Treatment Regimens in Meibomian Gland Dysfunction

Sponsor
Tauber Eye Center (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05594745
Collaborator
(none)
60
1
2
19.6
3.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Lifitegrast Ophthalmic
  • Drug: Systane Free
  • Device: Lipiflow
Phase 4

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 Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Multiple group, single unmasked randomized trialMultiple group, single unmasked randomized trial
Masking:
Single (Investigator)
Masking Description:
Randomized
Primary Purpose:
Treatment
Official Title:
Comparative Efficacy of Different Treatment Regimens in Patients With Dry Eye Disease and Meibomian Gland Dysfunction
Actual Study Start Date :
Mar 2, 2021
Anticipated Primary Completion Date :
Oct 21, 2022
Anticipated Study Completion Date :
Oct 21, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Xiidra

one drop BID for 9 months

Drug: Lifitegrast Ophthalmic
eyedrop
Other Names:
  • Xiidra
  • Device: Lipiflow
    thermal pulsation
    Other Names:
  • thermal pulsation
  • Active Comparator: Systane

    One drop QID for 9 months

    Drug: Systane Free
    eyedrop

    Device: Lipiflow
    thermal pulsation
    Other Names:
  • thermal pulsation
  • Outcome Measures

    Primary Outcome Measures

    1. eye dryness score [9 months]

      visual analog scale from 0 to 100, higher is worse

    Secondary Outcome Measures

    1. corneal flurescein staining [9 months]

      NEI corneal staining scale scored from 0 to 4, higher is worse

    2. ocular discomfort score [9 months]

      visual analog scale from 0 to 100, higher is worse

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.
    1. 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.

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

    3. 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 joseph Tauber Kansas City Missouri United States 64111

    Sponsors and Collaborators

    • Tauber Eye Center

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Joseph Tauber, Principal Investigator, Tauber Eye Center
    ClinicalTrials.gov Identifier:
    NCT05594745
    Other Study ID Numbers:
    • TEC_IIR2020
    First Posted:
    Oct 26, 2022
    Last Update Posted:
    Oct 26, 2022
    Last Verified:
    Oct 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 26, 2022