Single Lipiflow Treatment to Reduce Pharmacologic Burden in DED

NCT ID: NCT06542276

Last Updated: 2024-08-12

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-01
• Study Completion Date: 2024-09-01

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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Lipiflow treatment results

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

Group Type: OTHER

Thermal Vectored Pulsation

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

Lipiflow

Eligibility Criteria

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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Johnson & Johnson

INDUSTRY

Sponsor Role: collaborator

Dunes Eye Consultants

OTHER

Sponsor Role: lead

Responsible Party

Steve Ferguson

Lead Optometrist/ Director of Dry Eye Treatment Center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Dunes Eye Consultants

Dakota Dunes, South Dakota, United States

Countries

United States

Other Identifiers

DunesEye

Identifier Type: -

Identifier Source: org_study_id