Feasibility of IPL for Reducing Dry Eye Symptoms Caused by MGD

Dry Eye Syndromes Clinical Trial

Official title:

Feasibility of Intense Pulsed Light (IPL) for Reducing Dry Eye Symptoms Caused by Meibomian Gland Dysfunction (MGD)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02621593
• Other study ID #: LUM-VBU-M22-15-01
• Status: Completed
• Phase: N/A
• First received: November 24, 2015
• Last updated: February 1, 2017
• Start date: October 2015
• Est. completion date: January 2017

Study information

• Verified date: February 2017
• Source: Lumenis Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Dry Eye Syndromes
• Keratoconjunctivitis Sicca

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United States	Dell Laser Consultants	Austin	Texas
United States	Gaster Eye Center	Beverly Hills	California

Sponsors (1)

Lead Sponsor	Collaborator
Lumenis Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incidence of treatment-related adverse events and serious adverse events	Evaluation will be done by subject's report and/or by the physician's judgment	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)
Other	immediate/short term skin response	Evaluation will be done by the physician judgment	At Baseline (Tx1); 3 weeks after baseline (Tx2); 6 weeks after baseline (Tx3); and 9 weeks after baseline (Tx4/FU1)
Other	Subjective level of pain/discomfort.	Evaluation will be done by the subject, using a Visual Analog Scale (VAS)	At Baseline (Tx1); 3 weeks after baseline (Tx2); 6 weeks after baseline (Tx3); and 9 weeks after baseline (Tx4/FU1)
Primary	Tear Break-up time in seconds, using the standard Fluorescein staining method	The number of seconds that elapse between the last blink of the eye to the appearance of the first dry spot in the tear film	from Baseline to 3 weeks after the 3rd treatment and 3 weeks after the fourth/final treatment
Secondary	Corneal fluorescein staining score, using the Baylor Scheme	The cornea will be viewed and logically divided to 5 zones: central, superior, inferior, temporal and nasal. In each of the 5 zones, grading will be as follows: 0 dots = 0; 1-5 dots = 1; 16-30 dots = 3; > 30 dots = 4; One point will be added to the score in case of 1 area of confluent staining. Two points will be added to the score in case of two or more areas of confluent staining. The total score is the sum of scores in the 5 zones	from Baseline to 3 weeks after the 3rd treatment; 3 weeks after the fourth/final treatment; 6 weeks after the final treatment
Secondary	Meibomian gland score, using the "Abbreviated MGD grading system for clinical trials"	Thickening of the upper lid margin (0-3, where 0 is normal and 3 is severe). A value of at least 1 (mild) is consistent with DED.; Vascularity of the upper lid margin (0-3, where 0 is normal and 3 is severe engorgement). A value of at least 1 (mild engorgement) is consistent with DED.; Number of telangiectasias (0-3, where 0 = none, 1 = single, 2 = two to four and 3 = above four). A value of at least 2 (2-4 telangiectasias) is consistent with DED.; Of the central 10 glands of the upper eyelid- number of plugged glands: a value of at least 2 is consistent with DED. The total score is computed by summing the scores of the 8 categories above.	from Baseline to 3 weeks after the 3rd treatment; 3 weeks after the fourth/final treatment; 6 weeks after the final treatment
Secondary	Subjective symptoms, using the SPEED questionnaire	SPEED is a validated questionnaire for quantifying the subjective symptoms of DED. The questionnaire will be filled by the study investigator (with questions answered by the subject). In 4 symptoms are evaluated: (1) dryness, grittiness or scratchiness; (2) Soreness or Irritation; (3) Burning or watering; and (4) Eye fatigue. Two types of questions are asked about these symptoms: frequency and severity.; In the Frequency questions, subjects evaluate the 4 symptoms above on a 0-3 scale: 0 = Never; 1 = Sometimes; 2 = Often; and 3 = All the time.; In the Severity questions, subjects evaluate the 4 symptoms above on a 0-4 scale: 0 = No problems; 1 = Tolerable (not perfect but not uncomfortable); 2 = Uncomfortable (irritating but does not interfere with my day); 3 = Bothersome (irritating and interferes with my day); and (4) Intolerable (unable to perform my daily tasks). The total score is the sum of the Frequency answers and the Severity answers.	from Baseline to 3 weeks after the 3rd treatment; 3 weeks after the fourth/final treatment; 6 weeks after the final treatment
Secondary	Tear Osmolarity in milliosmol/liter, using a lab-on-a-chip system to simultaneously collect and analyze the electrical impedance of a tear sample	In this current study, tear osmolarity will be measured using a lab-on-a-chip system to simultaneously collect and analyze the electrical impedance of a tear sample (TearLab, San Diego, CA, USA). A small tear sample of 50 nL will be collected from the lower meniscus, using a disposable test chip by passive capillary action, and transferred to the device. Several seconds after the transfer, readings will be given in milliOsmol/L	from Baseline to 3 weeks after the 3rd treatment; 3 weeks after the fourth/final treatment; 6 weeks after the final treatment
Secondary	Lipid Layer Thickness in nanometers, using an interferometer	lipid layer thickness will be measured using an interferometer. In interferometry, when white light is projected over the cornea, a color interference pattern is produced due to specular reflection at the lipid-aqueous interface. The reflected colors from the tear film are captured on a high-resolution video. Each recorded pixel is analyzed, and compared with a color progression table. The output is expressed as interference color units (ICUS), which correlate with lipid layer thickness	from Baseline to 3 weeks after the 3rd treatment; 3 weeks after the fourth/final treatment; 6 weeks after the final treatment