Eyelid Warming Technology for Meibomian Gland Dysfunction - Full Text View

Purpose

Meibomian gland dysfunction (MGD), an extremely common clinical condition (seen in more than half of some Asian populations), affects the lipid producing meibomian glands in the eyelids. One function of the glandular secretions is to reduce evaporation of the tear film. In MGD the meibomian glands may become blocked for various reasons. The consequential retention and stasis of the secretion increases immune response as well as scarring response. This eventually results in an abnormal tear film and dry eye symptoms.

The current standard treatments include warm moist compresses, regular lid hygiene, oral antibiotics, topical antibiotic ointments and Omega 3 supplementation. Heating for an extended duration is important because it relieves the occlusion of blocked meibomian glands. However, improvised methods of heating are cumbersome and inefficient requiring repeated measures, often leading to lack of compliance. Today, there is a wider range of commercially available devices that help to unblock meibomian glands and relief dry eye symptoms. These devices may improve MGD treatment dramatically, but have not been tested in the warm climate of Singapore, and are not readily available.

The current study aims to test the efficacy of treatment for devices that utilize A) warm moisture (Blephasteam) and B) warmth (EyeGiene) in patients suffering from meibomian gland dysfunction. Patients will be asked to use Blephasteam and EyeGiene for a period of 4 weeks. The study will monitor patients for changes in tear film and lipid composition, as well as changes in the anatomy of meibomian glands. Additionally, dry eye symptoms will be documented in form of questionnaires. If the newer methods of managing MGD are found to be efficacious and safe, these treatment measures can be made available to patients in Singapore.

Condition	Intervention
Meibomian Gland Dysfunction	Device: Blephasteam Device: EyeGiene Device: Hot compresses

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Treatment
Official Title:	Eyelid Warming Technology for Relief of Meibomian Gland Dysfunction in an Asian Population

Further study details as provided by Singapore National Eye Centre:

Primary Outcome Measures:

Dry Eye Symptoms [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
A VAS will be applied to evaluate dry eye symptoms as described by Schaumberg et al. (Schaumberg 2007)between baseline and week 4. The scores will be recorded separately for frequency and severity of dry eye symptoms.

Secondary Outcome Measures:

Tear film break up time [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
After instillation of fluorescein, the participant will be asked to open the eyes, look ahead at the observer's forehead and not blink for as long as possible. The break up time is defined as the time between the lid opening and the first appearance of any dry spot on the cornea. The participant will be requested to close his eyes for few seconds and the procedure will be repeated for the left eye. The tear film break up time will be compared between baseline and week 4.
Number of plugs [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
The number of blocked/plugged meibomian glands will be counted in each eyelid and any improvement in comparison to baseline assessed.
Yamaguchi Score [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
The severity of meibomian gland dysfunction will be assessed at baseline and week 4.
Corneal Staining [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
The corneal staining will be assessed using fluorescein. The cornea will be divided into 5 sectors. The staining will be assessed at baseline and week 4.
Schirmer's Test [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
The tear production will be assessed using Schirmer Test I. Improvements in tear production will be identified in comparison to baseline.
Meibography [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
The meibomian glands will be imaged using infrared photography and their health graded at baseline and week 4.
Tear meniscus volume [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
The tear meniscus (height of the tear film) will be imaged and measured using the Anterior segment optical coherence tomography (AS-OCT). Briefly, the participant will be asked to look at a target in the instrument while blinking normally. The OCT will then scan the ocular surface and images of the upper and lower tear meniscus will be captured. Any changes in tear volume will be assessed with comparison to baseline values.
Meibomian gland lipids [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
The meibum from patients will be collected using a Kimura Platinum spatula and the lipid components will be analysed using mass-spectrometry. Lipid compositions will be compared between baseline and week 4 visits.
Tear composition [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
The Schirmer test strips will be collected and the tears analysed for protein and lipid changes at baseline and after 4 weeks of treatment.

Estimated Enrollment:	75
Study Start Date:	December 2011
Estimated Study Completion Date:	December 2013
Estimated Primary Completion Date:	December 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: EyeGiene EyeGiene (Eyedetec Medical Inc., US) is a self-contained, convenient warm compress system for the eyes. The system is composed of a reusable eye mask and one time use warmers that are inserted into the eye mask. The warming units are activated by squeezing just prior use and deliver 40°C heat for up to 5 minutes within 30-60 seconds.	Device: EyeGiene 10 minute treatment, twice daily Other Name: Eyedetec Medical Inc., US
Active Comparator: Blephasteam Blephasteam (Spectrum Théa, France) is an eyelid warming device that can be conveniently used at home. The goggles provide standardised heat of about 38 degrees to liquefy lipids and also humidify the chambers with mineral water to ensure optimal moisture levels.	Device: Blephasteam 10 minute treatment twice daily Other Name: Spectrum Théa, France
Placebo Comparator: Control The participants in this group will be using warm compresses with a hot towel.	Device: Hot compresses 10 minute treatment, twice daily

Show Detailed Description

Eligibility

Ages Eligible for Study:	21 Years to 90 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Eyelids must present with blocked meibomian gland openings (plugs), at least 1 visible MG plug in the 4 eyelids, or discernable change in consistency of meibum when MG expressed in upper or lower eyelids.
At least one out of 8 questions on dry eye symptoms is answered with often or all the time (Appendix C, Questionnaire modified after Schein et al.,1997).
Eyes should not show any other ocular surface pathology which required more treatment than eye lubricant and conventional eyelid hygiene.

Exclusion Criteria:

Known history of thyroid disorders (diagnosed by physician).
No ocular surgery within the previous 6 months and LASIK within the previous 1 year.
Any intake of central nervous system and hormonal drugs within last 30 days and inability to withhold such drugs for at least 6 weeks.
Active ocular infection or pterygium.
Anticipated necessity to wear contact lens in the duration of the study.
Living in the same household as another participant of the study.
Any other specified reason as determined by clinical investigator, for example, the need to use any treatment or eyedrops (eg. Restasis) not permitted by the study.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01448369

Contacts

Contact: Louis Tong, PhD	+656327 ext 5890	louis.tong.h.t@snec.com.sg
Contact: Andrea Petznick, PhD	+656557 ext 4065	andrea.petznick@seri.com.sg

Locations

Singapore
Singapore National Eye Centre/ Singapore Eye Research Institute	Recruiting
Singapore, Singapore, 168751
Contact: Louis Tong, MD, PhD +65 6327 ext 5890 louis.tong.h.t@snec.com.sg
Contact: Andrea Petznick, PhD +65 6327 ext 5800 andrea.petznick@seri.com.sg
Sub-Investigator: Andrea Petznick, PhD

Sponsors and Collaborators

Singapore National Eye Centre

Singapore Eye Research Institute

National University, Singapore

Investigators

Principal Investigator:

Louis Tong, PhD

Singapore National Eye Centre

More Information

Publications:

Lin PY, Tsai SY, Cheng CY, Liu JH, Chou P, Hsu WM. Prevalence of dry eye among an elderly Chinese population in Taiwan: the Shihpai Eye Study. Ophthalmology. 2003 Jun;110(6):1096-101.

Foulks GN, Borchman D. Meibomian gland dysfunction: the past, present, and future. Eye Contact Lens. 2010 Sep;36(5):249-53. Review.

Responsible Party:	Louis Tong, Clinician-Scientist, Consultant, Singapore National Eye Centre
ClinicalTrials.gov Identifier:	NCT01448369 History of Changes
Other Study ID Numbers:	R815/10/2011, 2011/197/A
Study First Received:	October 4, 2011
Last Updated:	January 30, 2013
Health Authority:	Singapore: Health Sciences Authority

Keywords provided by Singapore National Eye Centre:

meibomian gland dysfunction
hot compress
eyelid warming
meibum

ClinicalTrials.gov processed this record on May 19, 2013