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

This study has been terminated.
(Lack of enrollment)
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT01330355
First received: April 5, 2011
Last updated: April 5, 2013
Last verified: April 2013
History of Changes
  Purpose

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).


Condition Intervention Phase
Bacterial Conjunctivitis
 Drug: Besivance
Drug: Gatifloxacin
 Phase 3

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Bausch & Lomb Incorporated:

Primary Outcome Measures:
  • Clinical Resolution [ Time Frame: Visit 5 (Day 8+1) ] [ Designated as safety issue: No ]
    Clinical resolution defined as the absence of both conjunctival discharge and conjunctival hyperemia.


Secondary Outcome Measures:
  • Clinical Resolution [ Time Frame: Visit 3 (Day 3) ] [ Designated as safety issue: No ]
    Clinical resolution defined as the absence of both conjunctival discharge and conjunctival hyperemia.

  • Microbial Eradication [ Time Frame: Visit 5 (Day 8+1) ] [ Designated as safety issue: No ]
    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

  • Signs of Bacterial Conjunctivitis [ Time Frame: At each visit for 7 days ] [ Designated as safety issue: No ]
    Ocular discharge rated on a scale from 0(none), 1(mild), 2(moderate) to 3(severe) Conjunctiva hyperemia rated on a scale from 0(normal), 1(mild), 2(moderate) to 3(severe)

  • Microbial Outcome [ Time Frame: Visit 3 (Day 3) and Visit 5 (Day 8+1) ] [ Designated as safety issue: No ]

    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


Estimated Enrollment: 200
Study Start Date: May 2011
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   up to 31 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01330355

Locations
United States, New York
Bausch & Lomb Incorporated
Rochester, New York, United States, 14609
Sponsors and Collaborators
Bausch & Lomb Incorporated
Investigators
Study Director: Angele Singh, MD Bausch & Lomb Incorporated
  More Information

No publications provided

Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT01330355     History of Changes
Other Study ID Numbers: 646
Study First Received: April 5, 2011
Last Updated: April 5, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Bausch & Lomb Incorporated:
Ocular infections, bacterial

Additional relevant MeSH terms:
Conjunctivitis
Conjunctivitis, Bacterial
Conjunctival Diseases
Eye Diseases
Eye Infections, Bacterial
Bacterial Infections
Eye Infections
Infection
Gatifloxacin
 Fluoroquinolones
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Bacterial Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 19, 2013