Clinical trial NCT06542276: Single Lipiflow Treatment to Reduce Pharmacologic Burden in DED
Official title: Single Vectored Thermal Pulsation Treatment in Patients Using Topical Immunomodulators in the Management of Dry Eye Disease
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: MGD-Meibomian Gland Dysfunction
Lead sponsor: Dunes Eye Consultants
Sponsor class: OTHER
Collaborators: name: Johnson & Johnson
First posted: 2024-08-07
Enrollment: 30
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This study, known as the REDUCE study, was a prospective, non-randomized, single-site, non- comparative study that evaluated the efficacy of a single vectored thermal pulsation (VTP) treatment in patients who were currently being treated with topical immunomodulator agents. This study was conducted in compliance with the Declaration of Helsinski and was reviewed and approved by the WCG institutional review board (IRB). The study is registered in clinictrials.gov. All participants provided written informed consent.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Number of Subjects discontinuing Topical Immunomodulator use
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Dakota Dunes
country: United States
facility: Dunes Eye Consultants
state: South Dakota
Study officials:
References: