Besifloxacin in Bacterial Keratitis

NCT02497365 | Completed

• 1 other identifier: OPHTHO101
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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).

Conditions

Bacterial Keratitis

Keywords

keratits; besifloxacin

Outcome Measures

Primary Outcomes (1)

• Time to microbial sterilization of the infected cornea

  We will take repeat cultures and determine when no more bacteria can be cultured

  2-14 days

Secondary Outcomes (5)

• Time until closure of epithelial defect

  2-14 days

• Final pinhole corrected visual acuity

  4 months

• Final corneal scar size

  4 months

• Severe adverse events: corneal perforation, endophthalmitis

  4 months

• Time until clinical resolution as determined by physician

  4 months

Study Arms (2)

Group A: Besifloxacin

EXPERIMENTAL

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

Group B: Fortified Antibiotics

ACTIVE COMPARATOR

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

Interventions

Besifloxacin DRUG

Group A: Besifloxacin

Tobramycin and Cefazolin DRUG

Fortified Tobramycin and Cefazolin eye drops

Group B: Fortified Antibiotics

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Previously treated for current episode of bacterial keratitis with an antibiotic drop
• Corneal Ulcers \<1mm
• Known allergic reaction to components of the study products

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead

Study Sites (1)

McGill Academic Eye Center

Montreal, Quebec, H4A 3S9, Canada

Location

MeSH Terms

Interventions

besifloxacin; Tobramycin; Cefazolin

Intervention Hierarchy (Ancestors)

Nebramycin; Kanamycin; Aminoglycosides; Glycosides; Carbohydrates; Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 10, 2015
• First Posted: July 14, 2015
• Study Start: September 1, 2015
• Primary Completion: June 1, 2019
• Study Completion: July 1, 2019
• Last Updated: October 19, 2023

Record last verified: 2023-10

Locations

CA (1)