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Trial record 9 of 603 for:    "keratitis-ichthyosis-deafness syndrome" OR "Keratitis"

Besifloxacin in Bacterial Keratitis

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ClinicalTrials.gov Identifier: NCT02497365
Recruitment Status : Unknown
Verified September 2016 by Jean Deschenes, McGill University Health Center.
Recruitment status was:  Recruiting
First Posted : July 14, 2015
Last Update Posted : September 15, 2016
Sponsor:
Information provided by (Responsible Party):
Jean Deschenes, McGill University Health Center

Brief Summary:
This is a study comparing a new treatment for bacterial keratitis (also known as corneal ulcers) with the current standard of care. It is a randomized trial, and the investigators plan to test whether besifloxacin (a new antibiotic) in comparison to the current standard of treatment, fortified antibiotic drops (cefazolin and tobramycin).

Condition or disease Intervention/treatment Phase
Bacterial Keratitis Drug: Besifloxacin Drug: Tobramycin and Cefazolin Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Besifloxacin Ophthalmic Suspension in Patients With Bacterial Keratitis: A Prospective, Randomized Clinical Study
Study Start Date : September 2015
Estimated Primary Completion Date : January 2017
Estimated Study Completion Date : July 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group A: Besifloxacin
Patients presenting with bacterial keratitis. These patients will be treated with besifloxacin ophthalmic suspesnion 0.6%, initially 6x a day and tapered down as the patient's condition improves based on the clinical judgement of the treating physician.
Drug: Besifloxacin
Active Comparator: Group B: Fortified Antibiotics
Patients presenting with bacterial keratitis. These patients will be treated initially with fortified cefazolin and vancomycin drops every 1 hour around the clock (24hours) for a minimum of 48 hours, and will subsequently have their dosages tapered gradually by the treating physician as is the standard of care for bacterial keratitis.
Drug: Tobramycin and Cefazolin
Fortified Tobramycin and Cefazolin eye drops




Primary Outcome Measures :
  1. Time to microbial sterilization of the infected cornea [ Time Frame: 2-14 days ]
    We will take repeat cultures and determine when no more bacteria can be cultured


Secondary Outcome Measures :
  1. Time until closure of epithelial defect [ Time Frame: 2-14 days ]
  2. Final pinhole corrected visual acuity [ Time Frame: 4 months ]
  3. Final corneal scar size [ Time Frame: 4 months ]
  4. Severe adverse events: corneal perforation, endophthalmitis [ Time Frame: 4 months ]
  5. Time until clinical resolution as determined by physician [ Time Frame: 4 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • • Provide signed and dated informed consent form

    • Willing to comply with all study procedures and be available for the duration of the study
    • Male or female, aged 18 or older
    • Clinically diagnosed bacterial keratitis, with any size ulcer > 1mm.

Exclusion Criteria:

  • • Previously treated for current episode of bacterial keratitis with an antibiotic drop

    • Corneal Ulcers <1mm
    • Known allergic reaction to components of the study products

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02497365


Contacts
Contact: Michael Ross 514-791-3606 michael.ross4@mail.mcgill.ca

Locations
Canada, Quebec
McGill Academic Eye Center Recruiting
Montreal, Quebec, Canada, H4A 3S9
Contact: Michael Ross, MD    51493444074    mrosscan@gmail.com   
Sponsors and Collaborators
McGill University Health Center

Responsible Party: Jean Deschenes, Professor, McGill University Health Center
ClinicalTrials.gov Identifier: NCT02497365     History of Changes
Other Study ID Numbers: OPHTHO101
First Posted: July 14, 2015    Key Record Dates
Last Update Posted: September 15, 2016
Last Verified: September 2016

Keywords provided by Jean Deschenes, McGill University Health Center:
keratits
besifloxacin

Additional relevant MeSH terms:
Keratitis
Corneal Diseases
Eye Diseases
Cefazolin
Tobramycin
Fluoroquinolones
7-(3-aminohexahydro-1H-azepin-1-yl)-8-chloro-1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-3-quinolinecarboxylic acid
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Nucleic Acid Synthesis Inhibitors