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MGD-Meibomian Gland DysfunctionPhase 3MGDNCT06034626

Therapeutic Effectiveness of Different Machines in Intense Pulsed Light Treatment of Meibomian Gland Dysfunction

A Phase 3 study testing Intense pulsed light and 0.3% hyaluronic acid eye drops in people with MGD-Meibomian Gland Dysfunction, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 3 sites in China.

Completed

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

Official record
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Trial summary

This study aimed to determine the therapeutic effectiveness of different machines in intense pulsed light (IPL) treatment of meibomian gland dysfunction (MGD). Subjects diagnosed with MGD underwent three sessions of IPL treatment in a control (M22) treatment group or experimental (OPL-I) treatment group and were… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
MGD-Meibomian Gland Dysfunction
What is being tested?
Intense pulsed light and 0.3% hyaluronic acid eye drops
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
216 participants
Where
3 sitesChina
Study dates
3 Nov 2020to 15 Dec 2021
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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Fitzpatrick skin type I-IV according to sun sensitivity and skin appearance
  • A Standard Patient Evaluation of Eye Dryness (SPEED) score of ≥6
  • Tear breakup time (TBUT) of ≤10 s in the studied eye
  • Corneal fluorescein staining (CFS) score of ≥1 (it is not necessary to consider this criterion if the TBUT is ≤5 s)
  • Meibomian gland secretion score (MGSS) of ≥6 in the studied eye.

Who cannot join

  • Use of prescription eye drops (excluding artificial tears) within 48 hours of recruitment
  • Facial IPL treatment within the prior 12 months
  • Any surgery of the eye or eyelids within the prior six months
  • Ocular surface and eyelid abnormalities
  • Any systemic condition that might cause eye dryness
  • Use of photosensitive drugs within the prior three months
Show all 11Show fewer
  • Precancerous lesions
  • Skin cancer or pigmented lesions in the treatment area
  • Overexposure to the sun within the previous month
  • Ocular infections within the previous six months
  • Uncontrolled infections or immunosuppressive diseases

Trial locations and contacts

3 sites in 1 country.

China3 sites

  • 2nd Affiliated Hospital, School of Medicine, Zhejiang University

    Hangzhou, Zhejiang, 310000

  • Hankou Aier Eye Hospital, Wuhan，Hubei Province

    Wuhan, Hubei, 430000

  • Wuhan Aier Eye Hospital, Wuhan，Hubei Province

    Wuhan, Hubei, 430000

Other trials in China

About this study

This study aimed to determine the therapeutic effectiveness of different machines in intense pulsed light (IPL) treatment of meibomian gland dysfunction (MGD). Subjects diagnosed with MGD underwent three sessions of IPL treatment in a control (M22) treatment group or experimental (OPL-I) treatment group and were followed up three to four weeks after each session. Tear breakup time (TBUT), meibomian gland secretion scores (MGSS), meibomian gland meibum scores (MGMS), corneal fluorescein staining (CFS) scores, and the Standard Patient Evaluation of Eye Dryness (SPEED) was used to assess eye dryness signs and symptoms at baseline and follow-up visits.

Being tested
Intense pulsed light, 0.3% hyaluronic acid eye drops
Keywords
MGD, IPL, Non-inferiority analysis
Medical subject headings
Meibomian Gland Dysfunction

What participants receive

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

  • Intense pulsed lightProcedure or surgery

    Each MGD patient underwent three treatment sessions at three-week intervals and three follow-up examinations over the course of treatment.

  • 0.3% hyaluronic acid eye dropsDrug

    0.3% hyaluronic acid eye drops (Hialid; Santen, Osaka, Japan) four times a day during the study, including the follow-up period.

Study groups in NCT06034626
Study groupRoleWhat they receive
OPL-IExperimentalPatients treated with OPL-I with the dual filter system
Receives: Procedure: Intense pulsed light; Drug: 0.3% hyaluronic acid eye drops
M22Active comparatorPatients treated with OPL-I with the single filter system
Receives: Procedure: Intense pulsed light; Drug: 0.3% hyaluronic acid eye drops

What is being measured

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

  1. SPEED Scores

    Standard Patient Evaluation of Eye Dryness questionnaire

    Measured: Baseline, 1 month, 2 months, 3 months, 4 months

  2. CFS scores

    corneal fluorescein staining scores

    Measured: Baseline, 1 month, 2 months, 3 months, 4 months

  3. TBUT

    Tear breakup time

    Measured: Baseline, 1 month, 2 months, 3 months, 4 months

  4. MGSS

    Meibomian gland secretion scores. The MGSS evaluates the obstruction of meibum along the lower eyelid. Three positions along the lower eyelid were detected (five nasal, five central, and five temporal meibomian glands). A score of 0 indicated secretion by all five glands, a score of 1 indicated secretion by three to four glands, a score of 2 indicated secretion by one or two glands, and a score of 3 indicated no secretion by any glands.

    Measured: Baseline, 1 month, 2 months, 3 months, 4 months

  5. MGMS

    meibomian gland meibum scores. The MGMS evaluates the quality of meibum along the lower eyelid, with a score of 0 indicating clear liquid meibum, a score of 1 indicating cloudy liquid meibum, a score of 2 indicating cloudy granular meibum, and a score of 3 indicating toothpaste-like solid meibum).

    Measured: Baseline, 1 month, 2 months, 3 months, 4 months

Secondary outcomes (2)

  1. BCVA

    best-corrected visual acuity

    Measured: Baseline, 4 months

  2. IOP

    intraocular pressure measurements

    Measured: Baseline, 4 months

Timeline

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

  1. First posted13 Sep 2023
  2. Study start3 Nov 2020
  3. Primary completion10 Aug 2021
  4. Study completion15 Dec 2021

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
Model description
The trial aimed to assess therapeutic effectiveness of the study treatment arm (OPL-I with the dual filter system; Miracle Laser systems, Wuhan, China) to the control treatment arm (M22 with a single filter; Lumenis, Yokneam, Israel). Each MGD patient underwent three treatment sessions at three-week intervals and three follow-up examinations over the course of treatment.
Masking
Single blind
Who is masked
Participant
Enrolment
216 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06034626
Sponsor's protocol ID
2020-210
Acronym
MGD
Status last verified
Aug 2023
First submitted
29 Aug 2023
Last updated
13 Sep 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: For patients' privacy reasons

Publications

  • Toyos R, McGill W, Briscoe D. Intense pulsed light treatment for dry eye disease due to meibomian gland dysfunction; a 3-year retrospective study. Photomed Laser Surg. 2015 Jan;33(1):41-6. doi: 10.1089/pho.2014.3819.

    PubMed 25594770

  • Yan X, Hong J, Jin X, Chen W, Rong B, Feng Y, Huang X, Li J, Song W, Lin L, Cheng Y. The Efficacy of Intense Pulsed Light Combined With Meibomian Gland Expression for the Treatment of Dry Eye Disease Due to Meibomian Gland Dysfunction: A Multicenter, Randomized Controlled Trial. Eye Contact Lens. 2021 Jan 1;47(1):45-53. doi: 10.1097/ICL.0000000000000711.

    PubMed 32452923

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Intense pulsed light and 0.3% hyaluronic acid eye drops in people with MGD-Meibomian Gland Dysfunction, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 3 sites in China.

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 5 inclusion and 11 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 13 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in China. 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. 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?

SPEED Scores (time frame: Baseline, 1 month, 2 months, 3 months, 4 months). The study lists 5 primary outcomes in all. 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 NCT06034626, which also lists 2 linked publications.

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 13 Sep 2023.

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