IPL and MGX Versus MGX Alone in the Treatment of Dry Eye Disease Secondary to MGD

NCT ID: NCT03265652

Last Updated: 2020-02-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-15
• Study Completion Date: 2019-04-18

Brief Summary

The aim of the current study is to examine the contribution of intense pulsed light (IPL) for relieving signs and symptoms of dry eye due to meibomian gland dysfunction. The effect of IPL will be examined in a study designed as a randomized controlled trial. In the study arm, subjects will undergo 4 treatment sessions, consisting of IPL pulses immediately followed by expression of the meibomian glands. In the control arm, subjects will undergo the same treatments, except that the IPL pulses will be disabled. For each subject, the duration of the study will be 10 weeks, as explained in the detailed description,

Detailed Description

Outcome measures (tear break-up time, tear film osmolarity, meibomian gland assessment, number of meibomian glands yielding liquid secretion in lower eyelid , meibography, self-assessed symptoms and close up photos of the lid margins) will be measured at baseline. All subjects will receive 4 treatments at 2 weeks intervals. In each treatment session, a subject allocated to the study group will be treated with IPL administered in the malar region, from tragus to tragus including the nose, 2-3 mm below the lower eyelids. Immediately following the IPL administration, the meibomian glands will be manually expressed from both eyelids. Subjects in the control arm will receive exactly the same treatment, except that the IPL administration will be sham. A single follow-up will occur at 10 weeks after the baseline (or 4 weeks after the 4th treatment session). At the follow-up, the changes in the outcome measures will be evaluated, and compared between the two arms.

For each subject, the duration of the study will be 10 weeks: 1st treatment at baseline; 2nd treatment at 2 weeks after baseline; 3rd treatment at 4 weeks after baseline; 4th treatment at 6 weeks after baseline; and a single follow-up at 10 weeks after baseline).

Statistically significant differences between the two arms will support the study hypothesis that IPL treatment itself provides relief to both signs and symptoms of dry eye disease.

Conditions

Dry Eye; Meibomian Gland Dysfunction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Intense Pulsed Light (IPL) therapy

Subjects with receive 10-15 intense pulsed light (IPL) pulses on the skin of the malar region (both cheeks, from tragus to tragus including the nose) and up to 3 mm from the lid margin of the lower eyelid. Following the administration of IPL pulses, subjects will undergo meibomian gland expression.

Group Type: EXPERIMENTAL

Intense Pulsed Light (IPL) therapy

Intervention Type: DEVICE

Intense pulsed light therapy is a non-invasive and non-laser light treatment that is FDA-approved for various conditions in dermatology. Subjects will receive a total of 4 treatments over the course of the study, at intervals of 2 weeks. Each treatment will include applications on 10-15 IPL pulses in the malar region and close to the lower eyelids, followed by meibomian gland expression. Meibomian gland expression will be implemented by squeezing the meibomian glands with the aid of two Q-tips positioned on either side of the meibomian glands, or with a meibomian gland expressor forceps.

Sham therapy

Participants will undergo a sham treatment that will mimic the intense pulsed light (IPL) therapy. The tip of the IPL lightguide will be placed in 10-15 locations on the skin of the malar region (both cheeks, from tragus to tragus including the nose) and up to 3 mm from the lid margin of the lower eyelid, but IPL pulses will not be actually delivered. Following this sham procedure, subjects will undergo meibomian gland expression.

Group Type: PLACEBO_COMPARATOR

Sham therapy

Intervention Type: DEVICE

Subjects will receive a total of 4 treatments over the course of the study, at intervals of 2 weeks. Each treatment will include a sham application of IPL on 10-15 locations in the malar region and close to the lower eyelids, followed by meibomian gland expression. Meibomian gland expression will be implemented by squeezing the meibomian glands with the aid of two Q-tips positioned on either side of the meibomian glands, or with a meibomian gland expressor forceps.

Interventions

Intense Pulsed Light (IPL) therapy

Intense pulsed light therapy is a non-invasive and non-laser light treatment that is FDA-approved for various conditions in dermatology. Subjects will receive a total of 4 treatments over the course of the study, at intervals of 2 weeks. Each treatment will include applications on 10-15 IPL pulses in the malar region and close to the lower eyelids, followed by meibomian gland expression. Meibomian gland expression will be implemented by squeezing the meibomian glands with the aid of two Q-tips positioned on either side of the meibomian glands, or with a meibomian gland expressor forceps.

Intervention Type: DEVICE

Sham therapy

Subjects will receive a total of 4 treatments over the course of the study, at intervals of 2 weeks. Each treatment will include a sham application of IPL on 10-15 locations in the malar region and close to the lower eyelids, followed by meibomian gland expression. Meibomian gland expression will be implemented by squeezing the meibomian glands with the aid of two Q-tips positioned on either side of the meibomian glands, or with a meibomian gland expressor forceps.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Subject is able to read, understand and sign an Informed Consent (IC) form

2. Subject is 18 years or older

3. Subject has Fitzpatrick skin type I to IV

4. SPEED questionnaire equal or more than 10

5. OSDI questionnaire equal or more than 23

6. In both eyes, at least 5 non-atrophied meibomian glands on the lower eyelid.

7. In both eyes, Tear break up time equal or less than 7 seconds

8. In both eyes, MGA (the total meibomian gland score for 15 glands of the lower eyelid) is smaller or equal to 12

Exclusion Criteria

1. Contact lens wear within the month prior to screening

2. Unwilling to discontinue use of contact lenses for the duration of the study

3. Ocular surgery or eyelid surgery within 6 months prior to screening

4. Neuro-paralysis in the planned treatment area within 6 months prior to screening

5. Other uncontrolled eye disorders affecting the ocular surface, for example active allergies

6. Current use of punctal plugs

7. Pre-cancerous lesions, skin cancer or pigmented lesions in the planned treatment area

8. Uncontrolled infections or uncontrolled immunosuppressive diseases

9. Subjects with ocular infections within 6 months prior to screening

10. Prior history of cold sores or rashes in the perioral area or in the planned treatment area that could be stimulated by light at a wavelength of 560 nm to 1200 nm (e.g., Herpes simplex 1 & 2, Systemic Lupus erythematosus, porphyria)

11. Use of photosensitive medication and/or herbs that may cause sensitivity to 560-1200 nm light exposure, such as Isotretinoin, Tetracycline, Doxycycline, or St. John's Wort within 3 months prior to screening

12. Over exposure to sun within 4 weeks prior to screening, in the judgment of the investigator

13. Administration of prescription eye drops for dry eye within 7 days prior to screening, excluding artificial tears and glaucoma drops

14. Radiation therapy to the head or neck within 12 months prior to screening, or planned radiation therapy within 8 weeks after completion of all IPL treatments

15. Treatment with chemotherapeutic agent within 8 weeks prior to screening, 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 3 months prior to screening, except over-the-counter acetaminophen-based analgesics (such as Extra Strength Tylenol®) for pain management after study treatment, new oral omega 3 fatty acid supplements and topical artificial tears

17. Change in dosage of any systemic medication within 3 months prior to screening

18. Anticipated relocation or extensive travel outside of the local study area preventing compliance with follow-up over the study period

19. Legally blind in either or both eyes

20. History of migraines, seizures or epilepsy

21. IPL treatment within 12 months prior to screening

22. Lipiflow treatment, or any other thermal treatment of the eyelids, within 6 months prior to screening

23. Expression of the meibomian glands within 6 months prior to screening

24. Any condition revealed during the eligibility screening process whereby the investigator deems the subject inappropriate for this study

25. Women below the age of menopause (50 years of age)

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

Sponsors

Lumenis Be Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Zadok, MD

Role: PRINCIPAL_INVESTIGATOR

Shaarei Zedek Hospital ( Jerusalem)

Locations

Shaare Zedek

Jerusalem, , Israel

Countries

Israel

Other Identifiers

0171-17-SZMC

Identifier Type: OTHER

Identifier Source: secondary_id

LUM-VBU-IPL-M22-17-02

Identifier Type: -

Identifier Source: org_study_id