Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000823279
Ethics application status
Not yet submitted
Date submitted
15/09/2009
Date registered
21/09/2009
Date last updated
21/09/2009
Type of registration
Prospectively registered

Titles & IDs
Public title
Chloramphenicol In Corneal Abrasions Study
Scientific title
The effects of lubricants versus chloramphenicol on corneal healing in patients with corneal abrasions
Universal Trial Number (UTN)
Trial acronym
CICAS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
corneal abrasions 243492 0
Condition category
Condition code
Eye 239793 239793 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Lubricating Ointment (Polyvisc ointment) applied directly to the eye. Dose is 2cm of ointment, 4 times a day for 2 days.
Intervention code [1] 237112 0
Treatment: Other
Comparator / control treatment
chloramphenicol ointment, which is an antibacterial ointment with lubricant. Dose is 2cm of ointment, 4 times a day for 2 days.
Control group
Active

Outcomes
Primary outcome [1] 240563 0
corneal infection. This will be assessed by a qualified examiner via a slit lamp. Signs of infection include the presence of a corneal ulcer, haziness of the cornea and presence of cells in the anterior chamber.
Timepoint [1] 240563 0
48 hours post discharge from the emergency department after initial presentation.
Primary outcome [2] 240564 0
corneal re-epithelialization assessed by a qualified examiner via a slit lamp looking for signs of persistent corneal abrasions/ulcers, delayed healing.
Timepoint [2] 240564 0
48 hours post discharge from the emergency department after initial presentation.
Secondary outcome [1] 257164 0
side effects of treatment (including local irritation, red eye, swelling of eye lids) assessed by a qualified examiner via a slit lamp.
Timepoint [1] 257164 0
48 hours post discharge from the emergency department after initial presentation.

Eligibility
Key inclusion criteria
corneal abrasion within last 24 hours
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
existence of corneal infection

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)
All patients with simple corneal abrasions presenting to Westmead Hospital who meet our inclusion criteria will be invited to participate. After informed consent is obtained, patients will be randomised into a control group (chloramphenicol ointment) and a treatment group (lubricant). The preparation will occur in the pharmacy (un-blinded) where ointment tubes will be stripped of identifying features and placed in envelopes. In the Emergency Department, a randomisation matrix will be used to randomise subjects to preserve a double-blinded protocol. 48 hours after treatment, patients will be followed up by specialists trained by the Department of Ophthalmology to detect signs of corneal healing and/or corneal infection
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/11/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 243743 0
Self funded/Unfunded
Name [1] 243743 0
Country [1] 243743 0
Australia
Primary sponsor type
Hospital
Name
Westmead Hospital
Address
Hawkesbury Road
Westmead, NSW, 2145
Country
Australia
Secondary sponsor category [1] 237102 0
None
Name [1] 237102 0
Address [1] 237102 0
Country [1] 237102 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 243868 0
Westmead Campus Human Research Ethics Committee (HREC)
Ethics committee address [1] 243868 0
Westmead Hospital,
Westmead, NSW, 2145
Ethics committee country [1] 243868 0
Australia
Date submitted for ethics approval [1] 243868 0
15/09/2009
Approval date [1] 243868 0
Ethics approval number [1] 243868 0

Summary
Brief summary
Chloramphenicol is the commonest ophthalmic antibiotic ointment used by non-ophthalmologists in current practice. It is prescribed by general practitioners and emergency physicians in all cases of corneal abrasions, regardless of severity or mechanism of injury. However, there has been no evidence to determine whether chloramphenicol is the optimum therapeutic agent to treat corneal abrasions. It is uncertain whether the therapeutic effect of chloramphenicol is the antimicrobial agent (decreasing microbial infiltration) or the lubricating ointment (preventing micro-abrasions and speeding corneal re-epithelialization). Further, given the widespread use of chloramphenicol as a first line therapy for uninfected injuries, a serious risk and a major concern is the development of chloramphenicol resistant bacterial species. Thus the purpose of this study is to explore whether a simple lubricating ointment is a viable alternative to chloramphenicol ointment in the treatment of corneal abrasions. If proven correct, this study could potentially revolutionize the treatment of corneal abrasions, significantly decreasing the risk of antibiotic resistant bacteria while providing a cheaper alternative for both patient and hospital.

We aim to conduct a double-blinded randomized control trial comparing chloramphenicol to a lubricating ointment with no antimicrobial properties. Both ointments will be prepared within the Pharmacy Department of Westmead Hospital (unblinded member). The labels for both ointments will be masked and each ointment will be placed in individually numbered envelopes. When a patient with a corneal abrasion presents to the emergency department at Westmead Hospital a detailed ocular examination would be undertaken. If the patient meets our inclusion criteria and informed consent is obtained, the medical officer treating the patient would be provided with a numbered envelope dictated by a randomized matrix and the masked ointment dispensed. The patient would be discharged home with an information leaflet and instructions for use of the ointment. After 2 days, the patient will be asked to represent to the emergency department for follow-up by a specialist trained by the Department of Ophthalmology to detect signs of infection, side effects to treatment and appropriate corneal re-epithelialization and healing. If any signs of infection are noted, the patient will be referred to the Westmead Eye Clinic to be seen by an ophthalmologist on the same day.

The results from this study will be entered into a database and analysed by statisticians with the intension of publishing our findings in international peer-reviewed journals.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30035 0
Address 30035 0
Country 30035 0
Phone 30035 0
Fax 30035 0
Email 30035 0
Contact person for public queries
Name 13282 0
Dr Chameen Samarawickrama
Address 13282 0
Centre for Vision Research,
Westmead Hospital,
Westmead, NSW, 2145
Country 13282 0
Australia
Phone 13282 0
+61 2 9845 6116
Fax 13282 0
+61 2 9845 8345
Email 13282 0
[email protected]
Contact person for scientific queries
Name 4210 0
Dr Chameen Samarawickrama
Address 4210 0
Centre for Vision Research,
Westmead Hospital,
Westmead, NSW, 2145
Country 4210 0
Australia
Phone 4210 0
+61 2 9845 6116
Fax 4210 0
+61 2 9845 8345
Email 4210 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.