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

Not Applicable

• Conditions: Dry Eye Disease; Meibomian Gland Dysfunction
• Interventions: Device: Thermal therapy device

• Registration Number: NCT03291704
• Lead Sponsor: UMay Care Inc.

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.

Study Timeline

• Study First Submitted: 2017-09-12
• Study First Submitted QC: 2017-09-21
• Study First Posted: 2017-09-25
• Status Verified: 2018-03
• Study Start: 2018-03
• Last Update Submitted: 2018-03-15
• Last Update Posted: 2018-03-19
• Primary Completion: 2018-06
• Study Completion: 2018-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Thermal Therapy	Thermal therapy device	Heat application using at home thermal therapy device

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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)