Feasibility of IPL for Reducing Dry Eye Symptoms Caused by MGD

Completed · Not applicable

Conditions studied: Dry Eye Syndromes

In brief

The purpose of this study is to evaluate if, in patients with meibomian gland dysfunction (MGD), treatment with the Lumenis M22 Intense Pulsed Light (IPL) system causes a reduction in dry eye symptoms post-treatment, compared to pre-treatment.

Key facts

Study ID

NCT02621593

Run by

Lumenis Be Ltd.

People needed

44

Starts

2015-10-01

Expected to finish

2017-01-01

Last updated by the study team

2017-02-02

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Able to read, understand and sign an Informed Consent (IC) form
• 18-80 years of age
• Fitzpatrick skin type 1-4
• Able and willing to comply with the treatment/follow-up schedule and requirements
• At least 5 non-atrophied glands on each eye's lower eyelid
• Current diagnosis of moderate to severe MGD in both eyes, including 2 of the following 5 criteria:
• Tear break-up time (TBUT) ≤ 10 seconds in both eyes;
• Meibomian gland (MG) score (using the Abbreviated MGD grading system for clinical trials) ≥ 11 in both eyes
• Corneal Fluorescein Staining (CFS) score (using the Baylor grading scheme) ≥ 10 in both eyes;
• Tear Osmolarity ≥ 310 milliosmol/L in both eyes, or a difference higher than 8 milliosmol/L between the two eyes
• SPEED ≥ 10
• Women of child-bearing age are required to be using a reliable method of birth control (such as an intrauterine device, birth control pills, condom with spermicidal, Nuvaring and partner with vasectomy or abstinence) at least 3 months prior to enrollment and throughout the course of the study.

You may not qualify if…

• 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
• Other uncontrolled eye disorders affecting the ocular surface
• 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 who have undergone laser in situ keratomileusis (LASIK) 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 medication and/or herbs that may cause sensitivity to 560-1200 nm light exposure, such as Isotretinoin, Tetracycline, or St. John's Wort
• Over exposure to sun within the past 4 weeks, in the judgment of the treating physician
• Pregnancy and nursing
• Administration of prescription eye drops for dry eye within the past 48 hours, excluding artificial tears
• Radiation therapy to the head or neck within the past year, or planned radiation therapy within 8 weeks after completion of all IPL treatments
• Treatment with chemotherapeutic agent within the past 8 weeks, or planned chemotherapy within 8 weeks after completion of all IPL treatments
• New topical treatments within the area to be treated, or oral therapies within the past 3 months, except over-the-counter acetaminophen-based analgesics (such as Extra Strength Tylenol®) for pain management after study treatment
• Change in dosage of any systemic medication within the past 3 months
• Anticipated relocation or extensive travel outside of the local study area preventing compliance with follow-up within the next 16 weeks
• Any condition revealed during the eligibility screening process whereby the physician deems the subject inappropriate for this study
• Declared legally blind in one eye
• History of migraines, seizures or epilepsy
• IPL treatment within the past 12 months
• Lipiflow treatment, or any equivalent treatment, within the past 12 months
• Expression of the meibomian glands within the past 12 months

Where it is running

• Gaster Eye Center — Beverly Hills, California, United States
• Dell Laser Consultants — Austin, Texas, United States

Full record on ClinicalTrials.gov

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