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

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

Official Title
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A Study to Evaluate the Clinical and Microbial Efficacy of 0.6% ISV-403 Compared to Vehicle in the Treatment of Bacterial Conjunctivitis.

Conditions
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Acute Bacterial Conjunctivitis

Intervention / Treatment
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* Drug: ISV-403
* Drug: Vehicle


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 1 Year

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ISV-403<br>0.6% ISV-403 ophthalmic suspension | Drug: ISV-403<br>* Subjects with bacterial conjunctivitis were randomized to receive 0.6% ISV-403 eye drops three times a day (TID) for 5 days.<br>* Other names: BOL-303224;|
| Placebo Comparator: Vehicle<br>Vehicle of ISV-403 ophthalmic suspension | Drug: Vehicle<br>* Subjects with bacterial conjunctivitis were randomized to receive vehicle eye drops three times a day (TID) for 5 days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Resolution of Baseline Bacterial Conjunctivitis | The absence (grade 0 on the ordinal scale) of ocular discharge and bulbar conjunctival injection | 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. | Day 5 +/- 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Resolution of Baseline Bacterial Conjunctivitis | The absence (grade 0 on the ordinal scale) of ocular discharge and bulbar conjunctival injection | 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. | Day 8 or 9 |