Treatment Regimens in Meibomian Gland Dysfunction

Completed · Phase 4

Conditions studied: Dry Eye Syndromes

In brief

This study seeks to explore the relevance of inflammation in dry eye patients with MGD and compare the efficacy of LipiFlow treatment followed by lid hygiene and lubricant treatment with Systane Ultra or LipiFlow treatment followed by lid hygiene and lifitegrast treatment in patients with meibomian gland dysfunction.

Key facts

Study ID

NCT05594745

Run by

Tauber Eye Center

People needed

60

Starts

2021-03-02

Expected to finish

2023-01-21

Last updated by the study team

2023-04-12

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adult patients aged 18 or older, of any sex and any race. 2. Clinical diagnosis of MGD, defined as:
• complaints of burning, stinging or dryness > 40 on scale of 0-100.
• thickened secretions or occlusion of > 4 of eight assessed glands of the central lower eyelid.
• clinically evident redness of the eyelid margin > 1+ on a scale of 0-4. 4. Willing to comply with the protocol instructions. 5. Has read (or has had read to), understood, and signed an Informed Consent.

You may not qualify if…

• 1. Active ocular infection or ocular inflammatory disease. 2. Anterior basement membrane dystrophy or history of recurrent erosion syndrome.
• History of severe / serious ocular pathology or other medical condition that could result in an inability to safely complete the study. 4. Ocular surgery, LipiFlow or iLux or IPL or MG duct probing within past 6 months.
• Participation by the patient in any other investigational study within the past 30 days.
• Unlikely to comply with protocol instructions for any reason (confusion, substance abuse, etc.).
• The Principal Investigator or the Medical Monitor reserves the right to declare a patient ineligible based on medical evidence that indicates the patient is unsuitable for the study.

Where it is running

• joseph Tauber — Kansas City, Missouri, United States

Full record on ClinicalTrials.gov

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