for that species from the Cagle list at baseline.

Time frame: Day 5 +/- 1 day

Secondary Outcomes

Clinical Resolution of Baseline Bacterial Conjunctivitis

The absence (grade 0 on the ordinal scale) of ocular discharge and bulbar conjunctival injection

Time frame: Day 8 or 9

Microbial Eradication of Baseline Bacterial Infection

Absence (grade 0 on the ordinal scale) of all ocular bacterial species that were present at or above the threshold value for that species from the Cagle list at baseline.

Time frame: Day 8 or 9

Data from ClinicalTrials.gov

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