Single Lipiflow Treatment to Reduce Pharmacologic Burden in DED

NCT06542276 | Enrolling By Invitation FDA Device

• 1 other identifier: DunesEye
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

MGD-Meibomian Gland Dysfunction

Outcome Measures

Primary Outcomes (1)

• Number of Subjects discontinuing Topical Immunomodulator use

  OSDI, TBUT, Tear Osmolarity, Meibomian gland expression quantity, TM

  3 months

Study Arms (1)

Lipiflow treatment results

OTHER

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

Interventions

Thermal Vectored Pulsation DEVICE

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.

Also known as: Lipiflow

Lipiflow treatment results

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Dunes Eye Consultants: lead
• Johnson & Johnson: collaborator

Study Sites (1)

Dunes Eye Consultants

Dakota Dunes, South Dakota, 57049, United States

Location

MeSH Terms

Conditions

Meibomian Gland Dysfunction

Condition Hierarchy (Ancestors)

Eyelid Diseases; Eye Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lead Optometrist/ Director of Dry Eye Treatment Center

Model Details: This study, known as the REDUCE study, was a prospective, non-randomized, single-site, non- comparative study that evaluated the efficacy of a single vectored thermal pulsation (VTP) treatment in patients who were currently being treated with topical immunomodulator agents. This study was conducted in compliance with the Declaration of Helsinski and was reviewed and approved by the WCG institutional review board (IRB). The study is registered in clinictrials.gov. All participants provided written informed consent.

Study Record Dates

• First Submitted: July 21, 2024
• First Posted: August 7, 2024
• Study Start: September 1, 2023
• Primary Completion: February 28, 2024
• Study Completion: September 1, 2024
• Last Updated: August 12, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: 12months
• Access Criteria: website

Locations

US (1)