Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000706572
Ethics application status
Approved
Date submitted
17/05/2015
Date registered
8/07/2015
Date last updated
8/07/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Assessing how effective the Bruder Eye Hydrating Compress is in the treatment of Meibomian Gland Dysfunction compared to Traditional Warm Compress
Scientific title
Assessing how effective the Bruder Eye Hydrating Compress is in the treatment of Meibomian Gland Dysfunction (MGD) compared to Traditional Warm Compress
Secondary ID [1] 286652 0
NIL
Universal Trial Number (UTN)
U1111-1169-9546
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Meibomian Gland Dysfunction 294984 0
Condition category
Condition code
Eye 295249 295249 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Bruder Eye Hydrating Compress (mask applied once for 5 minutes)

The Bruder Eye Hydrating Compress is a microwave activated moist heat compress intended to stimulate the meibomian glands, in order to increase lipid secretion and slow tear evaporation to bring relief for dry eye sufferers. It is considered superior to conventional treatments using warm face cloths, as the MediBeads technology incorporated in to the design of the mask eliminates the need for repeated rinsing and wringing out of the face cloth to maintain adequate heat for the required duration.

All participants will receive both the Bruder Eye Hydrating Compress and the traditional warm compress. The 'wash out' period between treatments is 2 weeks
Intervention code [1] 291796 0
Treatment: Devices
Comparator / control treatment
Traditional Warm Compress (hot wet towel at 40 degress applied for 5 minutes, replaced every 2 minutes)
Control group
Active

Outcomes
Primary outcome [1] 294997 0
Tear film lipid layer thickness (measured with Lipiview)
Timepoint [1] 294997 0
Baseline
immediately after, 15 minutes and then 1 hour after intervention
Secondary outcome [1] 314547 0
- subjective symptoms of dry eyes: measured by a dry eye questionnaire used (OSID Questionnaire)
Timepoint [1] 314547 0
baseline
immediately after, 15 minutes and then 1 hour after intervention
Secondary outcome [2] 314989 0
- tear break up time: measured under slit lamp biomicroscopy using cobalt blue lighting and with fluorescein dye instilment to the eye
Timepoint [2] 314989 0
baseline
immediately after, 15 minutes and then 1 hour after intervention

Eligibility
Key inclusion criteria
18 years old and older
dry eye symptoms due to MGD
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria (1 month prior and during the study):
- Taking medications or supplements
- Any other eye complications requiring treatment other than eye lubricants
- Eye infection or surgery
- Wearing contact lenses
- Other systemic conditions e.g. rheumatoid arthritis, thyroid dysfunction, skin conditions such as acne rosacea

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
20/07/2015
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 291226 0
University
Name [1] 291226 0
University of New South Wales
Country [1] 291226 0
Australia
Primary sponsor type
Individual
Name
Dr Jacqueline Tan
Address
Room 3.024
School of Optometry and Vision Sciene Building
UNSW Australia High St Kensington, NSW 2052. Australia.
Country
Australia
Secondary sponsor category [1] 289902 0
Individual
Name [1] 289902 0
Lily Ho
Address [1] 289902 0
room 1.064
School of Optometry and Vision Sciene Building
UNSW Australia High St Kensington, NSW 2052. Australia.
Country [1] 289902 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292786 0
HREA Panel Biomedical
Ethics committee address [1] 292786 0
Ethics committee country [1] 292786 0
Date submitted for ethics approval [1] 292786 0
05/05/2015
Approval date [1] 292786 0
25/06/2015
Ethics approval number [1] 292786 0
HC15322

Summary
Brief summary
Dry eye symptoms associated with Meibomian Gland Dysfunction (MGD) is a commonly encountered complication in optometric care. MGD refers to the abnormal functioning of the meibomian glands located at the eyelids. Meibomian glands are normally responsible for secreting oils which maintain proper hydration of the eyes.
Management and treatment options for the relief of MGD complications such as sensations of dry eyes, grittiness, and discomfort of the eyes, have been widely investigated in the literature. The current mainstay treatment for MGD is an application of heat on to the eyelid surface by the use of a warm compress (usually a face cloth wrung under hot water) which have shown to be effective in the relief of dry eye symptoms and discomfort of the eyes. More recent studies have investigated the efficacy of different heating devices to treat MGD.
Our study aims to evaluate the effect of the Bruder Eye Hydrating Compress on symptoms of dry eyes and discomfort, and the presentation of the eye in subjects with dry eye associated with MGD.
The Bruder Eye Hydrating Compress is a microwave activated moist heat compress intended to stimulate the meibomian glands, in order to increase lipid secretion and slow tear evaporation to bring relief for dry eye sufferers. It is considered superior to conventional treatments using warm face cloths, as the MediBeads technology incorporated in to the design of the mask eliminates the need for repeated rinsing and wringing out of the face cloth to maintain adequate heat for the required duration. However, no studies to date have evaluated the effect of the Bruder Eye Hydrating Compress on ocular symptoms and signs.
This study will utilise questionnaires to evaluate eye symptoms, as well as traditional and advanced diagnostic tools and techniques, to evaluate eye surface characteristics after treatment with the Bruder Eye Hydrating Compress in subjects with MGD
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 57030 0
Dr Jacqueline Tan
Address 57030 0
Room 3.024
School of Optometry and Vision Science Building,
University of New South Wales Australia
High St
Kensington, NSW 2052
Australia
Country 57030 0
Australia
Phone 57030 0
+61 2 9385 6551
Fax 57030 0
Email 57030 0
jacqueline.tan@unsw.edu.au
Contact person for public queries
Name 57031 0
Miss Sylbi Lee
Address 57031 0
School of Optometry and Vision Science Building,
University of New South Wales Australia
High St
Kensington, NSW 2052
Australia
Country 57031 0
Australia
Phone 57031 0
+61404069553
Fax 57031 0
Email 57031 0
sylbijlee@gmail.com
Contact person for scientific queries
Name 57032 0
Miss Sylbi Lee
Address 57032 0
School of Optometry and Vision Science Building,
University of New South Wales Australia
High St
Kensington, NSW 2052
Australia
Country 57032 0
Australia
Phone 57032 0
+61404069553
Fax 57032 0
Email 57032 0
sylbijlee@gmail.com

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

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