Treatment Regimens in Meibomian Gland Dysfunction

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-02

Study Completion Date

2023-01-21

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Dry Eye Syndromes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Multiple group, single unmasked randomized trial

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Randomized

Study Groups

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Xiidra

one drop BID for 9 months

Group Type ACTIVE_COMPARATOR

Lifitegrast Ophthalmic

Intervention Type DRUG

eyedrop

Lipiflow

Intervention Type DEVICE

thermal pulsation

Systane

One drop QID for 9 months

Group Type ACTIVE_COMPARATOR

Systane Free

Intervention Type DRUG

eyedrop

Lipiflow

Intervention Type DEVICE

thermal pulsation

Interventions

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Lifitegrast Ophthalmic

eyedrop

Intervention Type DRUG

Systane Free

eyedrop

Intervention Type DRUG

Lipiflow

thermal pulsation

Intervention Type DEVICE

Other Intervention Names

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Xiidra thermal pulsation

Eligibility Criteria

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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.

\-

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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No