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Trial registered on ANZCTR


Registration number
ACTRN12618000856213
Ethics application status
Approved
Date submitted
20/05/2018
Date registered
22/05/2018
Date last updated
22/05/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Can castor oil improve tear film and ocular surface quality?
Scientific title
Evaluation of the ocular surface and tear film effects of topical castor oil application to the eyelids in participants with blepharitis
Secondary ID [1] 294937 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Blepharitis 307910 0
Condition category
Condition code
Eye 306954 306954 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
After training by clinical researchers, participants will topically apply approximately 0.2g of 100% cold pressed castor oil to the external upper and lower eyelid skin surfaces close to the eyelash line. Application will be to one eye only using a dedicated 10ml vial fitted with a roller ball applicator, twice daily (morning and night) for 4 weeks. Treatment compliance will be confirmed by text messaging on day 1 and weekly, with reminders not to apply castor oil on the day of assessment at week 4.
Intervention code [1] 301256 0
Treatment: Other
Comparator / control treatment
The untreated fellow eye serves as the control for comparison. The control eye receives no treatment.
Text messaging will reinforce the need to apply the treatment to just one eye and encourage the participant to check their documentation to ensure they are applying the castor oil to the eyelids of the correct eye.
Control group
Active

Outcomes
Primary outcome [1] 305940 0
Lipid layer grade change of greater than or equal to 1 grade on the Guillon grading scale, evaluated by interferometry using the Oculus Keratograph 5M
Timepoint [1] 305940 0
Baseline, 4 weeks after treatment commencement
Secondary outcome [1] 347080 0
Clinical blepharitis grade as assessed by slit lamp examination
Timepoint [1] 347080 0
Baseline, 4 weeks after treatment commencement
Secondary outcome [2] 347081 0
Non-invasive tear film stability as measured by the Oculus Keratograph 5M
Timepoint [2] 347081 0
Baseline, 4 weeks after treatment commencement
Secondary outcome [3] 347082 0
Discomfort symptoms (on the Ocular Surface Disease Index validated questionnaire)
Timepoint [3] 347082 0
Baseline, 4 weeks after treatment commencement
Secondary outcome [4] 347083 0
Bulbar hyperaemia as assessed objectively with the Oculus Keratograph 5M
Timepoint [4] 347083 0
Baseline, 4 weeks after treatment commencement

Eligibility
Key inclusion criteria
Aged over 18 years
Clinical signs and symptoms of anterior blepharitis
Symmetry in signs and symptoms of both eyes at baseline
Crusting of the eyelashes and/or signs of meibomian gland dysfunction
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Current topical use of eye drops other than occasional use of artificial tears
Current active infection
Abnormal eyelid architecture that prevents full eyelid closure during blinking
Use of systemic medications that are known to affect the lacrimal system (cause eye dryness)
Changed or planned change in systemic medication within 4 weeks of study commencement


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)
Participants will be informed about which eye to treat via written instructions provided in a sealed opaque envelope.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequence generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Paired eye design - one eye (randomised) will receive treatment in each individual and the fellow eye will not receive any treatment.
Phase
Phase 2
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Power calculation indicates a minimum sample size of 16 to show a significant difference (at p<0.05 with 80% power) in lipid layer grade. However for differences in the secondary outcomes a larger sample size (of n=55) is required.

Repeated measures ANOVA for data confirmed to be normally distributed by the Kolomogarov Smirnoff test of normality. A Friedmann test (non-parametric equivalent) for ordinal data.

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 outside Australia
Country [1] 10412 0
New Zealand
State/province [1] 10412 0
Auckland

Funding & Sponsors
Funding source category [1] 299522 0
University
Name [1] 299522 0
The University of Auckland
Address [1] 299522 0
Private Bag 92019
Auckland 1142
Country [1] 299522 0
New Zealand
Primary sponsor type
University
Name
The University of Auckland
Address
Private Bag 92019
Auckland 1142
Country
New Zealand
Secondary sponsor category [1] 298822 0
None
Name [1] 298822 0
Address [1] 298822 0
Country [1] 298822 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300419 0
The University of Auckland Human Participants Ethics Committee
Ethics committee address [1] 300419 0
Private Bag 92019
Auckland 1142
Ethics committee country [1] 300419 0
New Zealand
Date submitted for ethics approval [1] 300419 0
28/02/2018
Approval date [1] 300419 0
13/04/2018
Ethics approval number [1] 300419 0
020783

Summary
Brief summary
Eyedrops containing castor oil can be used to relieve symptoms of dry eye disease. This study seeks to determine if the application of castor oil to the eyelids improves the eyelid margin health and the tear film quality. This is a prospective, investigator-masked, paired-eye trial where one eye of each participant with bilateral anterior blepharitis will be selected for castor oil application according to a computerised randomisation schedule created pre-recruitment. The fellow eye will remain untreated, as the control. Clinicians collecting data will be masked with respect to the eye that has been assigned castor oil application. Participants will be asked to refrain from applying castor oil on the day of assessment to minimise the risk of unmasking.
Pre-treatment signs & symptoms will be measured using validated, non-invasive dry eye clinical tests.
Following 4 weeks of twice daily application of castor oil to both upper and lower eyelids with a roller ball applicator, post-treatment signs and symptoms will be remeasured and compared to baseline. The battery of tests will take up to 45 minutes to perform at each visit and will include clinical tests and patient reported outcomes via symptom questionnaires.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 83602 0
A/Prof Jennifer P Craig
Address 83602 0
Department of Ophthalmology
The University of Auckland
Private Bag 92019
Auckland 1142
Country 83602 0
New Zealand
Phone 83602 0
+6499238173
Fax 83602 0
Email 83602 0
jp.craig@auckland.ac.nz
Contact person for public queries
Name 83603 0
A/Prof Jennifer P Craig
Address 83603 0
Department of Ophthalmology
The University of Auckland
Private Bag 92019
Auckland 1142
Country 83603 0
New Zealand
Phone 83603 0
+6499238173
Fax 83603 0
Email 83603 0
jp.craig@auckland.ac.nz
Contact person for scientific queries
Name 83604 0
A/Prof Jennifer P Craig
Address 83604 0
Department of Ophthalmology
The University of Auckland
Private Bag 92019
Auckland 1142
Country 83604 0
New Zealand
Phone 83604 0
+6499238173
Fax 83604 0
Email 83604 0
jp.craig@auckland.ac.nz

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