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

Sponsor

UMay Care Inc. (Industry)

Overall Status

Unknown status

CT.gov ID

NCT03291704

Collaborator

(none)

Enrollment

Arm

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Meibomian Gland Dysfunction Dry Eye Disease	Device: Thermal therapy device	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

PILOT STUDY: The Effect of Thermal Therapy Using a Rechargeable, Wireless Device on Meibomian Gland Dysfunction

Anticipated Study Start Date :

Mar 1, 2018

Anticipated Primary Completion Date :

Jun 1, 2018

Anticipated Study Completion Date :

Jul 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Thermal Therapy Heat application using at home thermal therapy device	Device: Thermal therapy device Thermal therapy of blocked Meibomian glands Other Names: umayREST

Arm

Intervention/Treatment

Experimental: Thermal Therapy

Heat application using at home thermal therapy device

Device: Thermal therapy device

Thermal therapy of blocked Meibomian glands

Other Names:

umayREST

Outcome Measures

Primary Outcome Measures

Change in Non-Invasive Tear Film Break Up Time (NITFBUT) in Seconds [Before and after 4 weeks of daily treatment]
Ocular surface analysis of tear film evaporation

Secondary Outcome Measures

Change in Ocular Surface Disease Index (OSDI) Score [Before and after 4 weeks of daily treatment]
Standardized symptom questionnaire
Meibum Expressibility [Before and after 4 weeks of daily treatment]
Grade of Meibum oil expressibility from Meibomian Gland
Sleep Quality [Before and after 4 weeks of daily treatment]
Pittsburg Sleep Quality Index (PSQI)
State Trait and Anxiety [Before and after 4 weeks of daily treatment]
State-Trait Anxiety Index (STAI)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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