AzTrials
AzTrials

Meibomian Gland Dysfunction (Disorder)Phase 3NCT03518398

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

A Phase 3 study testing Intense Pulsed Light and Standard treatment in people with Meibomian Gland Dysfunction (Disorder) and Dry Eye Syndromes, run by Chulalongkorn University at 1 site in Thailand.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 to 80 yearsHealthy volunteers can take part
What is being tested?
Intense Pulsed Light and Standard treatment
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
114 participants
Where
1 siteThailand
Study dates
3 Jul 2018to 2 Apr 2019
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Able to read, understand and sign an informed consent form
  • 18-80 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

Who cannot join

  • 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
Show all 17Show fewer
  • 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
  • Lipiflow treatment, or any equivalent treatments, within the past 12 months
  • Any anti-glaucomatous eye drop uses within the past 3 months and throughout the study period

Trial locations and contacts

1 site in 1 country.

Thailand1 site

  • Yonrawee Piyacomn

    Bangkok, 10330

Other trials in Thailand

About this study

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.

Being tested
Intense Pulsed Light, Standard treatment
Keywords
Intense pulsed light, Meibomian gland dysfunction, Dry eye, cytokines
Medical subject headings
Meibomian Gland Dysfunction, Dry Eye Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intense Pulsed LightDevice

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

  • Standard treatmentCombination product

    warm compression, lid scrub and non-preservative ocular lubricants

Study groups in NCT03518398
Study groupRoleWhat they receive
IPL groupExperimentalIPL 9-13 J/cm2 according to Fitzpatrick's skin type on day 0, 15, 45
Receives: Device: Intense Pulsed Light; Combination Product: Standard treatment
sham-IPL groupSham comparatorIPL 0 J/cm2 according to Fitzpatrick's skin type on day 0, 15, 45
Receives: Combination Product: Standard treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

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

Secondary outcomes (10)

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

    a 12-item questionnaire designed to provide a rapid assessment of the symptoms of ocular irritation consistent with dry eye disease and their impact on vision-related functioning.

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

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

    quantitative values of the tear-film lipid layer depth or thickness by imaging the surface contour of the tear film, lipid layer thickness measurement

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

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

    directly visualising the morphology of meibomian glands in vivo

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

  4. Change in ocular surface staining at month 6 using fluorescein staining technique

    fluorescein dye which is a mildly invasive stain that marks the tear film and defects in the corneal and conjunctival epithelium. The investigators use National Eye Institute (NEI) grading for ocular surface staining score in this study

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

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

    number of glands expressible after applying force onto the eyelids

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

  6. Change in Meibum quality at month 6 after applying the force onto the eyelids using meibomian gland evaluator

    quality of the meibum content after applying the force onto the eyelids

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

  7. Change in tear osmolarity at month 6 using TearLab Osmolarity System (San Diego, CA)

    concentration of the tear : The investigators use TearLab Osmolarity System (San Diego, CA)

    Measured: day 0, 45, month 3, month 6

  8. Change in tear production test (Schirmer's test) at month 3 using calibrated strips of a non-toxic filter paper

    is used determine whether the lacrimal glands produce enough tears to keep the eyes adequately moist

    Measured: day 0, month 3

  9. Change in tear cytokines Interleukins-1 receptor antagonist (IL-1Ra) at month 3 using Bio-Plex® 200 system (Bio-Rad, Hercules, CA)

    one of the tear inflammatory cytokines

    Measured: day 0, month 3

  10. Change in tear cytokines Interleukins-6 at month 3 using Bio-Plex® 200 system (Bio-Rad, Hercules, CA)

    one of the tear inflammatory cytokines

    Measured: day 0, month 3

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 May 2018
  2. Study start3 Jul 2018
  3. Primary completion2 Apr 2019
  4. Study completion2 Apr 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
114 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03518398
Sponsor's protocol ID
Yonrawee Piyacomn
Status last verified
Jun 2019
First submitted
16 Apr 2018
Last updated
19 Jun 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Intense Pulsed Light and Standard treatment in people with Meibomian Gland Dysfunction (Disorder) and Dry Eye Syndromes, run by Chulalongkorn University at 1 site in Thailand.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in fluorescein tear break-up time at month 6 using fluorescein technique (time frame: day 0, 15, 45, month 3, month 6). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03518398.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2019.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in