NCT05594745

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Mar 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 2, 2021

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

October 20, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 26, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 21, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 21, 2023

Completed
Last Updated

April 12, 2023

Status Verified

April 1, 2023

Enrollment Period

1.9 years

First QC Date

October 20, 2022

Last Update Submit

April 11, 2023

Conditions

Dry Eye Syndromes

Outcome Measures

Primary Outcomes (1)

  • eye dryness score

    visual analog scale from 0 to 100, higher is worse

    9 months

Secondary Outcomes (2)

  • corneal flurescein staining

    9 months

  • ocular discomfort score

    9 months

Study Arms (2)

Xiidra

ACTIVE COMPARATOR

one drop BID for 9 months

Drug: Lifitegrast OphthalmicDevice: Lipiflow

Systane

ACTIVE COMPARATOR

One drop QID for 9 months

Drug: Systane FreeDevice: Lipiflow

Interventions

Lifitegrast OphthalmicDRUG

eyedrop

Also known as: Xiidra
Xiidra
Systane FreeDRUG

eyedrop

Systane
LipiflowDEVICE

thermal pulsation

Also known as: thermal pulsation
SystaneXiidra

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • \. 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.

You may not qualify if:

  • \. Active ocular infection or ocular inflammatory disease. 2. Anterior basement membrane dystrophy or history of recurrent erosion syndrome.
  • \. 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.
  • \. Participation by the patient in any other investigational study within the past 30 days.
  • \. 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

joseph Tauber

Kansas City, Missouri, 64111, United States

Location

Related Publications (4)

  • 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.

    PMID: 22378109BACKGROUND

  • 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.

    PMID: 15502475BACKGROUND

  • 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.

    PMID: 21450914BACKGROUND

  • 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.

    PMID: 31030780BACKGROUND

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

lifitegrast

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
Randomized
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Multiple group, single unmasked randomized trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 20, 2022

First Posted

October 26, 2022

Study Start

March 2, 2021

Primary Completion

January 21, 2023

Study Completion

January 21, 2023

Last Updated

April 12, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)