Clinical trial NCT02621593: Feasibility of IPL for Reducing Dry Eye Symptoms Caused by MGD
Official title: Feasibility of Intense Pulsed Light (IPL) for Reducing Dry Eye Symptoms Caused by Meibomian Gland Dysfunction (MGD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dry Eye Syndromes
Keywords: Meibomian Gland Dysfunction
Dry eye symptoms
Intense Pulsed Light
Lead sponsor: Lumenis Be Ltd.
Sponsor class: INDUSTRY
First posted: 2015-12-03
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Tear Break-up time in seconds, using the standard Fluorescein staining method
timeFrame: 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
timeFrame: from Baseline to 3 weeks after the 3rd treatment; 3 weeks after the fourth/final treatment; 6 weeks after the final treatment
measure: Meibomian gland score, using the "Abbreviated MGD grading system for clinical trials"
timeFrame: from Baseline to 3 weeks after the 3rd treatment; 3 weeks after the fourth/final treatment; 6 weeks after the final treatment
measure: Subjective symptoms, using the SPEED questionnaire
timeFrame: from Baseline to 3 weeks after the 3rd treatment; 3 weeks after the fourth/final treatment; 6 weeks after the final treatment
measure: Tear Osmolarity in milliosmol/liter, using a lab-on-a-chip system to simultaneously collect and analyze the electrical impedance of a tear sample
timeFrame: from Baseline to 3 weeks after the 3rd treatment; 3 weeks after the fourth/final treatment; 6 weeks after the final treatment
measure: Lipid Layer Thickness in nanometers, using an interferometer
timeFrame: from Baseline to 3 weeks after the 3rd treatment; 3 weeks after the fourth/final treatment; 6 weeks after the final treatment
Other outcomes:
measure: Incidence of treatment-related adverse events and serious adverse events
timeFrame: 1 day after baseline; 1 week after baseline ; 3 weeks after baseline (Tx2); 6 weeks after baseline (Tx3); 9 weeks after baseline (Tx4/FU1); 12 weeks after baseline (FU2); and 15 weeks after baseline (FU3)
measure: immediate/short term skin response
timeFrame: At Baseline (Tx1); 3 weeks after baseline (Tx2); 6 weeks after baseline (Tx3); and 9 weeks after baseline (Tx4/FU1)
measure: Subjective level of pain/discomfort.
timeFrame: At Baseline (Tx1); 3 weeks after baseline (Tx2); 6 weeks after baseline (Tx3); and 9 weeks after baseline (Tx4/FU1)
Locations:
city: Beverly Hills
country: United States
facility: Gaster Eye Center
state: California
city: Austin
country: United States
facility: Dell Laser Consultants
state: Texas
Study officials:
affiliation: Medical Director, Dell LAser Consultants
name: Steven Dell, MD
role: PRINCIPAL_INVESTIGATOR
References: