Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000406505
Ethics application status
Approved
Date submitted
13/09/2006
Date registered
18/09/2006
Date last updated
18/09/2006
Type of registration
Retrospectively registered

Titles & IDs
Public title
Clinical efficacy of Moxifloxacin in the treatment of Bacterial Keratitis: A Randomised Clinical Trial
Scientific title
Clinical efficacy of Moxifloxacin in the treatment of Bacterial Keratitis: A Randomised Clinical Trial
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bacterial Keratitis 1373 0
Condition category
Condition code
Eye 1466 1466 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 1357 0
Treatment: Drugs
Comparator / control treatment
Control group
Active

Outcomes
Primary outcome [1] 2028 0
To assess efficacy and safety of 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%).

A patient is to be evaluated for efficacy if they have completed the study as planned (i.e., treated for the length of time necessary for the ulcer to heal) or if they are considered a treatment failure. A patient is defined as a treatment failure if their corneal ulcer does not respond, necessitating a change in therapy. Patient data is also eligible for analysis of efficacy if the study eye had a culture positive for bacterial organisms at the initial visit. Fungal, viral and acanthamoeba infections are not to be evaluated for efficacy. These cases are to be evaluated for safety only.
Timepoint [1] 2028 0
Examination finding are recorded on days 2, 4, 7, 14, and >16. A final follow-up examination is scheduled for between 2 and 3 months after commencement of treatment.
Secondary outcome [1] 3510 0
The secondary efficacy variables include the number of days of therapy required and required healing time until the ulcer is cured. Cured is defined as no evidence of active bacterial infection, wound healing (re-epithelialisation) complete, i.e. absence of macropunctate staining, and inflammation resolved.
Timepoint [1] 3510 0
A clinical sign score summarizing the keys signs from the biomicroscopic examination on days 2, 4, 7, 14, and >1 will be used as a secondary measure of efficacy. The sign score is the sum of the severity grading (0, 1, 2 or 3) of the following features: erythema swelling, conjunctival discharge, bulbar conjunctival injection, superficial punctuate keratopathy, intensity of infiltration, maximal depth of stromal loss and anterior chamber reaction (cells and flare).

Eligibility
Key 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.
Minimum age
1 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Bottle(s) of the assigned drug(s) will be issued by patient number according to a simple randomisation by using a computer generated randomised code.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Subjects will be blinded within this study
Phase
Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
9/10/2002
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
229
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1603 0
Commercial sector/Industry
Name [1] 1603 0
Alcon Australia
Country [1] 1603 0
Australia
Primary sponsor type
Other
Name
Centre for Eye Research Australia
Address
Country
Australia
Secondary sponsor category [1] 1408 0
Other
Name [1] 1408 0
Centre for Eye Research Australia
Address [1] 1408 0
Country [1] 1408 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3050 0
The Human Research Ethics Committee of the Royal Victorian Eye and Ear Hospital
Ethics committee address [1] 3050 0
Ethics committee country [1] 3050 0
Australia
Date submitted for ethics approval [1] 3050 0
Approval date [1] 3050 0
Ethics approval number [1] 3050 0
02/473H

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27964 0
Address 27964 0
Country 27964 0
Phone 27964 0
Fax 27964 0
Email 27964 0
Contact person for public queries
Name 10546 0
Marios Constantinou
Address 10546 0
32 Gisborne St East Melbourne VIC
Country 10546 0
Australia
Phone 10546 0
03 9929 8434
Fax 10546 0
Email 10546 0
[email protected]
Contact person for scientific queries
Name 1474 0
Dr Grant Snibson
Address 1474 0
32 Gisborne St East Melbourne, VIC
Country 1474 0
Australia
Phone 1474 0
03 9929 8434
Fax 1474 0
Email 1474 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.