Overview

This trial is active, not recruiting.

Condition dry eye syndromes
Treatment m22-ipl
Sponsor Lumenis Ltd.
Start date October 2015
End date November 2016
Trial size 44 participants
Trial identifier NCT02621593, LUM-VBU-M22-15-01

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Intervention: Treatment of dry eye symptoms secondary to MGD with the M22-IPL system
m22-ipl
The IPL hand piece operates at a spectrum of 400-1200nm with 7 different filters that can be easily inserted to the hand piece to treat different conditions. The IPL hand piece also includes 2 different sapphire cooled light guides of 8x15mm and 15x35mm. The cut-off filters that will be used for this evaluation are filters blocking wavelengths of 560 and 595 nm.

Primary Outcomes

Measure
Tear Break-up time in seconds, using the standard Fluorescein staining method
time frame: from Baseline to 3 weeks after the 3rd treatment and 3 weeks after the fourth/final treatment

Secondary Outcomes

Measure
Corneal fluorescein staining score, using the Baylor Scheme
time frame: from Baseline to 3 weeks after the 3rd treatment; 3 weeks after the fourth/final treatment; 6 weeks after the final treatment
Meibomian gland score, using the "Abbreviated MGD grading system for clinical trials"
time frame: from Baseline to 3 weeks after the 3rd treatment; 3 weeks after the fourth/final treatment; 6 weeks after the final treatment
Subjective symptoms, using the SPEED questionnaire
time frame: from Baseline to 3 weeks after the 3rd treatment; 3 weeks after the fourth/final treatment; 6 weeks after the final treatment
Tear Osmolarity in milliosmol/liter, using a lab-on-a-chip system to simultaneously collect and analyze the electrical impedance of a tear sample
time frame: from Baseline to 3 weeks after the 3rd treatment; 3 weeks after the fourth/final treatment; 6 weeks after the final treatment
Lipid Layer Thickness in nanometers, using an interferometer
time frame: from Baseline to 3 weeks after the 3rd treatment; 3 weeks after the fourth/final treatment; 6 weeks after the final treatment

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

Inclusion Criteria: 1. Able to read, understand and sign an Informed Consent (IC) form 2. 18-80 years of age 3. Fitzpatrick skin type 1-4 4. Able and willing to comply with the treatment/follow-up schedule and requirements 5. At least 5 non-atrophied glands on each eye's lower eyelid 6. 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 7. 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. Exclusion Criteria: 1. Contact lens wearer within the past 1 month and throughout the study 2. Recent ocular surgery or eyelid surgery within the past 6 months 3. Neuro-paralysis in the planned treatment area within the past 6 months 4. Other uncontrolled eye disorders affecting the ocular surface 5. Current use of punctal plugs 6. Pre-cancerous lesions, skin cancer or pigmented lesions in the planned treatment area 7. Uncontrolled infections or uncontrolled immunosuppressive diseases 8. Subjects who have undergone laser in situ keratomileusis (LASIK) surgery within the past 6 months 9. 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) 10. 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 11. Over exposure to sun within the past 4 weeks, in the judgment of the treating physician 12. Pregnancy and nursing 13. Administration of prescription eye drops for dry eye within the past 48 hours, excluding artificial tears 14. Radiation therapy to the head or neck within the past year, or planned radiation therapy within 8 weeks after completion of all IPL treatments 15. Treatment with chemotherapeutic agent within the past 8 weeks, or planned chemotherapy within 8 weeks after completion of all IPL treatments 16. 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 17. Change in dosage of any systemic medication within the past 3 months 18. Anticipated relocation or extensive travel outside of the local study area preventing compliance with follow-up within the next 16 weeks 19. Any condition revealed during the eligibility screening process whereby the physician deems the subject inappropriate for this study 20. Declared legally blind in one eye 21. History of migraines, seizures or epilepsy 22. IPL treatment within the past 12 months 23. Lipiflow treatment, or any equivalent treatment, within the past 12 months 24. Expression of the meibomian glands within the past 12 months

Additional Information

Official title Feasibility of Intense Pulsed Light (IPL) for Reducing Dry Eye Symptoms Caused by Meibomian Gland Dysfunction (MGD)
Principal investigator Steven Dell, MD
Description The IPL module has FDA clearance (K142860) for a wide range of indications, including benign cavernous hemangiomas, benign venous malformations, telangiectasia, port-wine stains, pigmented lesions and erythema of rosacea. As shown by a retrospective study, in over 85% of the cases, using IPL in subjects with ocular rosacea also alleviated the symptoms of DED caused by MGD. No serious adverse events were recorded, suggesting that IPL therapy administered close to the ocular orbits is safe (provided that the eyes are shielded). However, the above mentioned study was retrospective. Therefore, additional evidence is needed in order to substantiate the hypothesis that alleviation of MGD symptom was facilitated by IPL treatments. The aim of the current study is to assess the safety and efficacy of IPL treatment for reducing the symptoms of dry eye disease (DED) in subjects with MGD. The study hypothesis is that in a study population of subjects diagnosed with moderate to severe MGD, 4 sessions of IPL therapy with the M22 system, followed by expression of the MGs, will cause a significant increase in tear break-up time post-treatment, compared to pre-treatment.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Lumenis Ltd..