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Trial registered on ANZCTR


Registration number
ACTRN12608000342314
Ethics application status
Approved
Date submitted
15/07/2008
Date registered
22/07/2008
Date last updated
22/07/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
Improving diagnosis and treatment of lid disease
Scientific title
Establishing diagnostic criteria and optimising contemporary therapies for meibomian gland dysfunction by using three management strategies: latent heat goggles, warm compresses and liposomal spray
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Meibomian gland dysfunction 3408 0
Condition category
Condition code
Eye 3557 3557 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Three management strategies are to be used:
Latent Heat Goggles, Warm Compresses with a flaxseed pouch, and a Liposomal Spray. The latent heat goggles will be worn for 10 minutes at the 50°C setting. The treatment will be carried out two times within the overall intervention period of 4 hours. The warm compresses (flaxseed pouch) will be heated in a 900W microwave for 30 seconds as per the manufacturers instructions, and then applied to the closed eyes for 5 minutes. The treatment will be performed two times within the overall intervention period of 4 hours. A single application the liposomal spray (TearsAgain) which contains soy lecithin 1.0% will be applied to the closed eye, as per normal patient instructions. The treatment will be applied two times within the overall intervention period of 4 hours.
Intervention code [1] 3133 0
Treatment: Devices
Intervention code [2] 3134 0
Diagnosis / Prognosis
Intervention code [3] 3135 0
Treatment: Drugs
Comparator / control treatment
Comparator treatments: latent heat goggles vs. warm compresses vs. liposomal spray
Control group
Active

Outcomes
Primary outcome [1] 4492 0
Therapies for meibomian gland dysfunction will be optimised on the basis of the tear film evaporation rate.
Timepoint [1] 4492 0
30 minutes and 1 hour following intervention
Secondary outcome [1] 7600 0
Secondary outcome is the temperature profile of the ocular surface and adnexa, measured with a non-contact infra-red thermographer
Timepoint [1] 7600 0
30 minutes and 1 hour following intervention

Eligibility
Key inclusion criteria
Symptoms and signs of meibomian gland dysfunction
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1: major systemic or ophthalmic disease other than MGD
2: history of anterior eye surgery
3: marginal eyelid disease under treatment at the time of presentation
- contact lens wearers

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)
Potential participants will be identified from outpatient ophthalmology clinics. Informed consent will be obtained prior to participation in the study. Participants will be randomly allocated in a concealed manner into one of the three treatment groups in an investigator-masked fashion.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomly allocated into one of the three treatment groups in equal numbers,using computer-generated random numbers (central randomisation by computer)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
21/07/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment outside Australia
Country [1] 1041 0
New Zealand
State/province [1] 1041 0
Auckland

Funding & Sponsors
Funding source category [1] 3595 0
University
Name [1] 3595 0
Faculty Research Development Fund
Country [1] 3595 0
New Zealand
Primary sponsor type
University
Name
Department of Optometry and Vision Science
Address
University of Auckland
Private Bag 92019
Auckland 1142
Country
New Zealand
Secondary sponsor category [1] 3231 0
None
Name [1] 3231 0
Address [1] 3231 0
Country [1] 3231 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5669 0
Northern Y Regional Ethics Committee
Ethics committee address [1] 5669 0
C/- Ministry of Health
3rd floor, BNZ Building, 354 Victoria Street
PO Box 1031, Hamilton 3240
Ethics committee country [1] 5669 0
New Zealand
Date submitted for ethics approval [1] 5669 0
10/07/2008
Approval date [1] 5669 0
Ethics approval number [1] 5669 0
Pending
Ethics committee name [2] 5671 0
University of Auckland Human Participants Ethics Committee
Ethics committee address [2] 5671 0
University of Auckland
Private Bag 92019
Auckland 1142
Ethics committee country [2] 5671 0
New Zealand
Date submitted for ethics approval [2] 5671 0
18/01/2008
Approval date [2] 5671 0
20/02/2008
Ethics approval number [2] 5671 0
UAHPEC 2008/033

Summary
Brief summary
Meibomian gland dysfunction (MGD) is a common, chronic eyelid disease, which can cause the affected individual to suffer from debilitating dry eye symptoms. Due to the multifaceted aetiology of dry eye, and often poor correlation between signs and symptoms, dry eye conditions are regularly misdiagnosed and mismanaged in clinical practice. This project plans to evaluate subjects with a range of meibomian gland dysfunction severity using a battery of sensitive, non-invasive tests. The results of the tests will be used to develop superior diagnostic criteria for this condition. We then plan to evaluate three contemporary methods for treating MGD, namely, latent heat goggles, warm compresses with a flaxseed pouch, and a liposomal spray, to establish the optimal treatment conditions, across the range of MGD severities, in order that clinicians may provide more sound, evidence-based recommendations to their patients in the management of the condition.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28749 0
Address 28749 0
Country 28749 0
Phone 28749 0
Fax 28749 0
Email 28749 0
Contact person for public queries
Name 11906 0
Dr. Jennifer P. Craig
Address 11906 0
Department of Optometry and Vision Science
University of Auckland
Private Bag 92019
Auckland 1142
Country 11906 0
New Zealand
Phone 11906 0
+64 9 373 7599 ext 88173
Fax 11906 0
+ 64 9 308 2342
Email 11906 0
[email protected]
Contact person for scientific queries
Name 2834 0
Dr. Jennifer P. Craig
Address 2834 0
Department of Optometry and Vision Science
University of Auckland
Private Bag 92019
Auckland 1142
Country 2834 0
New Zealand
Phone 2834 0
+64 9 373 7599 ext 88173
Fax 2834 0
+ 64 9 308 2342
Email 2834 0
[email protected]

No information has been provided regarding IPD availability


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No Supporting Document Provided



Results publications and other study-related documents

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