Clinical Trial: Besifloxacin in Bacterial Keratitis

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Besifloxacin Ophthalmic Suspension in Patients With Bacterial Keratitis: A Prospective, Randomized Clinical Study

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).

Detailed Summary:

Hypothesis: patients with bacterial keratitis treated with besifloxacin ophthalmic suspension will have non inferior clinical outcomes as compared to those treated with fortified antibiotic drops (tobramycin and cefazolin)

Bacterial keratitis is a serious ocular problem that can, if not appropriately treated, lead to corneal scarring, perforation, endophthalmitis, and ultimately blindness. Current accepted treatment by some practitioners at a major academic center (McGill University Department of Ophthalmology) for corneal ulcers involves aggressive therapy with fortified antibiotics1, typically tobramycin (for gram negative coverage) and either vancomycin or cefazolin (for gram positive and/or MRSA coverage).

However, there are a number of problems with this treatment method. Patients must obtain the fortified antibiotics from specific pharmacies who must compound the preparations, increasing cost to the patient and potentially risk of contamination. The regimen typically involves every hour, round the clock dosing for at least the 48 hours, causing significant distress to patients (many of whom are eldery) and their families, as well as compliance issues. Finally, fortified antibiotics are toxic, by retarding the epithelial healing rate, as well as having conjunctival and corneal toxic effects.

The investigators' overall goal is to determine whether besifloxacin (at less frequent dosing than that used with fortified antibiotics) can be used safely and effectively in the treatment of bacterial keratitis. Previous studies have examined its effect on bacterial conjunctivitis, but not to the investigators' knowledge bacterial keratitis. However, as some clinicians are already using besifloxacin in this purpose, the investigators wish to examine the safety and efficacy of this
Sponsor: McGill University Health Center

Current Primary Outcome: 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


Original Primary Outcome: Same as current

Current Secondary Outcome:

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


Original Secondary Outcome: Same as current

Information By: McGill University Health Center

Dates:
Date Received: July 10, 2015
Date Started: September 2015
Date Completion: July 2017
Last Updated: September 14, 2016
Last Verified: September 2016