Effectiveness of Intense Pulsed Light for Improving Dry Eye Syndrome

NCT03396913 | Completed Results FDA Device

• 1 other identifier: LUM-VBU-M22-IPL-17-01
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 2

Brief Summary

The aim of the current study is to examine the contribution of intense pulsed light (IPL) for relieving signs and symptoms of dry eye due to meibomian gland dysfunction. The effect of IPL will be examined in a study designed as a randomized controlled trial. In the study arm, subjects will undergo 4 treatment sessions, consisting of IPL pulses immediately followed by meibomian gland expression (MGX). In the control arm, subjects will undergo the same treatments, except that the IPL pulses will be disabled. For each subject, the duration of the study will be 10 weeks, as explained in the detailed description.

Conditions

Dry Eye Syndrome

Keywords

Intense Pulsed Light; Meibomian Gland Dysfunction; Dry Eye Disease

Outcome Measures

Primary Outcomes (1)

• Change of Baseline Tear Breakup Time (TBUT)

  Change of Tear breakup time (TBUT) in the study eye, from baseline to follow-up. TBUT is measured in seconds. Higher values mean better outcome.

  10 weeks

Secondary Outcomes (2)

• Change From Baseline Ocular Surface Disease Index (OSDI)

  10 weeks

• Change From Baseline Eye Dryness Score (EDS)

  10 weeks

Other Outcomes (10)

• Qualitative Assessment of Eyelid Appearance

  10 weeks

• Meiboscore

  10 weeks

• Percentage of Eyes With Normal Tear Break-Up Time (TBUT)

  10 weeks

Study Arms (2)

IPL followed by Meibomian Gland Expression (MGX)

EXPERIMENTAL

Subjects in the experimental arm with receive IPL followed by MGX: IPL pulses will be administered on the skin of the malar region (both cheeks, from tragus to tragus including the nose) and below the lower eyelids. Following IPL therapy, subjects will undergo MGX of both eyelids in both eyes.

Device: IPL; Procedure: MGX

Sham IPL followed by MGX

SHAM COMPARATOR

Subjects in the sham comparator arm with receive Sham IPL followed by MGX: Sham IPL pulses will be administered on the skin of the malar region (both cheeks, from tragus to tragus including the nose) and below the lower eyelids. Following Sham IPL therapy, subjects will undergo MGX of both eyelids in both eyes.

Device: Sham IPL; Procedure: MGX

Interventions

IPL DEVICE

Intense pulsed light (IPL) is a non-invasive and non-laser light treatment that is FDA-approved for various conditions in dermatology. Subjects will receive a total of 4 IPL treatments over the course of the study, at intervals of 2 weeks. Each treatment will include applications of 10-15 IPL pulses in the malar region and close to the lower eyelids, followed by meibomian gland expression.

IPL followed by Meibomian Gland Expression (MGX)

Sham IPL DEVICE

Sham intense pulsed light (IPL) will be implemented with an IPL device in which all light is blocked by a filter. Subjects will receive a total of 4 sham treatments over the course of the study, at intervals of 2 weeks. Each treatment will include applications of10-15 sham pulses in the malar region and close to the lower eyelids, followed by meibomian gland expression.

Sham IPL followed by MGX

MGX PROCEDURE

Meibomian gland expression (MGX) will be implemented by squeezing the meibomian glands with the aid of two Q-tips positioned on either side of the meibomian glands, or with a meibomian gland expressor forceps

IPL followed by Meibomian Gland Expression (MGX); Sham IPL followed by MGX

Eligibility Criteria

• Age: 22 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is able to read, understand and sign an Informed Consent (IC) form
• years of age
• Subject is able and willing to comply with the treatment/follow-up (FU) schedule and requirements
• In the study eye, Tear Breakup time (TBUT) ≤ 7 seconds
• In the study eye, Meibomian Gland Score (MGS) ≤ 12
• In the study eye, at least 5 non-atrophied meibomian glands in the lower eyelid
• Symptoms self-assessed using the Ocular Surface Disease Index (OSDI) questionnaire ≥ 23

You may not qualify if:

• Fitzpatrick skin type V or VI
• Contact lens wear within the month prior to screening
• Unwilling to discontinue use of contact lenses for the duration of the study
• Ocular surgery or eyelid surgery, within 6 months prior to screening
• Neuro-paralysis in the planned treatment area, within 6 months prior to screening
• Other uncontrolled eye disorders affecting the ocular surface, for example active allergies
• Current use of punctal plugs
• Pre-cancerous lesions, skin cancer or pigmented lesions in the planned treatment area
• Uncontrolled infections or uncontrolled immunosuppressive diseases
• Subjects with ocular infections, within 6 months prior to screening
• Prior history of cold sores or rashes in the perioral area or in the planned treatment area that could be stimulated by light at a wavelength of 560 nm to 1200 nm, including: Herpes simplex 1 \& 2, Systemic Lupus erythematosus, and porphyria
• Within 3 months prior to screening, use of photosensitive medication and/or herbs that may cause sensitivity to 560-1200 nm light exposure, including: Isotretinoin, Tetracycline, Doxycycline, and St. John's Wort
• Over exposure to sun, within 4 weeks prior to screening
• Use of prescription eye drops for dry eye, within 7 days prior to screening, excluding artificial tears and glaucoma drops
• Radiation therapy to the head or neck, within 12 months prior to screening

Sponsors & Collaborators

• Lumenis Be Ltd.: lead

Study Sites (2)

Toyos Clinic

Nashville, Tennessee, 37215, United States

Location

Dell Laser Consultants

Austin, Texas, 78746, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes; Meibomian Gland Dysfunction

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases; Eyelid Diseases

Results Point of Contact

• Title: Yair Manor, Clinical Director
• Organization: Lumenis

yair.manor@lumenis.com

+972-52-3763416

Study Officials

• Steven J Dell, MD

  Dell Laser Consultants

  PRINCIPAL INVESTIGATOR

• Rolando Toyos, MD

  Toyos Clinic

  PRINCIPAL INVESTIGATOR

• Neel Desai, MD

  The Eye Institute of West Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Subjects in the study arm will receive a series of IPL pulses using the M22 IPL handpiece. In subjects of the control arm, the device will be disabled. The subject will feel the lightguide on the skin, will hear clicking sounds, but no light will be actually produced by the M22 device. Since during treatment both eyes of the subject will be fully occluded, no subject will be able to see if the treatment is actual or sham. There is no way to completely mask the subjects, since the IPL generally causes slight redness of the skin, and in some patients is may also cause some discomfort
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Subjects will be randomized 1:1 to a study arm and a control arm. Subjects in the study arm will be treated with IPL and meibomian gland expression. Subjects in the control arm will be treated with sham and meibomian gland expression.

Study Record Dates

• First Submitted: December 28, 2017
• First Posted: January 11, 2018
• Study Start: January 10, 2018
• Primary Completion: August 15, 2019
• Study Completion: August 15, 2019
• Last Updated: December 9, 2020
• Results First Posted: December 9, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)