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Investigating the Effect of At Home Thermal Therapy on Dry Eye Patients With Meibomian Gland Dysfunction

U

UMay Care

Status

Unknown

Conditions

Meibomian Gland Dysfunction
Dry Eye Disease

Treatments

Device: Thermal therapy device

Study type

Interventional

Funder types

Industry

Identifiers

NCT03291704
Meibomian Gland Dysfunction

Details and patient eligibility

About

The purpose of this pilot study is to determine the feasibility of at home thermal therapy with a wireless, portable device, as an effective management of Meibomian Gland Dysfunction.

This will be done by assessing patients for improvement in symptoms and ocular oil gland function after 4 weeks of a daily thermal therapy application.

Full description

This study will be a non-randomized, open label study of subjects with documented MGD. All subjects will be sent home with a wireless, portable thermal therapy device and examined pre and post treatment period. Subjects will be asked to use the device at bedtime for 5 minutes daily for 4 weeks. After treatment subjects will be re-examined and measured for clinical and symptomatic change in their MGD as well as changes to their sleep quality and anxiety index. Subjects will also be followed after treatment has been completed.

Enrollment

20 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Clinical diagnosis of MGD
  • Minimum age 18 years

Exclusion criteria

  • History of ocular disease, trauma, surgery (other than refractive), orbital cancer
  • 3 month history of ocular infection and/or ocular inflammation not associated with dry eye
  • 3 month history of any active physician administered or prescription dry eye treatment
  • Pregnant, potentially pregnant or nursing

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

20 participants in 1 patient group

Thermal Therapy
Experimental group
Description:
Heat application using at home thermal therapy device
Treatment:
Device: Thermal therapy device

Trial contacts and locations

0

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Central trial contact

Sharmin Habib, OD

Data sourced from clinicaltrials.gov

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