Therapeutic Efficacy and Safety of Non-Invasive RF Treatment in Refractory MGD

NCT06220474 | Recruiting FDA Device

• 1 other identifier: 11221686
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 2

Brief Summary

The goal of this prospective, 24-week, double-masked, randomized, sham-controlled clinical trials to compare clinical efficacy and safety of RF and MGX with MGX alone in patients with meibomian gland dysfunction-related dry eye disease. The main question it aims to answer is whether radiofrequency treatment and meibomian gland expression is more effective in improving tear breakup time, as measured using non-invasive video keratography, compared with meibomian gland expression alone, in patients with refractory meibomian gland dysfunction-related dry eye disease. Participants will be divided into two groups, one group will receive RF treatment followed with MGX and another will receive sham treatment with MGX.

Conditions

Dry Eye Syndromes; Meibomian Gland Dysfunction

Outcome Measures

Primary Outcomes (1)

• Change in non-invasive keratographic tear breakup time (NIKBUT)

  NIKBUT is measured in seconds and average of 3 consecutive readings is taken. Higher values mean better outcomes.

  From baseline to 6 months post- treatment between study groups

Secondary Outcomes (7)

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

  From baseline to 6 months post-treatment between study groups

• Percentage of subjects with normal non-invasive keratographic tear breakup time (NIKBUT)

  6 months

• Percentage of subjects with normal SPEED

  6 months

• Change in best corrected visual acuity

  from baseline to 6 months post-treatment

• Incidence of periorbital pain

  6 months

Other Outcomes (7)

• Change in cornea staining (National Eye Institute Grading System)

  from baseline to 6 months post-treatment

• Tear osmolarity

  from baseline to 6 months post-treatment

• Change in Shirmer's I test reading

  from baseline to 6 months post-treatment

Study Arms (2)

Radiofrequency treatment (RF), followed by meibomian gland expression (MGX)

EXPERIMENTAL

Before treatment, a thermage return pad will be applied to subject's skin to help prevent electrical burns. The return pad is a rubber, non-active electrode that creates a return path for radiofrequency energy back to the thermage comfort pulse technology (CPT) system. The upper and lower lid of both eyes are marked with skin marking paper (Thermage ® Skin Marking Paper TK-3.00). Coupling fluid is then applied to the external surface of the upper and lower lids of both eyes. All subjects then receive 225 applications to each eye over the upper and lower eyelids. Immediately after treatment, meibomian gland expression will be performed on both upper and lower eyelids of each eye for both eyes of all subjects using meibum expression forceps. Pain is minimized during this procedure by topical application of 0.4% oxybuprocaine hydrochloride.

Device: The Thermage FLX System

Sham treatment, followed by meibomian gland expression (MGX)

SHAM COMPARATOR

The training mode is used in the Thermage FLX, which simulates treatment without dissipation of radiofrequency energy. Immediately after treatment, meibomian gland expression will be performed on both upper and lower eyelids of each eye for both eyes of all subjects using meibum expression forceps. Pain is minimized during this procedure by topical application of 0.4% oxybuprocaine hydrochloride.

Device: Sham treatment

Interventions

The Thermage FLX System DEVICE

The Thermage FLX System is tested for its therapeutic efficacy and safety on treating refractory Meibomian Gland Dysfunction

Radiofrequency treatment (RF), followed by meibomian gland expression (MGX)

Sham treatment DEVICE

Sham treatment acts as a control to test the therapeutic efficacy and safety of The Thermage FLX System

Sham treatment, followed by meibomian gland expression (MGX)

Eligibility Criteria

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

You may qualify if:

• Age 18 or more
• Bilateral dry eye disease as confirmed by presence of both symptoms and signs 2.1 Symptoms: Abnormal result on the Standard Patient Evaluation of Eye Dryness Questionnaire (SPEED) dry eye symptom questionnaire (≥5) 2.2 Signs: Abnormal result in at least one of the following three clinical tests - tear osmolarity, NIKBUT and corneal staining for punctate epithelial erosions and,
• Bilateral moderate to severe meibomian gland dysfunction - at least Grade 1 meibum quality (cloudy appearance) and Grade 2 meibum expressibility (moderate pressure required). And,
• Refractory MGD - The failure to respond to at least three types of conventional therapy, including artificial tears, topical or systemic antibiotics and anti-inflammatory treatments and the aforementioned heat-based therapies, over a period of at least 2 years
• Fitzpatrick skin type I-IV - Type V and VI skinned subjects are excluded from the study due to the high risk of pain and focal hypopigmentation
• Mentally fit to give informed consent

You may not qualify if:

• Fitzpatrick skin type V-VI
• History of eyelid scarring
• Infrared meibography evidence of significant acinar gland atrophy (dropout of \>30%) - these patients have been shown not to benefit from heat-based therapies due to end-stage disease
• Pregnancy or lactation
• Active corneal disease such as infectious keratitis, allergic keratoconjunctivitis, pterygium, exposure keratopathy, lagophthalmos, trichiasis or dellen
• Current systemic intake of photosensitive medications, including tetracycline group of drugs.
• History of corneal abnormality or surgery within 3 months

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (2)

Grantham Hospital

Hong Kong, Hong Kong

RECRUITING

HKU Eye Centre

Hong Kong, Hong Kong

RECRUITING

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MeSH Terms

Conditions

Dry Eye Syndromes; Meibomian Gland Dysfunction

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases; Eyelid Diseases

Study Officials

• Kendrick Co SHIH

  The University of Hong Kong, Grantham Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kendrick Co SHIH

CONTACT

94326271; kcshih@hku.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: It is a double-masked randomized study. Assigned treatment of a specific patients would be kept confidential in both the recruited participants and investigators.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: One group of patients receiving radiofrequency treatment (RF) followed by meibomian gland expression (MGX) Another group of patients receiving and MGX

Study Record Dates

• First Submitted: December 10, 2023
• First Posted: January 24, 2024
• Study Start: October 22, 2024
• Primary Completion (Estimated): October 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 27, 2026

Record last verified: 2025-10

Locations

HK (2)