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

Primary Purpose

Meibomian Gland Dysfunction (Disorder), Dry Eye Syndromes

Status

Completed

Phase

Phase 3

Locations

Thailand

Study Type

Interventional

Intervention

Intense Pulsed Light

Standard treatment

About this trial

This is an interventional treatment trial for Meibomian Gland Dysfunction (Disorder) focused on measuring Intense pulsed light, Meibomian gland dysfunction, Dry eye, cytokines

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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
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

Sites / Locations

Yonrawee Piyacomn

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

IPL group

sham-IPL group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

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

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

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

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

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

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)

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

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

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

one of the tear inflammatory cytokines

Full Information

NCT ID

NCT03518398

First Posted

April 16, 2018

Last Updated

June 18, 2019

Sponsor

Chulalongkorn University

1. Study Identification

Unique Protocol Identification Number

NCT03518398

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2019

Overall Recruitment Status

Completed

Study Start Date

July 3, 2018 (Actual)

Primary Completion Date

April 2, 2019 (Actual)

Study Completion Date

April 2, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Chulalongkorn University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Meibomian Gland Dysfunction (Disorder), Dry Eye Syndromes

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

114 (Actual)

8. Arms, Groups, and Interventions

Arm Title

IPL group

Arm Type

Experimental

Arm Description

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

Arm Title

sham-IPL group

Arm Type

Sham Comparator

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Intense Pulsed Light

Intervention Description

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

Intervention Type

Combination Product

Intervention Name(s)

Standard treatment

Intervention Description

warm compression, lid scrub and non-preservative ocular lubricants

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

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

Secondary Outcome Measure Information:

Title

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

Description

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.

Time Frame

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

Title

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

Description

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

Time Frame

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

Title

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

Description

directly visualising the morphology of meibomian glands in vivo

Time Frame

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

Title

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

Description

Time Frame

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

Title

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

Description

number of glands expressible after applying force onto the eyelids

Time Frame

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

Title

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

Description

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

Time Frame

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

Title

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

Description

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

Time Frame

day 0, 45, month 3, month 6

Title

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

Description

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

Time Frame

day 0, month 3

Title

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

Description

one of the tear inflammatory cytokines

Time Frame

day 0, month 3

Title

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

Description

one of the tear inflammatory cytokines

Time Frame

day 0, month 3

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yonrawee Piyacomn, MD

Organizational Affiliation

Department of Ophthalmology, Faculty of Medicine, Chulalongkorn University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Yonrawee Piyacomn

City

Bangkok

ZIP/Postal Code

10330

Country

Thailand

12. IPD Sharing Statement

Plan to Share IPD

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

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