None listed
Conditions
Brief summary
To determine the clinical efficacy and safety of moxifloxacin (1.0%) in patients treated with bacterial keratitis compared with patients treated with ofloxacin (0.3%) or fortified tobramycin (1.33%)/cephazolin (5%).
Interventions
To determine clinical efficacy and safety for topical moxifloxacin (1.0%) in patients treated with bacterial keratitis. A comparison will be made to patients treated with topical ofloxacin (0.3%) or topical fortified tobramycin (1.33%)/cephazolin(5%). After corneal specimens are obtained, the assigned study medication is to be instilled every hour day and night for 48 hours and on the third day every hour by day and every two hours at night. For days four and five one drop every two hours by d
To determine clinical efficacy and safety for topical moxifloxacin (1.0%) in patients treated with bacterial keratitis. A comparison will be made to patients treated with topical ofloxacin (0.3%) or topical fortified tobramycin (1.33%)/cephazolin(5%). After corneal specimens are obtained, the assigned study medication is to be instilled every hour day and night for 48 hours and on the third day every hour by day and every two hours at night. For days four and five one drop every two hours by day and every four hours at night and for days six and seven one drop every four hours. After day seven, the antibiotic is to be tapered to six hourly and stopped when when the ulcer has healed.
Sponsors
Centre for Eye Research Australia
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
1 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients at least one year of age, of any race and either sex.•Have a diagnosis of bacterial keratitis based on clinical observation.•Must be able to understand and sign an informed consent form that has been approved by the Human Research and Ethics Committee. If the patient is under 18 years of age, the informed consent must be understood and signed by the patient’s legally authorized representative (parent or guardian).•Must agree to comply with the visit schedule and other requirements of the study. The parent or guardian must agree to ensure compliance of patients less than 18 years of age.•If patients have an infection in both eyes, then only one will be treated with the study medication.
Exclusion criteria
Known allergy to fluoroquinolones, aminoglycosides, penicillins, cephalosporins or benzalkonium chloride.•Pregnant females.•Patients under 1 year of age.•Suspected fungal, viral (e.g. Herpes simplex) or Acanthomoeba infection based on clinical observation.•Patients to be treated with subconjunctival injection(s) of antibiotic(s).
Outcome results
None listed