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

Primary Purpose

Bacterial Conjunctivitis

Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Besivance
Gatifloxacin
Sponsored by
Bausch & Lomb Incorporated
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bacterial Conjunctivitis focused on measuring Ocular infections, bacterial

Eligibility Criteria

1 Day - 31 Days (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Bausch & Lomb Incorporated

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Besivance

Gatifloxacin

Arm Description

Besifloxacin 0.6% ophthalmic suspension

Gatifloxacin 0.3% ophthalmic solution

Outcomes

Primary Outcome Measures

Clinical Resolution
Clinical resolution defined as the absence of both conjunctival discharge and conjunctival hyperemia.

Secondary Outcome Measures

Clinical Resolution
Clinical resolution defined as the absence of both conjunctival discharge and conjunctival hyperemia.
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
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

Full Information

First Posted
April 5, 2011
Last Updated
September 2, 2014
Sponsor
Bausch & Lomb Incorporated
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1. Study Identification

Unique Protocol Identification Number
NCT01330355
Brief Title
Besifloxacin Ophthalmic Suspension Verses Gatifloxacin Ophthalmic Solution in Neonates With Bacterial Conjunctivitis
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Terminated
Why Stopped
Lack of enrollment
Study Start Date
May 2011 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
October 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bausch & Lomb Incorporated

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bacterial Conjunctivitis
Keywords
Ocular infections, bacterial

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigator
Allocation
Randomized
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Besivance
Arm Type
Experimental
Arm Description
Besifloxacin 0.6% ophthalmic suspension
Arm Title
Gatifloxacin
Arm Type
Active Comparator
Arm Description
Gatifloxacin 0.3% ophthalmic solution
Intervention Type
Drug
Intervention Name(s)
Besivance
Intervention Description
Besifloxacin hydrochloride 0.6% ophthalmic suspension, one drop instilled into infected eye, three times daily (TID) for 7 days
Intervention Type
Drug
Intervention Name(s)
Gatifloxacin
Intervention Description
Gatifloxacin 0.3% ophthalmic solution one drop instilled into infected eye, TID for 7 days
Primary Outcome Measure Information:
Title
Clinical Resolution
Description
Clinical resolution defined as the absence of both conjunctival discharge and conjunctival hyperemia.
Time Frame
Visit 5 (Day 8+1)
Secondary Outcome Measure Information:
Title
Clinical Resolution
Description
Clinical resolution defined as the absence of both conjunctival discharge and conjunctival hyperemia.
Time Frame
Visit 3 (Day 3)
Title
Microbial Eradication
Description
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
Time Frame
Visit 5 (Day 8+1)
Title
Microbial Outcome
Description
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
Time Frame
Visit 3 (Day 3) and Visit 5 (Day 8+1)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
31 Days
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Johnson Varughese
Organizational Affiliation
Valeant/Bausch & Lomb
Official's Role
Study Director
Facility Information:
Facility Name
Bausch & Lomb Incorporated
City
Bridgewater
State/Province
New Jersey
ZIP/Postal Code
08807
Country
United States

12. IPD Sharing Statement

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

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