Single Lipiflow Treatment to Reduce Pharmacologic Burden in DED

Dunes Eye Consultants

Status: Invitation-only

Conditions: MGD-Meibomian Gland Dysfunction

Treatments: Device: Thermal Vectored Pulsation

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06542276

DunesEye

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 25 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Lipiflow treatment results

Other group

Description:

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

Treatment:

Device: Thermal Vectored Pulsation