NCT06326931

Thermal Pulsation Versus Warm Compress Treatment for Meibomian Gland Dysfunction

A Prospective, Randomized Comparison of Thermal Pulsation Versus Warm Compress Treatment for Signs and Symptoms of Meibomian Gland Dysfunction

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 68 (actual)
• Sponsor: Jacksoneye · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Meibomian Gland Dysfunction

Interventions

Type	Name	Description
DEVICE	thermal pulsation	Single, in-office bilateral treatment with Systane iLux thermal pulsation
OTHER	warm compress	Twice daily, 10-minute at-home treatment with Bruder warm compress mask for 8 weeks

Timeline

• Start date: 2022-06-24
• Primary completion: 2023-06-22
• Completion: 2023-06-22
• First posted: 2024-03-22
• Last updated: 2024-03-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study