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Treatment Regimens in Meibomian Gland Dysfunction

Primary Purpose

Dry Eye Syndromes

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Lifitegrast Ophthalmic
Systane Free
Lipiflow
Sponsored by
Tauber Eye Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dry Eye Syndromes

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • joseph Tauber

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Xiidra

Systane

Arm Description

one drop BID for 9 months

One drop QID for 9 months

Outcomes

Primary Outcome Measures

eye dryness score
visual analog scale from 0 to 100, higher is worse

Secondary Outcome Measures

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

Full Information

First Posted
October 20, 2022
Last Updated
April 11, 2023
Sponsor
Tauber Eye Center
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1. Study Identification

Unique Protocol Identification Number
NCT05594745
Brief Title
Treatment Regimens in Meibomian Gland Dysfunction
Official Title
Comparative Efficacy of Different Treatment Regimens in Patients With Dry Eye Disease and Meibomian Gland Dysfunction
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
March 2, 2021 (Actual)
Primary Completion Date
January 21, 2023 (Actual)
Study Completion Date
January 21, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tauber Eye Center

4. Oversight

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
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Syndromes

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Multiple group, single unmasked randomized trial
Masking
Investigator
Masking Description
Randomized
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Xiidra
Arm Type
Active Comparator
Arm Description
one drop BID for 9 months
Arm Title
Systane
Arm Type
Active Comparator
Arm Description
One drop QID for 9 months
Intervention Type
Drug
Intervention Name(s)
Lifitegrast Ophthalmic
Other Intervention Name(s)
Xiidra
Intervention Description
eyedrop
Intervention Type
Drug
Intervention Name(s)
Systane Free
Intervention Description
eyedrop
Intervention Type
Device
Intervention Name(s)
Lipiflow
Other Intervention Name(s)
thermal pulsation
Intervention Description
thermal pulsation
Primary Outcome Measure Information:
Title
eye dryness score
Description
visual analog scale from 0 to 100, higher is worse
Time Frame
9 months
Secondary Outcome Measure Information:
Title
corneal flurescein staining
Description
NEI corneal staining scale scored from 0 to 4, higher is worse
Time Frame
9 months
Title
ocular discomfort score
Description
visual analog scale from 0 to 100, higher is worse
Time Frame
9 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 1. 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. - 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.
Facility Information:
Facility Name
joseph Tauber
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
22378109
Citation
Lemp MA, Crews LA, Bron AJ, Foulks GN, Sullivan BD. Distribution of aqueous-deficient and evaporative dry eye in a clinic-based patient cohort: a retrospective study. Cornea. 2012 May;31(5):472-8. doi: 10.1097/ICO.0b013e318225415a.
Results Reference
background
PubMed Identifier
15502475
Citation
Nichols KK, Nichols JJ, Mitchell GL. The lack of association between signs and symptoms in patients with dry eye disease. Cornea. 2004 Nov;23(8):762-70. doi: 10.1097/01.ico.0000133997.07144.9e.
Results Reference
background
PubMed Identifier
21450914
Citation
Nelson JD, Shimazaki J, Benitez-del-Castillo JM, Craig JP, McCulley JP, Den S, Foulks GN. The international workshop on meibomian gland dysfunction: report of the definition and classification subcommittee. Invest Ophthalmol Vis Sci. 2011 Mar 30;52(4):1930-7. doi: 10.1167/iovs.10-6997b. Print 2011 Mar. No abstract available.
Results Reference
background
PubMed Identifier
31030780
Citation
Starr CE, Gupta PK, Farid M, Beckman KA, Chan CC, Yeu E, Gomes JAP, Ayers BD, Berdahl JP, Holland EJ, Kim T, Mah FS; ASCRS Cornea Clinical Committee. An algorithm for the preoperative diagnosis and treatment of ocular surface disorders. J Cataract Refract Surg. 2019 May;45(5):669-684. doi: 10.1016/j.jcrs.2019.03.023.
Results Reference
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Treatment Regimens in Meibomian Gland Dysfunction

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