Trial Review

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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 781 0
Condition category
Condition code
Eye 855 855 0 0
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] 704 0
None
Comparator / control treatment
Placebo (hypromellose 0.5% eye drop) for a period of 24 hours.
Control group
Placebo

Outcomes
Primary outcome [1] 1097 0
The main outcome measure is the measurement of pain on the visual analogue scale (VAS) score
Timepoint [1] 1097 0
At 0, 6, 12, 18 and 24 hours after administration of the randomised eye drop.
Secondary outcome [1] 2032 0
None
Timepoint [1] 2032 0

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?
No
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
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 941 0
Government body
Name [1] 941 0
Southern Health
Country [1] 941 0
Australia
Primary sponsor type
Government body
Name
Southern Health
Address
Country
Australia
Secondary sponsor category [1] 801 0
None
Name [1] 801 0
n/a
Address [1] 801 0
Country [1] 801 0

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 36014 0
Address 36014 0
Country 36014 0
Phone 36014 0
Fax 36014 0
Email 36014 0
Contact person for public queries
Name 9893 0
Andy Sullivan
Address 9893 0
Pharmacy Department
Dandenong Hospital
David Street
Dandenong VIC 3175
Country 9893 0
Australia
Phone 9893 0
+61 3 95548191
Fax 9893 0
Email 9893 0
[email protected]
Contact person for scientific queries
Name 821 0
Dr. Robert Meek
Address 821 0
Emergency Department
Dandenong Hospital
David Street
Dandenong VIC 3175
Country 821 0
Australia
Phone 821 0
+61 3 95548177
Fax 821 0
+61 3 95548453
Email 821 0
[email protected]

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What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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