A Study to Investigate the Safety and Efficacy of BOL-303224 in the Treatment of Bacterial Conjunctivitis

Acute Bacterial Conjunctivitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00348348
• Other study ID #: 434
• Status: Completed
• Phase: Phase 3
• First received: June 30, 2006
• Last updated: March 4, 2015
• Start date: June 2006
• Est. completion date: July 2007

Study information

• Verified date: March 2015
• Source: Bausch & Lomb Incorporated
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This is a study to investigate a novel drug candidate for the treatment of bacterial conjunctivitis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1161
• Est. completion date: July 2007
• Est. primary completion date: July 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year and older

Eligibility

Inclusion Criteria:

• Clinical diagnosis of acute bacterial conjunctivitis and exhibit purulent conjunctival discharge and redness in at least one eye.

Exclusion Criteria:

• Pregnant or nursing females.

• Use of any antibiotic within 72 hours of enrollment.

• Any disease conditions that could interfere with the safety and efficacy evaluations of the study drug.

• Participation in an ophthalmic drug or device research study within 30 days prior to entry into this study.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Bacterial Conjunctivitis
• Conjunctivitis
• Conjunctivitis, Bacterial

Intervention

Drug:
• Besifloxacin
Besifloxacin hydrochloride ophthalmic suspension, 0.6% as base, administered TID for 5 days
• Moxifloxacin solution
Moxifloxacin hydrochloride ophthalmic solution 0.5% administered TID for 5 days.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bausch & Lomb Incorporated

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Resolution	Resolution of conjunctival discharge and bulbar conjunctival injection. (mITT, culture confirmed, as treated)	Day 5(+/- 1 day)	No
Primary	Microbial Eradication	eradication of baseline bacterial infection. modified intent to treat (mITT), culture confirmed, as treated	Day 5 (+/- 1 day)	No
Secondary	Clinical Resolution	Clinical resolution of conjunctival discharge and bulbar conjunctival injection, modified intent to treat (mITT), culture confirmed, as treated	Day 8 or Day 9	No
Secondary	Microbial Eradication	Microbial eradication of baseline bacterial infection. modified intent to treat (mITT), culture confirmed, as treated	Day 8 or Day 9	No