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Trial registered on ANZCTR


Registration number
ACTRN12610000991011
Ethics application status
Approved
Date submitted
15/11/2010
Date registered
16/11/2010
Date last updated
12/11/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Dietary supplements and ocular (eye) comfort
Scientific title
A randomised placebo-controlled double-masked study to investigate the effects of dietary supplementation with a combination of omega oils on ocular comfort including symptoms of dry eye
Secondary ID [1] 253081 0
SOVS2010_BK001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ocular comfort including symptoms of dry eye 258646 0
Condition category
Condition code
Eye 258784 258784 0 0
Normal eye development and function
Alternative and Complementary Medicine 258799 258799 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Dietary supplementation with a combination of omega oils. Dosage of EPA (~550mg), DHA (~120mg) and a combination of liolenic acids per 3 capsules per day for 3 months
Intervention code [1] 257601 0
Other interventions
Intervention code [2] 257618 0
Prevention
Comparator / control treatment
Parrafin oil containing capsules. Dosage of three capsules per day for 3 months
Control group
Placebo

Outcomes
Primary outcome [1] 259651 0
Subjective ocular comfort assessed using validated questionnaires (OCI, OSDI, SESOD, numerical rating scales, WHS, DEQ)
Timepoint [1] 259651 0
Baseline, 1 month, 3-month
Secondary outcome [1] 266318 0
Tear Film Stability, volume and composition assessed using NIBUT, osmometry, phenol red thread test
Timepoint [1] 266318 0
Baseline, 3-month
Secondary outcome [2] 266319 0
Lipid layer thickness and meibum composition using tearscope, validated grading scales and spectrum analysis
Timepoint [2] 266319 0
Baseline, 3-month
Secondary outcome [3] 266320 0
Cell and nerve morphology using impression cytology and confocal microscopy
Timepoint [3] 266320 0
Baseline, 3-month

Eligibility
Key inclusion criteria
Willing to comply with the dosage and study visit schedule
Contact lens wearers and non contact lens wearers
At least 18 years old
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Current consumption of omega oil dietary supplements
Moderate or severe dry eye disease
Systematic disease that would preclude participants from safely ingesting dietary supplementation with omega oils
No S3 or above ocular medications
No use of any anticoagulants or blood thinning medications

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation to treatment is conducted following enrolment using numbered containers
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be stratified by contact lens wear. The manufacturer will code, bottle and label study supplies.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
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)
Recruitment postcode(s) [1] 3434 0
2031
Recruitment postcode(s) [2] 3435 0
2033
Recruitment postcode(s) [3] 3436 0
2032
Recruitment postcode(s) [4] 3437 0
2052
Recruitment postcode(s) [5] 3438 0
2035
Recruitment postcode(s) [6] 3439 0
2036
Recruitment postcode(s) [7] 3440 0
2034

Funding & Sponsors
Funding source category [1] 258057 0
Commercial sector/Industry
Name [1] 258057 0
Blackmores Limited
Address [1] 258057 0
20 Jubilee Avenue
Warriewood NSW 2021
Country [1] 258057 0
Australia
Funding source category [2] 258058 0
University
Name [2] 258058 0
University of New South Wales
Address [2] 258058 0
School of Optometry and Vision Science
The Unviersity of New South Wales
UNSW Sydney NSW 2052
Country [2] 258058 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Blackmores Limited
Address
20 Jubilee Avenue
Warriewood NSW 2021
Country
Australia
Secondary sponsor category [1] 257250 0
University
Name [1] 257250 0
University of New South Wales
Address [1] 257250 0
School of Optometry and Vision Science
The Unviersity of New South Wales
UNSW Sydney NSW 2052
Country [1] 257250 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260055 0
Human Research Ethics Committee
Ethics committee address [1] 260055 0
Grant Management Office
The University of New South Wales
UNSW Sydney NSW 2052
Ethics committee country [1] 260055 0
Australia
Date submitted for ethics approval [1] 260055 0
06/04/2010
Approval date [1] 260055 0
25/06/2010
Ethics approval number [1] 260055 0
10110

Summary
Brief summary
This study aims to test whether omega oils taken as capsules can help in improving ocular comfort.
Trial website
http://www.optom.unsw.edu.au/news/2010/Researchrecruit.html
Trial related presentations / publications
1. Jalbert I, Gokhale M, Golebiowski B, Madigan M, Badarudin N, Garg M, Stapleton F. Effect of a combination omega dietary nutraceutical on symptoms of ocular discomfort, clinical indicators and biomarkers of ocular surface health. Optom Vis Sci 2013; 90: E-abstract 130891.
2. Golebiowski B, Hampel U, Badarudin N, Gokhale M, Jalbert I, Madigan M, Stapleton F. Is there a relationship between ocular discomfort and circulating plasma levels of sex hormones? Invest Ophthalmol Vis Sci 2013; 54: ARVO abstract 969.
3. Golebiowski B, Hampel U, Badarudin N, Gokhale M, Madigan M, Jalbert I, Stapleton F. Higher plasma levels of oestradiol are associated with increased ocular discomfort in women. 7th International Conference on the Tear Film & Ocular Surface: Basic Science and Clinical Relevance, Taormina, Italy, September 2013.
4. Hampel U, Golebiowski B, Badarudin N, Jalbert I, Madigan MC, Stapleton F. Is there a relationship between ocular discomfort and circulating 3a-diol-G and DHEA-S serum levels in post-menopausal women? Stapleton F. Higher plasma levels of oestradiol are associated with increased ocular discomfort in women. 7th International Conference on the Tear Film & Ocular Surface: Basic Science and Clinical Relevance, Taormina, Italy, September 2013.
Public notes

Contacts
Principal investigator
Name 31910 0
Dr Isabelle Jalbert
Address 31910 0
School of Optometry and Vision Science
The University of New South Wales
Sydney NSW 2052
Country 31910 0
Australia
Phone 31910 0
+61-2-9385-9816
Fax 31910 0
Email 31910 0
i.jalbert@unsw.edu.au
Contact person for public queries
Name 15157 0
Dr Isabelle Jalbert
Address 15157 0
School of Optometry and Vision Science
The University of New South Wales
Sydney NSW 2052
Country 15157 0
Australia
Phone 15157 0
61-2-9385-9816
Fax 15157 0
61-2-9313-6243
Email 15157 0
i.jalbert@unsw.edu.au
Contact person for scientific queries
Name 6085 0
Dr Isabelle Jalbert
Address 6085 0
School of Optometry and Vision Science
The University of New South Wales
Sydney NSW 2052
Country 6085 0
Australia
Phone 6085 0
61-2-9385-9816
Fax 6085 0
61-2-9313-6243
Email 6085 0
i.jalbert@unsw.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary