Vectored Thermal Pulsation, Intense Pulsed Light, and Eyelid Warm Compress Therapies for MGD

NCT05577910 | Completed FDA Device

• 1 other identifier: HMRF-08190266
• Study Type: interventional
• Target: 374
• Locations: 1 country
• Sites: 4

Brief Summary

Meibomian gland dysfunction (MGD), closely associated with Dry Eye Disease (DED), is a chronic condition where terminal ducts are obstructed and/or glandular secretion changes. The efficacy of traditional treatment options, e.g. eyelid warm compress therapy (EW) is limited with low compliance. This study aims to (1)compare the efficacy and safety of two emerging alternatives- vectored thermal pulsation(VTP) or intense pulsed light and meibomian gland expression(IPL + MGX) with EW therapy; (2)identify factors predicting outcome. This is a prospective, randomized, assessor-masked, active-controlled clinical study. 360 participants (360 study eyes) with mild-to-moderate MGD will be randomized by minimization into three arms equally, receiving either VTP by TearScience-LipiFlow® Thermal Pulsation System (month 0), IPL by Lumenis®️M22 with MGX (month 0, 1, 2, 3) or EW (twice daily). Lubricating eye drops (3% Hypromellose) will be provided for all subjects throughout the study period(15 months). Tear film breakup time will be assessed as primary outcome at month 6, 15. Serial measurements of MG, tear-film, DED-related parameters, intraocular pressure, compliance to EW, factors associated with outcomes and treatment-related complications will be conducted at baseline and each follow-up visit by masked observers at baseline and eight follow-up evaluation (month 0, 1, 2, 3, 4, 6, 9, 12, 15).

Conditions

Meibomian Gland Dysfunction

Keywords

Meibomian Gland Dysfunction; Dry Eye Disease; Vectored Thermal Pulsation therapy; Intense Pulsed Light therapy

Outcome Measures

Primary Outcomes (2)

• Change from baseline Tear film breakup time (TFBUT) at 6 months

  Sodium fluorescein will be instilled in both eyes of the subject. A follow-up investigator will do the examination by slit lamp. Tear film breakup time (TFBUT) is the time to initial breakup of the tear film after a blink is measured three times and taken average.

  6 months

• Change from baseline Tear film breakup time (TFBUT) at 15 months

  Sodium fluorescein will be instilled in both eyes of the subject. A follow-up investigator will do the examination by slit lamp. Tear film breakup time (TFBUT) is the time to initial breakup of the tear film after a blink is measured three times and taken average.

  15 months

Secondary Outcomes (21)

• Change in Ocular Surface Disease Index (OSDI)

  15 months

• Change in Standard Patient Evaluation of Eye Dryness (SPEED)

  15 months

• Change in symptom Assessment iN Dry Eye (SANDE)

  15 months

• Change in ocular comfort index (OCI)

  15 months

• Change in dry eye questionnaire (DEQ-5)

  15 months

Other Outcomes (15)

• Change in visual acuity

  15 months

• Levels in procedure-related pain (VAS)

  3 months

• Change in intraocular pressure

  15 months

Study Arms (3)

Group A

EXPERIMENTAL

One session VTP at month 0.

Device: Vectored thermal pulsation (VTP) therapy; Drug: Topical eye drops (Hypromellose, 3mg/ml)

Group B

EXPERIMENTAL

Four sessions IPL+MGX at month 0,1,2,3.

Device: Intense pulsed light with meibomian gland expression (IPL+MGX) therapy; Drug: Topical eye drops (Hypromellose, 3mg/ml)

Group C

ACTIVE COMPARATOR

Twice daily EW for 15 months.

Behavioral: Eyelid Warm Compress Therapy (EW); Drug: Topical eye drops (Hypromellose, 3mg/ml)

Interventions

Vectored thermal pulsation (VTP) therapy DEVICE

VTP purchased from TearScience®️ is an automated thermal pulsation system that is designed to heat and simultaneously evacuate the meibomian gland contents. It is performed by the unmasked treating investigators as described by the equipment manufacturer. In brief, one to two drops of topical anesthesia are applied prior to the bilateral application of the activators. The inner portion of the activator applies a constant temperature of 42.5°C to the tarsal conjunctiva of upper and lower eyelids. Simultaneously, the outer portion of the activator applies directional, pulsatile pressure to the external eyelid surfaces (maximum 6 psi) for the 12-minute treatment cycle. Participants will receive one session of VTP treatment only (month 0).

Group A

Topical eye drops (Hypromellose, 3mg/ml) DRUG

All patients will be given one single topical lubricant (Hypromellose, 3mg/ml) to be used as frequently as needed from recruitment to study exit (total 16 months).

Group A; Group B; Group C

Intense pulsed light with meibomian gland expression (IPL+MGX) therapy DEVICE

IPL is delivered using the proprietary "dry eye mode" setting of the Lumenis®️ M22TM system per the Toyos protocol. Pulse intensity (11-14 J/cm2) is inversely related to the Fitzpatrick skin phototype of each participant and will be used for the same patient throughout the study. IPL will be delivered to four overlapping zones inferior to each eye and a fifth pulse applied temporally adjacent to the lateral canthus four times. Both eyelids are closed and sealed with IPL-Aid disposable eye shields. MGX is immediately performed on both upper and lower eyelids of each eye and pain will be minimized by topical anesthetic. Participants will receive four-session IPL and MGX treatment (month 0, 1, 2 ,3).

Group B

Eyelid Warm Compress Therapy (EW) BEHAVIORAL

EW using warm wet towel to each eye is performed twice daily for 10 mins. A treatment diary will be given for patients randomized to EW for daily recording which will be reviewed and recorded by the unmasked study coordinator at each study visit.

Group C

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥18 years of age with no upper age limit;
• Agree to attend follow-up visits and comply to treatment regimen;
• Symptomatic dry eye TFBUT (average of 3 times) ≤ 5 seconds and OSDI ≥ 13;
• Mild to moderate (level 3-4) MGD on at least one eye;
• Fitzpatrick skin type 1-4.

You may not qualify if:

• Contact lens wear 3 months before or during the study period;
• Use of topical (including anti-glaucomatous, cyclosporin, antibiotics) or systemic medication known to affect (worsen or improve) MGD 3 months before or during the study period;
• Major systemic (e.g. Sjogren's syndrome), dermatologic (e.g. Rosacea) known to affect MGD or ocular conditions (including thyroid eye disease, recurrent conjunctivitis, ocular allergies);
• Ocular procedures (excluding uncomplicated cataract operation) 3 months before and any ocular procedure during the study period;
• History of vision correction surgery or plan to undergo the procedure during the study period;
• Dermatological treatment (including chemical peeling, laser, IPL or energy device in the periocular and facial region) 6 months before or during the study period;
• Contraindications to IPL therapy (including recent sun-burn, photosensitivity, active or pigmented skin lesions, cancer, implants, tattoos, semi-permanent makeup in the periocular area);
• Contraindications to VTP therapy (ocular surgery, ocular injury, ocular herpes of eye or eyelid, and ocular inflammation 3 months before the study; active ocular infection, etc.)
• Women who are pregnant, nursing, planning pregnancy, or of childbearing potential not using a reliable method of contraception.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (4)

Hong Kong Eye Hospital

Kowloon, Hong Kong, Hong Kong

Location

The Chinese University of Hong Kong Eye Centre (CUHKEC)

Kowloon, 000000, Hong Kong

Location

The CUHK Medical Centre (CUHKMC)

Shatin, 000 000, Hong Kong

Location

Prince of Wales Hospital

Shatin, 000000, Hong Kong

Location

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MeSH Terms

Conditions

Meibomian Gland Dysfunction; Dry Eye Syndromes

Interventions

Therapeutics; Ophthalmic Solutions; Hypromellose Derivatives

Condition Hierarchy (Ancestors)

Eyelid Diseases; Eye Diseases; Lacrimal Apparatus Diseases

Intervention Hierarchy (Ancestors)

Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals; Cellulose; Glucans; Biopolymers; Polymers; Macromolecular Substances; Polysaccharides; Carbohydrates; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Kelvin KL Chong, MBChB

  The Department of Ophthalmology & Visual Sciences, the Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Unmasked trial coordinators will ensure masking by reminding and accompanying each patient before and during visits. Treatment related complications will be evaluated by all participants in a standard datasheet regardless of group assignment. Follow-up investigators will be asked if they know each participant's group assignment at each visit and why.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Department of Ophthalmology and Visual Sciences, CUHK

Model Details: This is a prospective, randomized, assessor-masked, 3-arm (1:1:1), active-controlled trial of 360 subjects with meibomian gland dysfunction contributing one study eye. For subjects with both eyes eligible, the eye with the most meibomian gland dropout (meiboscore), fewest expressible meibomian glands, thinnest lipid layer, or lowest TFBUT values (in this order) will be selected as the study eye. Enrolled patients will be randomized into one of the following groups, 1 month after recruitment during the 15-month study period receiving bilateral treatment of: Group A: 1-session VTP at month 0 Group B: 4-session IPL+MGX at month 0,1,2,3 Group C: twice daily EW for 15 months Topical lubricating eye drops (Hypromellose, 3mg/ml) will be the monotherapy for all subjects.

Study Record Dates

• First Submitted: September 27, 2022
• First Posted: October 13, 2022
• Study Start: October 8, 2022
• Primary Completion: December 1, 2024
• Study Completion: January 26, 2025
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

HK (4)