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

Evaluation of the Safety and Efficacy of Topical Besifloxacin Ophthalmic Suspension, 0.6% Compared With Gatifloxacin, 0.3% Ophthalmic Solution for the Treatment of Presumed Bacterial Conjunctivitis in Subjects From Birth to 31 Days of Age

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).

Study Overview

• Status: Terminated
• Conditions: Bacterial Conjunctivitis
• Intervention / Treatment: Drug: Besivance; Drug: Gatifloxacin

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Bridgewater, New Jersey, United States, 08807
      • Bausch & Lomb Incorporated

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 1 month (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Besivance; Besifloxacin 0.6% ophthalmic suspension	Drug: Besivance; Besifloxacin hydrochloride 0.6% ophthalmic suspension, one drop instilled into infected eye, three times daily (TID) for 7 days
ACTIVE_COMPARATOR: Gatifloxacin; Gatifloxacin 0.3% ophthalmic solution	Drug: Gatifloxacin; Gatifloxacin 0.3% ophthalmic solution one drop instilled into infected eye, TID for 7 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Resolution	Clinical resolution defined as the absence of both conjunctival discharge and conjunctival hyperemia.	Visit 5 (Day 8+1)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Resolution	Clinical resolution defined as the absence of both conjunctival discharge and conjunctival hyperemia.	Visit 3 (Day 3)
Microbial Eradication	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	Visit 5 (Day 8+1)
Microbial Outcome	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	Visit 3 (Day 3) and Visit 5 (Day 8+1)

Collaborators and Investigators

• Sponsor: Bausch & Lomb Incorporated
• Investigators: Study Director: Johnson Varughese, Valeant/Bausch & Lomb

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (ACTUAL): January 1, 2013
• Study Completion (ACTUAL): October 1, 2013

Study Registration Dates

• First Submitted: April 5, 2011
• First Submitted That Met QC Criteria: April 5, 2011
• First Posted (ESTIMATE): April 6, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): September 3, 2014
• Last Update Submitted That Met QC Criteria: September 2, 2014
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Keywords: Ocular infections, bacterial
• Additional Relevant MeSH Terms: Infections; Eye Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Conjunctival Diseases; Eye Infections, Bacterial; Eye Infections; Conjunctivitis; Conjunctivitis, Bacterial; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Anti-Bacterial Agents; Pharmaceutical Solutions; Ophthalmic Solutions; Gatifloxacin; Besifloxacin
• Other Study ID Numbers: 646