Clinical Trial: Besifloxacin Ophthalmic Suspension Verses Gatifloxacin Ophthalmic Solution in Neonates With Bacterial Conjunctivitis

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

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

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 Summary:
Sponsor: Bausch & Lomb Incorporated

Current Primary Outcome: Clinical Resolution [ Time Frame: Visit 5 (Day 8+1) ]

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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Clinical Resolution [ Time Frame: Visit 3 (Day 3) ]
    Clinical resolution defined as the absence of both conjunctival discharge and conjunctival hyperemia.
  • Microbial Eradication [ Time Frame: 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 [ Time Frame: 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


Original Secondary Outcome:

  • Clinical Resolution [ Time Frame: Visit 3 (Day 3) ]
    Clinical resolution defined as the absence of both conjunctival discharge and conjunctival hyperemia.
  • Microbial Eradication [ Time Frame: 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
  • Signs of Bacterial Conjunctivitis [ Time Frame: At each visit for 7 days ]
    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) ]

    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


Information By: Bausch & Lomb Incorporated

Dates:
Date Received: April 5, 2011
Date Started: May 2011
Date Completion:
Last Updated: September 2, 2014
Last Verified: August 2014