Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000273684
Ethics application status
Approved
Date submitted
31/08/2005
Date registered
2/09/2005
Date last updated
2/09/2005
Type of registration
Prospectively registered

Titles & IDs
Public title
A comparison of topical anaesthesia with placebo for the managment of minor corneal trauma.
Scientific title
Topical anaesthesia (does / does not) delay re-epithelialisation after minor corneal trauma.
Universal Trial Number (UTN)
Trial acronym
MOTE - Minor Ocular Trauma in
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Emergency department presentations of corneal abrasion, corneal foreign bodies and UV keratitis. 361 0
Condition category
Condition code
Eye 423 423 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Dispensing 1.5 mL of eye drops, 0.4% amethocaine, for out-patient management of ocular pain in the first 48hr following the initial emergency department presentation with corneal abrasion, corneal foreign body or UV keratitis.
Intervention code [1] 319 0
Treatment: Drugs
Comparator / control treatment
0.9% saline
Control group
Placebo

Outcomes
Primary outcome [1] 484 0
Is there complete corneal re-epithelialisation (as defined by an absence of fluorescein uptake) at a follow-up visit 36-48hr following discharge from the initial assessment? (yes/no)
Timepoint [1] 484 0
36 - 48 hours following discharge from the intial assessment.
Secondary outcome [1] 1046 0
Quality of analgesia
Timepoint [1] 1046 0
Defined by marking a visual analogue scale every 3hr between initial and follow-up assessments.
Secondary outcome [2] 1047 0
Satisfaction with managment
Timepoint [2] 1047 0
Verbal numeric scale at 2wk following discharge.

Eligibility
Key inclusion criteria
(a) Superficial corneal abrasion with clear history of trauma; (b) superficial corneal abrasion with foreign body; or (c) ultraviolet keratitis with clear history of welding flash exposure.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(a) 36hr or more since event causing the corneal injury; (b) aged under 18yr; (c) history of any of - unacceptable adverse reaction to any local anaesthetic agent or to any ophthalmic preparation, visual impairment secondary to another eye pathology other than simple refractive error, contact lens use, previous participation in this trial, or current pregnancy/lactation; (d) signs of conjunctival infection; (e) functionally one-eyed; or (f) patient requiring referral for ophthalmological opinion.

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)
Numbered containers, blinded contents of which are prepared by a research pharmacist otherwise not involved with the trial. Treatment assignments kept secure at Pharmacy, unavailable to researchers involved with trial recruitment, execution, data collection and data entry until conclusion of trial data collection and entry.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Batches of 16, with 8 amethocaine and 8 placebo assignments in each.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Sample size determined by sequential analysis until data meets pre-defined endpoints supporting or refuting the hypothesis - hence no set sample size provided below.
Phase
Phase 4
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
2/05/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
0
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 475 0
Charities/Societies/Foundations
Name [1] 475 0
Mater Foundation
Country [1] 475 0
Australia
Primary sponsor type
Individual
Name
Ken Barns
Address
Country
Secondary sponsor category [1] 382 0
Individual
Name [1] 382 0
Joseph Ting
Address [1] 382 0
Country [1] 382 0
Secondary sponsor category [2] 383 0
Individual
Name [2] 383 0
John Holmes
Address [2] 383 0
Country [2] 383 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1453 0
Mater Health Services
Ethics committee address [1] 1453 0
South Brisbane Q 4101
Ethics committee country [1] 1453 0
Australia
Date submitted for ethics approval [1] 1453 0
Approval date [1] 1453 0
Ethics approval number [1] 1453 0

Summary
Brief summary
A pilot study to investigate the safety of using local anaesthetic eye drops to control pain following minor corneal injuries.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35812 0
Address 35812 0
Country 35812 0
Phone 35812 0
Fax 35812 0
Email 35812 0
Contact person for public queries
Name 9508 0
Kenneth Barns
Address 9508 0
c/- Department of Emergency Medicine
Mater Adults' Hospital
South Brisbane QLD 4101
Country 9508 0
Australia
Phone 9508 0
+61 7 38408111
Fax 9508 0
+61 7 38401661
Email 9508 0
[email protected]
Contact person for scientific queries
Name 436 0
Kenneth Barns
Address 436 0
c/- Department of Emergency Medicine
Mater Adults' Hospital
South Brisbane QLD 4101
Country 436 0
Australia
Phone 436 0
+61 7 38408111
Fax 436 0
+61 7 38401661
Email 436 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.