NCT03518398

Effectiveness and Safety of Intense Pulsed Light in Patients With Meibomian Gland Dysfunction

Completed Phase 3 Last updated 19 June 2019

What this trial tests

Phase 3 trial testing Intense Pulsed Light in Meibomian Gland Dysfunction (Disorder) in 114 participants. Completed in 2 April 2019.

Timeline

3 July 2018

Primary endpoint
2 April 2019

2 April 2019

Quick facts

Lead sponsor	Chulalongkorn University
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	114
Start date	3 July 2018
Primary completion	2 April 2019
Estimated completion	2 April 2019
Sites	1 location across Thailand

Drugs / interventions tested

• Intense Pulsed Light
• Standard treatment

Conditions studied

• Meibomian Gland Dysfunction (Disorder) — all drugs for Meibomian Gland Dysfunction (Disorder) →
• Dry Eye Syndromes — all drugs for Dry Eye Syndromes →

Sponsor

Chulalongkorn University

Who can join

Adults 18 to 80, any sex, with Meibomian Gland Dysfunction (Disorder) or Dry Eye Syndromes. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Meibomian gland dysfunction (MGD) is one of the most common causes of dry eye diseases. Over the past decade, several treatment options in MGD have been extensively studied including warm compression, lid hygiene, ocular lubricants, forceful expression, LipiFlow thermal pulsation system, intraductal probing, debridement scaling and intense pulsed light (IPL). IPL is a broad spectrum, non-coherent and polychromatic light source with a wavelength spectrum of 500-1200 nm. It can be filtered to allow only a range of wavelengths to be emitted. Different wavelength makes different depth of tissue to absorb a specific light energy. Intense pulsed light (IPL) has been widely used in dermatology as a therapeutic tool for removal of hypertrichosis, benign cavernous hemangioma, benign venous malformations, telangiectasia, port-wine stain and pigmented lesions. Concurrent ocular surface improvements have been observed in patients undergone IPL treatment. Very few prospective clinical trials showed that subjective dry eye symptoms decreased and some of the dry eye signs also improved. Nonetheless, there is still inconsistency in the efficacy of IPL among these studies. Biomarkers, specifically cytokines, in dry eye diseases have been studied to some extent. Moreover, the change in ocular surface inflammatory cytokines in patients with MGD after IPL treatment is unclear.

The investigators proposed a prospective randomized double-masked sham-controlled clinical trial to investigate the efficacy and safety of intense pulse light in MGD patients.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Intense pulsed light (IPL) therapy for the treatment of meibomian gland dysfunction.
   Cote S, Zhang AC, Ahmadzai V, Maleken A, et al · · 2020 · cited 47× · PMID 32182637 · DOI 10.1002/14651858.cd013559