ANZCTR - Registration

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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]

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

Condition category

Condition code

Eye

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]

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]

Tear film lipid layer thickness (measured with Lipiview)

Timepoint [1]

Baseline
immediately after, 15 minutes and then 1 hour after intervention

Secondary outcome [1]

- subjective symptoms of dry eyes: measured by a dry eye questionnaire used (OSID Questionnaire)

Timepoint [1]

baseline
immediately after, 15 minutes and then 1 hour after intervention

Secondary outcome [2]

- tear break up time: measured under slit lamp biomicroscopy using cobalt blue lighting and with fluorescein dye instilment to the eye

Timepoint [2]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Funding & Sponsors

Funding source category [1]

University

Name [1]

University of New South Wales

Address [1]

UNSW Australia High St Kensington, NSW 2052. Australia.

Country [1]

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]

Individual

Name [1]

Lily Ho

Address [1]

room 1.064
School of Optometry and Vision Sciene Building
UNSW Australia High St Kensington, NSW 2052. Australia.

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

HREA Panel Biomedical

Ethics committee address [1]

Ethics committee country [1]

Date submitted for ethics approval [1]

05/05/2015

Approval date [1]

25/06/2015

Ethics approval number [1]

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

Dr Jacqueline Tan

Address

Room 3.024
School of Optometry and Vision Science Building,
University of New South Wales Australia
High St
Kensington, NSW 2052
Australia

Country

Australia

Phone

+61 2 9385 6551

Fax

jacqueline.tan@unsw.edu.au

Contact person for public queries

Name

Sylbi Lee

Address

School of Optometry and Vision Science Building,
University of New South Wales Australia
High St
Kensington, NSW 2052
Australia

Country

Australia

Phone

+61404069553

Fax

sylbijlee@gmail.com

Contact person for scientific queries

Name

Sylbi Lee

Address

School of Optometry and Vision Science Building,
University of New South Wales Australia
High St
Kensington, NSW 2052
Australia

Country

Australia

Phone

+61404069553

Fax

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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Documents added automatically

No additional documents have been identified.

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