Meibomian Gland Dysfunction Treatment

Dry Eye Clinical Trial

Official title:

Meibomian Gland Dysfunction Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04229888
• Other study ID #: 1908329543
• Status: Completed
• Phase: N/A
• Start date: February 26, 2020
• Est. completion date: March 25, 2021

Study information

• Verified date: March 2022
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: March 25, 2021
• Est. primary completion date: March 25, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dry Eye
• Dry Eye Syndromes
• Meibomian Gland Dysfunction

Intervention

Device:
• LipiFlow
Medical device that applies a combination of heat and pressure to the inner eyelid to remove gland obstructions and stagnant gland content
• Light Based (Sham) Treatment
A light based (sham) treatment will be used to compare effectiveness to the LipiFlow treatment.

Locations

Country	Name	City	State
United States	Indiana University School of Optometry	Bloomington	Indiana

Sponsors (2)

Lead Sponsor	Collaborator
Indiana University	Indiana University School of Optometry

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dry Eye Questionnaire 5 (DEQ-5) Score	DEQ5 total score ranges from 0-22 with the higher scores indicating increased dry eye.	2 weeks
Secondary	Meibomian Gland Score	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)	2 weeks
Secondary	Tear Break-Up Time (TBUT)	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.	2 weeks