Feasibility of IPL for Reducing Dry Eye Symptoms Caused by MGD

NCT ID: NCT02621593

Last Updated: 2017-02-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-10-31
• Study Completion Date: 2017-01-31

Brief 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.

Detailed 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.

Conditions

Dry Eye Syndromes

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment of dry eye secondary to MGD

Intervention: Treatment of dry eye symptoms secondary to MGD with the M22-IPL system

Group Type: EXPERIMENTAL

M22-IPL

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lumenis Be Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Steven Dell, MD

Role: PRINCIPAL_INVESTIGATOR

Medical Director, Dell LAser Consultants

Locations

Gaster Eye Center

Beverly Hills, California, United States

Dell Laser Consultants

Austin, Texas, United States

Countries

United States

Other Identifiers

LUM-VBU-M22-15-01

Identifier Type: -

Identifier Source: org_study_id