Besifloxacin Ophthalmic Suspension Verses Gatifloxacin Ophthalmic Solution in Neonates With Bacterial Conjunctivitis

Phase 3

Terminated

• Conditions: Bacterial Conjunctivitis
• Interventions: Drug: Besivance; Drug: Gatifloxacin

• Registration Number: NCT01330355
• Lead Sponsor: Bausch & Lomb Incorporated

Brief Summary

The objective of this study is to evaluate the safety and efficacy of Besivance (besifloxacin 0.6%) ophthalmic suspension compared to gatifloxacin 0.3% ophthalmic solution when administered three times daily (TID) for seven days to neonatal subjects who are 31 days or younger on the day of randomization (Visit 1).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-04-05
• Study First Submitted QC: 2011-04-05
• Study First Posted: 2011-04-06
• Study Start: 2011-05
• Primary Completion: 2013-01
• Study Completion: 2013-10
• Status Verified: 2014-08
• Results First Submitted: 2014-08-21
• Results First Submitted QC: 2014-09-02
• Last Update Submitted: 2014-09-02
• Results First Posted: 2014-09-03
• Last Update Posted: 2014-09-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 33

Inclusion Criteria

• Subjects who have a clinical diagnosis of acute bacterial conjunctivitis and exhibit conjunctival discharge and redness in at least one eye. A minimum score of 1 should be present for discharge and a minimum score of 1 for conjunctival hyperemia in the same eye.

Exclusion Criteria

• Subjects with conjunctivitis signs and/or symptoms suggestive of fungal, protozoal, or viral etiology in either eye.
• Subjects who require or are expected to require (other than study medication) use of any topical ocular medication in either eye, or systemic medications during the course of the study or prior to Day 1 specified in the protocol as ineligible.
• Subjects with any abnormality of the ocular anatomy or ocular disease/disorder specified in the protocol as ineligible.
• Subjects with systemic disease/disorder specified in the protocol as ineligible.
• Subjects who have a known or suspected poor tolerance, sensitivity, or allergy to the study medications or any of their components.
• Subjects who have a condition or are in a situation which in the investigator's opinion may impact their safety or would negatively affect the conduct or outcome of the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Besivance	Besivance	Besifloxacin 0.6% ophthalmic suspension
Gatifloxacin	Gatifloxacin	Gatifloxacin 0.3% ophthalmic solution

Primary Outcome Measures

Name	Time	Method
Clinical Resolution	Visit 5 (Day 8+1)	Clinical resolution defined as the absence of both conjunctival discharge and conjunctival hyperemia.

Secondary Outcome Measures

Name	Time	Method
Clinical Resolution	Visit 3 (Day 3)	Clinical resolution defined as the absence of both conjunctival discharge and conjunctival hyperemia.
Microbial Eradication	Visit 5 (Day 8+1)	Eradication defined as the absence of all accepted ocular bacterial species (as measured on the ordinal scale) that were present at or above threshold at baseline
Microbial Outcome	Visit 3 (Day 3) and Visit 5 (Day 8+1)	Microbial outcome for the following groups of accepted ocular bacterial species that were present at or above threshold at baseline: * over all bacterial species; * over all and individual gram-positive bacterial species; * over all and individual gram-negative bacterial species

Trial Locations

Locations (1)

Bausch & Lomb Incorporated; 🇺🇸 Bridgewater, New Jersey, United States