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

NCT03518398 | Completed Phase 3 DMC

• 1 other identifier: Yonrawee Piyacomn
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Meibomian Gland Dysfunction (Disorder); Dry Eye Syndromes

Keywords

Intense pulsed light; Meibomian gland dysfunction; Dry eye; cytokines

Outcome Measures

Primary Outcomes (1)

• Change in fluorescein tear break-up time at month 6 using fluorescein technique

  time elapsed from the last complete eyelid blink until appearance of the first dry spot on the cornea

  day 0, 15, 45, month 3, month 6

Secondary Outcomes (10)

• Change in dry eye symptoms using Ocular Surface Disease Index (OSDI), a questionnaire, at month 6

  day 0, 15, 45, month 3, month 6

• Change in lipid layer thickness at month 6 using LipiView interferometer (TearScience inc., Morrisville,NC)

  day 0, 15, 45, month 3, month 6

• Change in Meibomian gland's anatomy by Meiboscore using Meibography at month 6 using Keratograph 5M (OCULUS, Wetzlar, Germany)

  day 0, 15, 45, month 3, month 6

• Change in ocular surface staining at month 6 using fluorescein staining technique

  day 0, 15, 45, month 3, month 6

• Change in Meibomian gland expressibility at month 6 after applying the force onto the eyelids using meibomian gland evaluator

  day 0, 15, 45, month 3, month 6

Study Arms (2)

IPL group

EXPERIMENTAL

IPL 9-13 J/cm2 according to Fitzpatrick's skin type on day 0, 15, 45

Device: Intense Pulsed Light; Combination Product: Standard treatment

sham-IPL group

SHAM COMPARATOR

IPL 0 J/cm2 according to Fitzpatrick's skin type on day 0, 15, 45

Combination Product: Standard treatment

Interventions

Intense Pulsed Light DEVICE

E\> Eye (E-SWIN, Paris, France) IPL machine

IPL group

Standard treatment COMBINATION_PRODUCT

warm compression, lid scrub and non-preservative ocular lubricants

IPL group; sham-IPL group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to read, understand and sign an informed consent form
• years of age
• Fitzpatrick skin type 1-5
• Able and willing to comply with the treatment /follow-up schedule and requirements
• Presence of meibomian gland on each lower eyelid's meibography
• Current diagnosis of stage1-4 of MGD in both eyes, according to the International Workshop on Meibomian Gland Dysfunction: Report of the Subcommittee on Management and Treatment of Meibomian Gland Dysfunction

You may not qualify if:

• Contact lens wearer within the past 1 month and throughout the study
• Recent ocular surgery or eyelid surgery within the past 6 months
• Neuro-paralysis in the planned treatment area within the past 6 months
• Current use of punctual plugs
• Pre-cancerous lesions, skin cancer or pigmented lesions in the planned treatment area
• Uncontrolled infections or uncontrolled immunosuppressive diseases
• Subjects who have undergone refractive surgery within the past 6 months
• Diseases in the planned treatment area that could be stimulated by light at 560 nm to 1200 nm (e.g.,Herpes simplex 1 and 2, Systemic Lupus Erythematosus, porphyria)
• Use of photosensitive medications and/or herbs that may cause sensitivity to 560-1200 nm light exposure, such as isotretinoin, tetracycline, or St. John's Wort
• Pregnancy and lactation
• Radiation therapy to the head or neck within the past year, or planned radiation therapy throughout study period
• Treatment with chemotherapeutic agent within the past 8 weeks, or planned chemotherapy throughout study period
• Any condition revealed during the eligibility screening process whereby the physician deems the subject inappropriate for this study
• Declared legally blind in one eye
• IPL treatment within the past 12 months

Sponsors & Collaborators

• Chulalongkorn University: lead

Study Sites (1)

Yonrawee Piyacomn

Bangkok, 10330, Thailand

Location

MeSH Terms

Conditions

Meibomian Gland Dysfunction; Dry Eye Syndromes

Interventions

Intense Pulsed Light Therapy

Condition Hierarchy (Ancestors)

Eyelid Diseases; Eye Diseases; Lacrimal Apparatus Diseases

Intervention Hierarchy (Ancestors)

Phototherapy; Therapeutics

Study Officials

• Yonrawee Piyacomn, MD

  Department of Ophthalmology, Faculty of Medicine, Chulalongkorn University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Yonrawee Piyacomn, MD, FICO, Principal Investigator, Fellow of Cornea and Refractive Surgery Unit, Department of Ophthalmology, Faculty of Medicine, Chulalongkorn University

Study Record Dates

• First Submitted: April 16, 2018
• First Posted: May 8, 2018
• Study Start: July 3, 2018
• Primary Completion: April 2, 2019
• Study Completion: April 2, 2019
• Last Updated: June 19, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)