Clinical trial NCT06326931: Thermal Pulsation Versus Warm Compress Treatment for Meibomian Gland Dysfunction
Official title: A Prospective, Randomized Comparison of Thermal Pulsation Versus Warm Compress Treatment for Signs and Symptoms of Meibomian Gland Dysfunction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Meibomian Gland Dysfunction
Lead sponsor: Jacksoneye
Sponsor class: OTHER
First posted: 2024-03-22
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, randomized, controlled clinical trial
Primary purpose: TREATMENT

Brief summary: This study aimed to assess the treatment outcome differences between a single, in-office bilateral treatment with the thermal pulsation system and twice-daily, 10-minute applications of the warm compress mask at home for 8 weeks.

Detailed description: This prospective, single-center, single-masked, randomized, controlled clinical trial compared the Systane iLux handheld thermal pulsation system with a warm compress mask (Bruder Moist Heat Eye Compress, Bruder Healthcare, Alpharetta, GA, USA) for the treatment of meibomian gland dysfunction (MGD).

Subjects aged 18 or older were randomized 1:1 to either a single in-office thermal pulsation treatment or twice-daily use of the warm compress mask, with both eyes undergoing the same treatment. Enrollment criteria included Ocular Surface Disease Index (OSDI) score \>23, total meibomian gland secretion (MGS) score \< or =12 in the lower lid of each eye, and tear break-up time (TBUT) \< 10 seconds. TBUT, MGS, and corneal staining scores were evaluated at baseline, 2 weeks, and 8 weeks. Symptoms were evaluated using the OSDI questionnaire at baseline, 2 weeks, and 8 weeks.

Eligibility criteria: Inclusion Criteria:

* history of self-reported dry eye symptoms for 3 months prior to study enrollment
* baseline OSDI score of 23 or greater (
* MGS score of 12 ior less in the lower eyelid of each eye
* TBUT \<10 seconds
* willing and able to abstain from using any new ocular lubricants

Exclusion Criteria:

* diagnosis of thyroid dysfunction or rheumatoid arthritis
* history of laser-assisted in situ keratomileusis (LASIK); any other ocular surgery within the previous 12 months
* abnormal lid anatomy or active lid lesions
* use of topical glaucoma medications, medications affecting the central nervous system, or hormonal drugs within the previous month
* active ocular infection
* pterygium
* planned use of contact lenses, topical antibiotics, steroids, or immunomodulating drops
* CDVA worse than 0.2 logMAR

Primary outcomes:
measure: Change in MGS score for the worse eye
timeFrame: baseline to Week 8
Secondary outcomes:
measure: Change in MGS score for the worse eye
timeFrame: baseline to Week 2
measure: Change in OSDI score
timeFrame: Baseline to Week 2
measure: Change in OSDI score
timeFrame: Baseline to Week 8
measure: Incidence of adverse events
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Lake Villa
country: United States
facility: Jacksoneye
state: Illinois
Study officials:
affiliation: Jacksoneye
name: Melissa Bollinger, OD, FAAO
role: PRINCIPAL_INVESTIGATOR
References: