Effectiveness of Intense Pulsed Light for Improving Dry Eye Syndrome

Completed · Not applicable · Has a placebo group

Conditions studied: Dry Eye Syndrome

In brief

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.

Key facts

Study ID: NCT03396913
Run by: Lumenis Be Ltd.
People needed: 88
Starts: 2018-01-10
Expected to finish: 2019-08-15
Last updated by the study team: 2020-12-09

Who can join

Age: 22 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Subject is able to read, understand and sign an Informed Consent (IC) form
22-85 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
Planned radiation therapy, within 8 weeks after the last treatment session
Treatment with chemotherapeutic agent, within 8 weeks prior to screening
Planned chemotherapy, within 8 weeks after the last treatment session
New topical treatments within the area to be treated, or oral therapies, within 3 months prior to screening- except over-the-counter acetaminophen-based analgesics for pain management, new oral omega 3 fatty acid supplements and topical artificial tears
Change in dosage of any systemic medication, within 3 months prior to screening
Anticipated relocation or extensive travel outside of the local study area preventing compliance with follow-up over the study period
Legally blind in either eye
History of migraines, seizures or epilepsy
Facial IPL treatment, within 12 months prior to screening
Any thermal treatment of the eyelids, including Lipiflow, within 6 months prior to screening

Where it is running

Toyos Clinic — Nashville, Tennessee, United States
Dell Laser Consultants — Austin, Texas, United States

Full record on ClinicalTrials.gov

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