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Clinical trial

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

ID
Name
OPHTHO101
Description
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).
Trial arms
Trial start
2015-09-01
Estimated PCD
2019-06-01
Trial end
2019-07-01
Status
Completed
Treatment
Besifloxacin
Arms:
Group A: Besifloxacin
Tobramycin and Cefazolin
Fortified Tobramycin and Cefazolin eye drops
Arms:
Group B: Fortified Antibiotics
Size
32
Primary endpoint
Time to microbial sterilization of the infected cornea
2-14 days
Eligibility 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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 32, 'type': 'ACTUAL'}}
Updated at
2023-10-19

1 organization

2 products

1 indication

Organization
McGill University Health Centre
Product
Besifloxacin
Indication
Bacterial keratitis
Product
Tobramycin + Cefazolin