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Trial registered on ANZCTR


Registration number
ACTRN12612000296831
Ethics application status
Not yet submitted
Date submitted
13/03/2012
Date registered
15/03/2012
Date last updated
15/03/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of 0.5% ketorolac tromethamine eye drop temperature on ocular comfort
Scientific title
For healthy adults aged 18 to 45 years, will refrigeration of 0.5% ketorolac tromethamine eye drops, compared to room temperature ketorolac tromethamine eye drops, improve subjective ocular comfort?
Secondary ID [1] 280114 0
Nil
Universal Trial Number (UTN)
U1111-1129-0614
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ocular discomfort (stinging) during instillation of 0.5% ketorolac tromethamine eyedrops 286032 0
Condition category
Condition code
Eye 286221 286221 0 0
Normal eye development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
1 drop of refrigerated (at approximately 4 degrees Celsius) 0.5% ketorolac tromethamine will be administered in one eye of the subject.
Intervention code [1] 284446 0
Treatment: Drugs
Comparator / control treatment
The wash-out period between treatments is one week. Thus, one week later, 1 drop of room temperature (approximately 22 degrees Celcius) 0.5% ketorolac tromethamine will be administered in the same eye of the subject.
Control group
Active

Outcomes
Primary outcome [1] 286697 0
Ocular comfort as assessed by the Ocular Surface Disease Index questionnaire
Timepoint [1] 286697 0
10 minutes after instillation of eyedrop
Secondary outcome [1] 296482 0
Objective grading of ocular redness after instillation of eyedrop (Using the CCLRU Grading Scale)
Timepoint [1] 296482 0
15 minutes after instillation of eyedrop

Eligibility
Key inclusion criteria
Healthy adults aged 18-45 years
Minimum age
18 Years
Maximum age
45 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
No ocular surface disease, no contact lens wearers

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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
Single group
Other design features
Phase
Phase 4
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
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] 284878 0
University
Name [1] 284878 0
University of New South Wales
Address [1] 284878 0
Anzac Parade
Kensington
2052 NSW
Country [1] 284878 0
Australia
Primary sponsor type
University
Name
University of New South Wales
Address
UNSW
Anzac Parade
Kensington
2052 NSW
Country
Australia
Secondary sponsor category [1] 283756 0
Individual
Name [1] 283756 0
Benjamin Ashby
Address [1] 283756 0
UNSW
Anzac Parade
Kensington 2052
Country [1] 283756 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 286870 0
Ethics committee address [1] 286870 0
Ethics committee country [1] 286870 0
Date submitted for ethics approval [1] 286870 0
01/04/2012
Approval date [1] 286870 0
Ethics approval number [1] 286870 0

Summary
Brief summary
The use of topical ocular non-steroidal anti-inflammatory drugs (NSAIDs) has been limited by the common side effects of burning and stinging. It has been reported that lowering the temperature of lubricant eye drops results in improved ocular comfort. This research project is to determine if refrigeration of 0.5% ketorolac tromethamine prior to administration improves patient tolerability of the commercially available preparation. These findings may lead to an improved method of delivery that will reduce the adverse effect profile of topical NSAIDs, increase patient compliance and influence future prescribing trends.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33899 0
Address 33899 0
Country 33899 0
Phone 33899 0
Fax 33899 0
Email 33899 0
Contact person for public queries
Name 17146 0
Katherine La
Address 17146 0
UNSW
Anzac Parade
Kensington 2052
Country 17146 0
Australia
Phone 17146 0
+61 2 9385 4639
Fax 17146 0
Email 17146 0
katherinela@student.unsw.edu.au
Contact person for scientific queries
Name 8074 0
Katherine La
Address 8074 0
UNSW
Anzac Parade
Kensington 2052
Country 8074 0
Australia
Phone 8074 0
+61 2 9385 4639
Fax 8074 0
Email 8074 0
katherinela@student.unsw.edu.au

No information has been provided regarding IPD availability
Summary results
No Results