NCT06542276

Single Lipiflow Treatment to Reduce Pharmacologic Burden in DED

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

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Dunes Eye Consultants · Academic / Other
• Sex: All
• Age: 25 Years – 65 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• MGD-Meibomian Gland Dysfunction

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-09-01
• Primary completion: 2024-02-28
• Completion: 2024-09-01
• First posted: 2024-08-07
• Last updated: 2024-08-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study