Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02497365 |
| Other study ID # |
OPHTHO101 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
September 2015 |
| Est. completion date |
July 2019 |
Study information
| Verified date |
October 2023 |
| Source |
McGill University Health Centre/Research Institute of the McGill University Health Centre |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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).
Description:
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.
If the investigators' study shows that besifloxacin is safe and effective in the treatment of
bacterial keratitis, a new treatment option for bacterial keratitis may emerge.
The investigators therefore plan to conduct a randomized, open label trial enrolling patients
newly diagnosed and not previously treated with bacterial keratitis. The patients will be
randomized to receive either besifloxacin 6 x daily initially, or fortified antibiotics
(cefazolin and tobramycin) every hour. The investigators will follow the patients closely to
try to evaluate whether besifloxacin is an effective treatment for bacterial keratitis.
This is a randomized, single-center, two-arm, open-label study comparing a novel therapy,
besofloxacin ophthalmic suspension, to traditional therapy of fortified cefazolin and
tobramycin drops, in the treatment of bacterial keratitis.
Patients presenting with bacterial keratitis to the McGill Ophthalmology Center at 5252
Maissoneuve in Montreal, will be offered the opportunity by the resident and staff physician
on call, to enroll in the study, with full discussion of risks and benefits as detailed
above. Referrals will come from outpatient clinics and emergency departments as detailed
above. The population of patients is expected to be outpatients, with a wide range of age
groups >18 years old (no pediatrics as the study center does not see any pediatric age
patients).
If patients choose not to enroll in the study, they will proceed to receive standard
treatment at the center.
If patients choose to enroll in the study, the resident or staff on call, will, in
consultation with the study investigators (Dr Jean Deschenes), use a pre-determined random
number generator to randomize the patients to A) Besifloxacin arm, or B) Fortified
Antibiotics arm.
At the first visit, a complete anterior ophthalmological exam will be performed, along with a
detailed ophthalmic and medical history. Corneal scrapings will be performed (blood agar,
chocolate agar, Sabaroud agar, slide mount for gram stain).
The participant will then be prescribed either Besifloxacin or Fortified Antibiotics
(Cefazolin and Tobramycin) depending on their randomization. The participants will need to
take the prescription to an outside pharmacy for purchase at their own cost of the
medications. Suggested pharmacies will be made for the Fortified Antibiotics arm (as is
standard of care due to the limited number of pharmacies that prepare the compounded drops).
Participants will be re-evaluated multiple times following initial presentation.
In each arm the medication will be tapered according to the clinical discretion of the
treating physicians. In the besifloxacin arm, only besifloxacin will be used. In the
fortified antibiotics arm, the fortified drops will be tapered and may be switched to another
standard of care medication (moxifloxacin drops) as the bacterial keratitis improves as per
the typical treatment regimen. Importantly, in this arm, the treatment will be carried out as
normal standard of care for bacterial keratitis.
In the besifloxacin arm, if, at the visit on day 8, previous corneal bacterial cultures
remain positive, the patient will be crossed over into the fortified antibiotic arm.
Otherwise, crossover may occur only if there is significant clinical deterioration by the
treating physician that requires urgent intervention.
The expected duration of each subject participation is 4 months. Study enrollment is expected
to last for about 4 months as well.
