Skip to main content
OpenTrials
Enrolling by Invitation

NCT Number: NCT06542276

Single Lipiflow Treatment to Reduce Pharmacologic Burden in DED

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.

Enrolling by Invitation

Interested in participating?

Request Info

Key information

Age range

25 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dunes Eye Consultants

Dakota Dunes, South Dakota, 57049, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Lipiflow

Primary outcomes

  1. Number of Subjects discontinuing Topical Immunomodulator use

    Time frame: 3 months

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

Sponsors and collaborators

Lead sponsor

Dunes Eye Consultants

Other

Collaborators

  • Johnson & Johnson

Registry information

Official study title

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

Acronym: Reduce

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 7, 2024
Registry last updated
Aug 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.