Treatment Regimens in Meibomian Gland Dysfunction

• Status: Active, not recruiting
• Trial end date: 2022-10-21
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tauber Eye Center
• Treatments: Lifitegrast

Criteria

Inclusion Criteria:

1. Adult patients aged 18 or older, of any sex and any race. 2. Clinical diagnosis of MGD, defined as:

1. complaints of burning, stinging or dryness > 40 on scale of 0-100.

2. thickened secretions or occlusion of > 4 of eight assessed glands of the central lower eyelid.

3. 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.

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Exclusion Criteria:

• 1. Active ocular infection or ocular inflammatory disease. 2. Anterior basement membrane dystrophy or history of recurrent erosion syndrome.

3. 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.

5. Participation by the patient in any other investigational study within the past 30 days.

6. 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.