ANZCTR - Registration

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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

Condition category

Condition code

Eye

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]

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]

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]

48 hours post discharge from the emergency department after initial presentation.

Primary outcome [2]

corneal re-epithelialization assessed by a qualified examiner via a slit lamp looking for signs of persistent corneal abrasions/ulcers, delayed healing.

Timepoint [2]

48 hours post discharge from the emergency department after initial presentation.

Secondary outcome [1]

side effects of treatment (including local irritation, red eye, swelling of eye lids) assessed by a qualified examiner via a slit lamp.

Timepoint [1]

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?

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]

Self funded/Unfunded

Name [1]

Address [1]

Country [1]

Australia

Primary sponsor type

Hospital

Name

Westmead Hospital

Address

Hawkesbury Road
Westmead, NSW, 2145

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Australia

Ethics approval

Ethics application status

Not yet submitted

Ethics committee name [1]

Westmead Campus Human Research Ethics Committee (HREC)

Ethics committee address [1]

Westmead Hospital,
Westmead, NSW, 2145

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

15/09/2009

Approval date [1]

Ethics approval number [1]

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

Address

Country

Phone

Fax

Contact person for public queries

Name

Dr Chameen Samarawickrama

Address

Centre for Vision Research,
Westmead Hospital,
Westmead, NSW, 2145

Country

Australia

Phone

+61 2 9845 6116

Fax

+61 2 9845 8345

chameen_sama@wmi.usyd.edu.au

Contact person for scientific queries

Name

Dr Chameen Samarawickrama

Address

Centre for Vision Research,
Westmead Hospital,
Westmead, NSW, 2145

Country

Australia

Phone

+61 2 9845 6116

Fax

+61 2 9845 8345

chameen_sama@wmi.usyd.edu.au

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.

Trial Review

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