NCT01683318

Brief Summary

The current study aims to test the efficacy of treatment for a device that utilises a thermal pulsation system, which applies heat from the inner surface of the eyelids (Lipiflow) in patients suffering from meibomian gland dysfunction. Patients will be asked to undergo a one-time treatment with Lipiflow and the investigators will monitor them for changes in tear film and lipid composition, as well as changes in the anatomy of meibomian glands for over a study period of 12 weeks. Additionally, dry eye symptoms will be documented in form of questionnaires. The investigators hypothesize that the treatment will be effective in improving clinical signs and will relieve dry eye symptoms for the patient. If this method of managing Meibomian Gland Dysfunction (MGD) is found to be efficacious and safe, it will be made available to patients in Singapore.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 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

Study Start

First participant enrolled

September 1, 2012

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

September 4, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 11, 2012

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
Last Updated

November 13, 2013

Status Verified

September 1, 2012

Enrollment Period

1.1 years

First QC Date

September 4, 2012

Last Update Submit

November 11, 2013

Conditions

Meibomian Gland Dysfunction (MGD)

Outcome Measures

Primary Outcomes (1)

  • ocular discomfort

    3 months

Secondary Outcomes (6)

  • Tear Break Up Time (TBUT)

    3 months

  • Number of blocked meibomian glands

    3 months

  • Corneal fluorescein staining score

    3 months

  • To measure the production of tears

    3 months

  • Tear evaporimetry

    3 months

  • +1 more secondary outcomes

Study Arms (1)

Treatment

EXPERIMENTAL

Patients will undergo Thermal Pulsation treatment of Meibomian Gland Dysfunction using the TearScience System (Lipiflow).

Procedure: Thermal Pulsation therapy

Interventions

Thermal Pulsation therapyPROCEDURE
Treatment

Eligibility Criteria

Age21 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 (increased in viscosity or opacity) 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.
  • 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 not permitted by the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Singapore National Eye Centre

Singapore, Singapore, 168751, Singapore

Location

Related Publications (1)

  • 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 Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinician-Scientist

Study Record Dates

First Submitted

September 4, 2012

First Posted

September 11, 2012

Study Start

September 1, 2012

Primary Completion

October 1, 2013

Last Updated

November 13, 2013

Record last verified: 2012-09

Locations

SG(1)