Treatment Regimens in Meibomian Gland Dysfunction

Phase 4

Completed

• Conditions: Dry Eye Syndromes
• Interventions: Drug: Lifitegrast Ophthalmic; Drug: Systane Free; Device: Lipiflow

• Registration Number: NCT05594745
• Lead Sponsor: Tauber Eye Center

Brief 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.

Detailed Description

The role of inflammation as a central mechanism of pathophysiology in dry eye disease has been well documented, including both clinical and basic science studies. It has been estimated that 50-75% of patients complaining of dry eyes have meibomian gland dysfunction (MGD). As defined by TFOS DEWs II MGD is a chronic, diffuse abnormality of the meibomian glands, commonly characterized by terminal duct obstruction and/or qualitative/quantitative changes in the glandular secretion. This may result in the alteration of the tear film, symptoms of eye irritation, clinically apparent inflammation, and ocular surface disease. It has been estimated that 86% of patients complaining of dry eye disease demonstrate meibomian gland dysfunction. The role of ocular surface inflammation vs. the role of obstructive meibomian gland disease is less well understood.

The symptoms of MGD (evaporative dry eye) may be difficult to differentiate from those of dry eye syndrome (aqueous deficient dry eye (ADDE)), though MGD patients tend to report more burning and stinging than they report complaints of grittiness, sandiness or foreign body sensation in the eyes. However, there is a significant lack of association between signs and symptoms in patients with dry eye disease, which makes it extremely difficult to sort out which patients would benefit from which treatment options. Given the high prevalence of dry eye in the general population any attempt to segregate patients into appropriate treatment types is important.

Traditional treatment options for MGD include the use of artificial lubricants (some lipid-containing such as Systane Ultra), warm lid compresses using cloths or heat pads of various materials, systemic tetracyclines and episodic treatment with topical antibiotics or antibiotic/steroid combinations. Eyelid thermal pulsation procedures (e.g. LipiFlow) have helped many patients. Only one published study supports the benefit of anti-inflammatory treatment (lifitegrast) in patients with MGD. 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.

Study Timeline

• Study Start: 2021-03-02
• Study First Submitted: 2022-10-20
• Study First Submitted QC: 2022-10-25
• Study First Posted: 2022-10-26
• Primary Completion: 2023-01-21
• Study Completion: 2023-01-21
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-11
• Last Update Posted: 2023-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

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

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

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

4. 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.

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.

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

     5. 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Xiidra	Lifitegrast Ophthalmic	one drop BID for 9 months
Xiidra	Lipiflow	one drop BID for 9 months
Systane	Systane Free	One drop QID for 9 months
Systane	Lipiflow	One drop QID for 9 months

Primary Outcome Measures

Name	Time	Method
eye dryness score	9 months	visual analog scale from 0 to 100, higher is worse

Secondary Outcome Measures

Name	Time	Method
corneal flurescein staining	9 months	NEI corneal staining scale scored from 0 to 4, higher is worse
ocular discomfort score	9 months	visual analog scale from 0 to 100, higher is worse

Trial Locations

Locations (1)

joseph Tauber; 🇺🇸 Kansas City, Missouri, United States