Meibomian Gland Dysfunction Treatment

NCT04229888 | Completed Results FDA Device

• 1 other identifier: 1908329543
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Meibomian Gland Dysfunction; Dry Eye

Keywords

dry eye; meibomian gland dysfunction; lipiflow

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Meibomian Gland Score

  2 weeks

• Tear Break-Up Time (TBUT)

  2 weeks

Study Arms (1)

Subject Treatment

EXPERIMENTAL

All subjects will receive light based (sham) treatment, then all subjects will receive LipiFlow treatment.

Device: LipiFlow; Device: Light Based (Sham) Treatment

Interventions

LipiFlow DEVICE

Medical device that applies a combination of heat and pressure to the inner eyelid to remove gland obstructions and stagnant gland content

Also known as: Johnson & Johnson

Subject Treatment

Light Based (Sham) Treatment DEVICE

A light based (sham) treatment will be used to compare effectiveness to the LipiFlow treatment.

Subject Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

Indiana University School of Optometry

Bloomington, Indiana, 47405, United States

Location

MeSH Terms

Conditions

Meibomian Gland Dysfunction; Dry Eye Syndromes

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Eyelid Diseases; Eye Diseases; Lacrimal Apparatus Diseases

Results Point of Contact

• Title: Anna Tichenor
• Organization: Indiana University School of Optometry

annatich@iu.edu

812-855-0520

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Outcomes assessor blinded to visit schedule. Participants masked to invalidity of sham treatment.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Scientist

Model Details: All subjects will receive first treatment and then second treatment. The eye receiving treatment will be randomly selected. The same eye will receive both treatments.

Study Record Dates

• First Submitted: January 13, 2020
• First Posted: January 18, 2020
• Study Start: February 26, 2020
• Primary Completion: March 25, 2021
• Study Completion: March 25, 2021
• Last Updated: March 29, 2022
• Results First Posted: March 29, 2022

Record last verified: 2022-03

Locations

US (1)