IPL and MGX Versus MGX Alone in the Treatment of Dry Eye Disease Secondary to MGD

NCT03265652 | Completed

• 2 other identifiers: LUM-VBU-IPL-M22-17-020171-17-SZMC
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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 expression of the meibomian glands. 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; Meibomian Gland Dysfunction

Keywords

Intense Pulsed Light; Meibomian Gland Dysfunction; Dry Eye Disease

Outcome Measures

Primary Outcomes (1)

• Change of baseline TBUT

  Change of Tear break up time in the study eye, from baseline to follow-up

  10 weeks

Secondary Outcomes (2)

• Change from baseline MGA

  10 weeks

• Change from baseline OSDI

  10 weeks

Other Outcomes (7)

• Change from baseline MGYLS

  10 weeks

• Change from baseline TFO

  10 weeks

• Change from baseline Meiboscore

  10 weeks

Study Arms (2)

Intense Pulsed Light (IPL) therapy

EXPERIMENTAL

Subjects with receive 10-15 intense pulsed light (IPL) pulses on the skin of the malar region (both cheeks, from tragus to tragus including the nose) and up to 3 mm from the lid margin of the lower eyelid. Following the administration of IPL pulses, subjects will undergo meibomian gland expression.

Device: Intense Pulsed Light (IPL) therapy

Sham therapy

PLACEBO COMPARATOR

Participants will undergo a sham treatment that will mimic the intense pulsed light (IPL) therapy. The tip of the IPL lightguide will be placed in 10-15 locations on the skin of the malar region (both cheeks, from tragus to tragus including the nose) and up to 3 mm from the lid margin of the lower eyelid, but IPL pulses will not be actually delivered. Following this sham procedure, subjects will undergo meibomian gland expression.

Device: Sham therapy

Interventions

Intense Pulsed Light (IPL) therapy DEVICE

Intense pulsed light therapy 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 treatments over the course of the study, at intervals of 2 weeks. Each treatment will include applications on 10-15 IPL pulses in the malar region and close to the lower eyelids, followed by meibomian gland expression. Meibomian gland expression 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.

Intense Pulsed Light (IPL) therapy

Sham therapy DEVICE

Subjects will receive a total of 4 treatments over the course of the study, at intervals of 2 weeks. Each treatment will include a sham application of IPL on 10-15 locations in the malar region and close to the lower eyelids, followed by meibomian gland expression. Meibomian gland expression 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.

Sham therapy

Eligibility Criteria

• Age: 18 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
• Subject is 18 years or older
• Subject has Fitzpatrick skin type I to IV
• SPEED questionnaire equal or more than 10
• OSDI questionnaire equal or more than 23
• In both eyes, at least 5 non-atrophied meibomian glands on the lower eyelid.
• In both eyes, Tear break up time equal or less than 7 seconds
• In both eyes, MGA (the total meibomian gland score for 15 glands of the lower eyelid) is smaller or equal to 12

You may not qualify if:

• 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 (e.g., Herpes simplex 1 \& 2, Systemic Lupus erythematosus, porphyria)
• Use of photosensitive medication and/or herbs that may cause sensitivity to 560-1200 nm light exposure, such as Isotretinoin, Tetracycline, Doxycycline, or St. John's Wort within 3 months prior to screening
• Over exposure to sun within 4 weeks prior to screening, in the judgment of the investigator
• Administration 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, or planned radiation therapy within 8 weeks after completion of all IPL treatments
• Treatment with chemotherapeutic agent within 8 weeks prior to screening, or planned chemotherapy within 8 weeks after completion of all IPL treatments

Sponsors & Collaborators

• Lumenis Be Ltd.: lead

Study Sites (1)

Shaare Zedek

Jerusalem, Israel

Location

MeSH Terms

Conditions

Dry Eye Syndromes; Meibomian Gland Dysfunction

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases; Eyelid Diseases

Study Officials

• David Zadok, MD

  Shaarei Zedek Hospital ( Jerusalem)

  PRINCIPAL INVESTIGATOR

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: August 22, 2017
• First Posted: August 29, 2017
• Study Start: May 15, 2018
• Primary Completion: April 18, 2019
• Study Completion: April 18, 2019
• Last Updated: February 21, 2020

Record last verified: 2020-02

Locations

IL (1)