Single Lipiflow Treatment to Reduce Pharmacologic Burden in DED (Reduce)

Single Vectored Thermal Pulsation Treatment in Patients Using Topical Immunomodulators in the Management of Dry Eye Disease

Purpose: To evaluate the efficacy of vectored thermal pulsation treatment in subjects with a history of dry eye disease currently using a topical immunomodulator medication.

Study Overview

• Status: Enrolling by invitation
• Conditions: MGD-Meibomian Gland Dysfunction
• Intervention / Treatment: Device: Thermal Vectored Pulsation

Detailed Description

Prospective, non-randomized, interventional study. Subjects with bilateral use of a topical immunomodulator drop and a history of dry eye disease were recruited to participate. All subjects underwent a vectored thermal pulsation treatment (LipiFlow). Patients were seen at baseline in a visit immediately prior to treatment and at months 1 and 3 following treatment. Data collected included tear osmolarity, tear break up time (TBUT), tear meniscus height (TMH), meibomian gland function and patient-reported symptoms using the ocular surface disease index (OSDI) questionnaire. Following the 3-month visit, patients were given the option to resume topical immunomodulator therapy.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • South Dakota
    • Dakota Dunes, South Dakota, United States, 57049
      • Dunes Eye Consultants

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• No prior history of meibomian gland treatment procedures LipiFlow, TearCare, or I-Lux
• lifitegrast or cyclosporine eye drops daily for a period of at least one year but not exceeding five years
• Meibograpy documneted retention of at least 50% of meibomian glands.

Exclusion Criteria:

• evidence of meibomian gland dropout exceeding 50%
• ocular rosacea,
• ocular surgery within the preceding three months
• prior in-office thermal meibomian gland treatment
• ocular trauma within preceding three months
• ocular herpetic infection
• chronic or recurrent inflammation
• eyelid abnormalities affecting lid function ocular surface abnormalities compromising corneal integrity (eg, epithelial basement membrane dystrophy, corneal burn)
• pregnant

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Lipiflow treatment results; A single thermal vectored pulsation treatment of MGD with 3 month results review of treatment to evaluate objective and subjective response.

Device: Thermal Vectored Pulsation; The LipiFlow® (Johnson & Johnson Vision, USA) Thermal Pulsation System, also known as vectored thermal pulsation, is a treatment that applies localized heat and pressure to the meibomian glands lining the eyelids. The device consists of a console connected to single-use, sterile devices applied to each eye known as activators. The activator includes an eye warmer with a large lens that gently sits on the conjunctiva of each eye. The activator cups the upper and lower eyelid and applies regulated, outward heat to the surface of the palpebral conjunctiva with an air bladder that intermittently provides directional, controlled massage of the eyelids to promote expression of the liquified contents.; Other Names: Lipiflow

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Subjects discontinuing Topical Immunomodulator use	OSDI, TBUT, Tear Osmolarity, Meibomian gland expression quantity, TM	3 months

Collaborators and Investigators

• Sponsor: Dunes Eye Consultants
• Collaborators: Johnson & Johnson

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2023
• Primary Completion (Actual): February 28, 2024
• Study Completion (Estimated): September 1, 2024

Study Registration Dates

• First Submitted: July 21, 2024
• First Submitted That Met QC Criteria: August 4, 2024
• First Posted (Actual): August 7, 2024

Study Record Updates

• Last Update Posted (Actual): August 12, 2024
• Last Update Submitted That Met QC Criteria: August 8, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Eyelid Diseases; Meibomian Gland Dysfunction
• Other Study ID Numbers: DunesEye

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Abstract
• IPD Sharing Time Frame: 12months
• IPD Sharing Access Criteria: website
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes