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

NCT ID: NCT03291704

Last Updated: 2018-03-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-31
• Study Completion Date: 2018-07-31

Brief Summary

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.

Detailed 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.

Conditions

Meibomian Gland Dysfunction; Dry Eye Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Thermal Therapy

Heat application using at home thermal therapy device

Group Type: EXPERIMENTAL

Thermal therapy device

Intervention Type: DEVICE

Thermal therapy of blocked Meibomian glands

Interventions

Thermal therapy device

Thermal therapy of blocked Meibomian glands

Intervention Type: DEVICE

Other Intervention Names

umayREST

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

UMay Care Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hermina Strungaru, MD

Role: PRINCIPAL_INVESTIGATOR

University of Alberta

Central Contacts

Sharmin Habib, OD

Role: CONTACT

sharmin@umay.care

5875017422

Other Identifiers

Meibomian Gland Dysfunction

Identifier Type: -

Identifier Source: org_study_id