ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12605000648628

Ethics application status

Approved

Date submitted

7/10/2005

Date registered

17/10/2005

Date last updated

17/10/2005

Type of registration

Prospectively registered

Titles & IDs

Public title

Is Homatropine 5% effective in reducing pain associated with corneal abrasion when compared to placebo?

Scientific title

Is Homatropine 5% effective in reducing pain associated with corneal abrasion when compared to placebo?

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Corneal Abrasion

Condition category

Condition code

Eye

Diseases / disorders of the eye

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

The study will be a double blind randomised controlled trial with parallel groups receiving either the active agent (homatropine 5% eye drop).

Intervention code [1]

None

Comparator / control treatment

Placebo (hypromellose 0.5% eye drop) for a period of 24 hours.

Control group

Placebo

Outcomes

Primary outcome [1]

The main outcome measure is the measurement of pain on the visual analogue scale (VAS) score

Timepoint [1]

At 0, 6, 12, 18 and 24 hours after administration of the randomised eye drop.

Secondary outcome [1]

None

Timepoint [1]

Eligibility

Key inclusion criteria

Corneal abrasion or ulceration from trauma (any cause, excluding chemical burn), defined as visualisation of fluorescein uptake on slit lamp examination, patient must have not undergone any prior eye examination/intervention and/or received topical therapies to the eye within 48 hours before the injury.

Minimum age

18 Years

Maximum age

Not stated

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Non-traumatic Corneal Ulceration such as flash burn, suspected viral or other infection, patients less than 18 years old, pregnancy, breastfeeding mothers, allergy to any medications involved in the study, glaucoma, bilateral abrasion, patients who cannot read and/or understand the patient information for whatever reason or are unwilling to give consent to participate, keratoconus.

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)

Sixty opaque envelopes will be prepared and numbered one to sixty. These will be in the possession of an independent pharmacist who will then prepare the bottles of study medication. The independent pharmacist will have no active or ongoing involvement in the conduct of the study after initial preparation of the study medications.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

A pharmacist independent to the study will generate a random number sequence (from one to sixty) using a random number table from a standard textbook (Geigy Scientific Tables, Vol. 2. 8th edn. Ciba-Geigy Ltd.) to randomise the order for use of either the homatropine 5% eye drops or the hypromellose 0.5% eye drops. The first thirty random numbers will be allocated to the homatropine 5% group and the remaining thirty random numbers will be allocated to the hypomellose 0.5% group.

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Phase

Type of endpoint/s

Efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

1/12/2005

Actual

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Southern Health

Address [1]

Country [1]

Australia

Primary sponsor type

Government body

Name

Southern Health

Address

Country

Australia

Secondary sponsor category [1]

None

Name [1]

n/a

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Summary

Brief summary

Corneal abrasion or ulceration following trauma is the most common ophthalmological condition which presents to Emergency Departments. The cornea is the clear covering over the iris (coloured part of the eye) which is usually injured by objects hitting the surface of the eye (eg during grinding metal or fingernail scratches).  Because of the large number of nerve endings in the cornea, surface damage is generally very painful, especially in the first 24 hours.  Despite minor corneal trauma being common, the management remains controversial.  There is general agreement that oral analgesics should be recommended and that topical antibiotics should be prescribed, although this has been debated.
It has been thought in the past that spasm of the eye muscles around the pupil (dark part of the eye) might add to the pain which people experience after minor corneal trauma. A number of eye drops can paralyse these muscles so that this does not occur.  This means that the pupil remains large and cannot alter in size in response to changes in light or attempts to focus.  This leads to some light sensitivity and blurring of vision, which also occur anyway when the cornea is injured.  Some text books recommend use of pupil dilating drops after corneal injury, but a recent literature review on the topic did not recommend their use because one study found no benefit.  A recent survey of emergency physicians in Canada found that now only just over half of them are using dilating drops in this setting.   
This project aims to determine if homatropine 5% (a strong pupil dilating drop) given every six hours for a twenty-four period is effective in reducing eye pain associated with minor corneal abrasion. 
A total of 60 patients will be asked to participate in this study. Patients will be recruited by doctors working in the emergency department at Dandenong Hospital. Patients who satisfy the trial entry criteria will be asked to instil either homatropine 5% eye drops or hypromellose 0.5% eye drops (inactive placebo).  All patients will be prescribed an antibiotic eye ointment to prevent infection in the affected eye. Patients will also be given paracetamol tablets with direction to take two tablets every six hours when required for pain.
The visual analogue scale (VAS) will be used in this study to measure the level of pain in patients with corneal abrasion. Statistical analysis will involve comparing the mean pain scores at 0, 6, 12, 18 and 24 hours to find if there is a clinically significant difference between homatropine 5% and hypromellose (placebo). A reduction in VAS score of more than 20mm is considered clinically significant, so a change of this level would support future homatropine use, while a lesser change would not.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Address

Country

Phone

Fax

Contact person for public queries

Name

Andy Sullivan

Address

Pharmacy Department
Dandenong Hospital
David Street
Dandenong VIC 3175

Country

Australia

Phone

+61 3 95548191

Fax

andy.sullivan@southernhealth.org.au

Contact person for scientific queries

Name

Dr. Robert Meek

Address

Emergency Department
Dandenong Hospital
David Street
Dandenong VIC 3175

Country

Australia

Phone

+61 3 95548177

Fax

+61 3 95548453

robertmeek66@hotmail.com

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.

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