Meibomian Gland Dysfunction Treatment

Not Applicable

Completed

• Conditions: Dry Eye; Meibomian Gland Dysfunction

• 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

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

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

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