Status:
COMPLETED
A Study to Determine if 0.6% ISV-403 is Safe and Effective in the Treatment of Bacterial Conjunctivitis.
Lead Sponsor:
Bausch & Lomb Incorporated
Conditions:
Acute Bacterial Conjunctivitis
Eligibility:
All Genders
1+ years
Phase:
PHASE3
Brief Summary
Evaluation of the clinical and microbial efficacy of 0.6% ISV-403, compared to vehicle in the treatment of bacterial conjunctivitis.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2007
Estimated Enrollment :
957 Patients enrolled
Trial Details
Trial ID
NCT00347932
Start Date
June 1 2006
End Date
November 1 2007
Last Update
March 24 2015
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