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

Dry Eye Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03291704
• Other study ID #: Meibomian Gland Dysfunction
• Status: Not yet recruiting
• Phase: N/A
• First received: September 12, 2017
• Last updated: March 15, 2018
• Start date: March 2018
• Est. completion date: July 2018

Study information

• Verified date: March 2018
• Source: UMay Care Inc.
• Contact: Sharmin Habib, OD
• Phone: 5875017422
• Email: sharmin[@]umay.care
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: July 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dry Eye Disease
• Dry Eye Syndromes
• Eye Diseases
• Keratoconjunctivitis Sicca
• Meibomian Gland Dysfunction

Intervention

Device:
• Thermal therapy device
Thermal therapy of blocked Meibomian glands

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
UMay Care Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Non-Invasive Tear Film Break Up Time (NITFBUT) in Seconds	Ocular surface analysis of tear film evaporation	Before and after 4 weeks of daily treatment
Secondary	Change in Ocular Surface Disease Index (OSDI) Score	Standardized symptom questionnaire	Before and after 4 weeks of daily treatment
Secondary	Meibum Expressibility	Grade of Meibum oil expressibility from Meibomian Gland	Before and after 4 weeks of daily treatment
Secondary	Sleep Quality	Pittsburg Sleep Quality Index (PSQI)	Before and after 4 weeks of daily treatment
Secondary	State Trait and Anxiety	State-Trait Anxiety Index (STAI)	Before and after 4 weeks of daily treatment