Single Lipiflow Treatment to Reduce Pharmacologic Burden in DED

Conditions

• MGD-Meibomian Gland Dysfunction

Eligibility Criteria

Sex

ALL

Age

25 Years - 65 Years

Healthy Volunteers

Accepted

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.

Study Details

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.

Key Dates

Start date

Sep 1, 2023

Status verified

Aug 2024

Primary completion

Feb 28, 2024

Completion

Sep 1, 2024

Study Design

Enrollment

30 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• 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.

Primary Outcome Measure

Number of Subjects discontinuing Topical Immunomodulator use [ Time Frame: 3 months ]

Locations (1)

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