Meibomian Gland Dysfunction Treatment

Not Applicable

Completed

• Conditions: Dry Eye; Meibomian Gland Dysfunction
• Interventions: Device: LipiFlow; Device: Light Based (Sham) Treatment

• Registration Number: NCT04229888
• Lead Sponsor: Indiana University

Brief Summary

The purpose of this study is to evaluate the effectiveness of treatments for Meibomian Gland Dysfunction.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2020-01-13
• Study First Submitted QC: 2020-01-13
• Study First Posted: 2020-01-18
• Study Start: 2020-02-26
• Primary Completion: 2021-03-25
• Study Completion: 2021-03-25
• Results First Submitted: 2022-01-20
• Status Verified: 2022-03
• Results First Submitted QC: 2022-03-02
• Last Update Submitted: 2022-03-02
• Results First Posted: 2022-03-29
• Last Update Posted: 2022-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

• evidence of meibomian gland obstruction in both eyes
• dry eye symptoms per DEQ-5

Read More

Exclusion Criteria

• active ocular infection
• previous LipiFlow treatment
• beginning new oral or other systemic medications within prior 3 months
• beginning new or changing dosages of ocular medications within prior 3 months
• previous ocular surgery, trauma, herpes, recurrent inflammation, punctal plugs in prior 3 months
• habitual contact lens wear in prior 3 months
• women who are pregnant or nursing

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Subject Treatment	LipiFlow	All subjects will receive light based (sham) treatment, then all subjects will receive LipiFlow treatment.
Subject Treatment	Light Based (Sham) Treatment	All subjects will receive light based (sham) treatment, then all subjects will receive LipiFlow treatment.

Primary Outcome Measures

Name	Time	Method
Dry Eye Questionnaire 5 (DEQ-5) Score	2 weeks	DEQ5 total score ranges from 0-22 with the higher scores indicating increased dry eye.

Secondary Outcome Measures

Name	Time	Method
Tear Break-Up Time (TBUT)	2 weeks	Tear break-up time (defined as the time required for dry spots to appear on the surface of the eye after blinking) was assessed by the examiner using a slit lamp and fluorescein strips. Fluorescein was instilled onto the patient's eye, after which the patient blinked three times, then kept the eye open. Immediately thereafter, the examiner used a stopwatch to record the time between the last blink and the first appearance of a dark spot on the cornea (formation of dry area). Three consecutive measurements were taken and averaged for actual TBUT. A positive change value represents a lengthening in the tear break-up time and greater comfort.
Meibomian Gland Score	2 weeks	Meibomian glands evaluated on the lower eyelid using meibomian gland evaluator. 5 glands in 3 regions (nasal, central, temporal) evaluated and scored from 0 to 4 for a max score of 60 in each eye. (MGS scale 0 = clear, 1 = cloudy, 2 = granular, 3 = pastelike, 4 = obstruction)

Trial Locations

Locations (1)

Indiana University School of Optometry; 🇺🇸 Bloomington, Indiana, United States