NCT01448369

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 4, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 7, 2011

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2011

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

June 10, 2014

Status Verified

June 1, 2014

Enrollment Period

2 years

First QC Date

October 4, 2011

Last Update Submit

June 9, 2014

Conditions

Meibomian Gland Dysfunction

Keywords

meibomian gland dysfunctionhot compresseyelid warmingmeibum

Outcome Measures

Primary Outcomes (1)

  • Dry Eye Symptoms

    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.

    Week 4

Secondary Outcomes (9)

  • Tear film break up time

    Week 4

  • Number of plugs

    Week 4

  • Yamaguchi Score

    Week 4

  • Corneal Staining

    Week 4

  • Schirmer's Test

    Week 4

  • +4 more secondary outcomes

Study Arms (3)

EyeGiene

ACTIVE COMPARATOR

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

Blephasteam

ACTIVE COMPARATOR

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

Control- Hot Compress

PLACEBO COMPARATOR

The participants in this group will be using warm compresses with a hot towel.

Device: Hot compresses

Interventions

BlephasteamDEVICE

10 minute treatment twice daily

Also known as: Spectrum Théa, France
Blephasteam
EyeGieneDEVICE

10 minute treatment, twice daily

Also known as: Eyedetec Medical Inc., US
EyeGiene
Hot compressesDEVICE

10 minute treatment, twice daily

Control- Hot Compress

Eligibility Criteria

Age21 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Singapore National Eye Centre/ Singapore Eye Research Institute

Singapore, Singapore, 168751, Singapore

Location

Related Publications (3)

  • 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. doi: 10.1016/S0161-6420(03)00262-8.

    PMID: 12799232BACKGROUND

  • Foulks GN, Borchman D. Meibomian gland dysfunction: the past, present, and future. Eye Contact Lens. 2010 Sep;36(5):249-53. doi: 10.1097/ICL.0b013e3181ef0d37.

    PMID: 20724853BACKGROUND

  • Yeo S, Tan JH, Acharya UR, Sudarshan VK, Tong L. Longitudinal Changes in Tear Evaporation Rates After Eyelid Warming Therapies in Meibomian Gland Dysfunction. Invest Ophthalmol Vis Sci. 2016 Apr 1;57(4):1974-81. doi: 10.1167/iovs.16-19088.

    PMID: 27096755DERIVED

MeSH Terms

Conditions

Meibomian Gland Dysfunction

Condition Hierarchy (Ancestors)

Eyelid DiseasesEye Diseases

Study Officials

  • Louis Tong, PhD

    Singapore National Eye Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinician-Scientist, Consultant

Study Record Dates

First Submitted

October 4, 2011

First Posted

October 7, 2011

Study Start

December 1, 2011

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

June 10, 2014

Record last verified: 2014-06

Locations

SG(1)