Pilot Study for Testing Safety of Repetitive Magnetic Stimulation for Treatment of Dry Eye

Dry Eye Clinical Trial

Official title:

Pilot Study for Testing Safety of Repetitive Magnetic Stimulation for Treatment of Dry Eye

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03012698
• Other study ID #: CA-10002
• Status: Completed
• Phase: N/A
• Start date: November 1, 2017
• Est. completion date: June 17, 2019

Study information

• Verified date: November 2019
• Source: Epitech Mag Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study aims to test the safety of Repetitive Magnetic Stimulation (RMS) treatment for dry eye disease. Patients are asked to undergo a one-time treatment with Epitech Ocular Magnetic Stimulation Device on one eye in the first stage and both eyes sequentially in the second stage of the study. Changes are monitored for over a study period of 3 months.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: June 17, 2019
• Est. primary completion date: June 17, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Males and females, 18-80 years old

2. Subjects with moderate to severe dry eye syndrome

3. Subjects able to understand the requirements of the protocol and provide informed consent.

Exclusion Criteria:

1. Eyes with other ocular surface pathology which requires more treatment than eye lubricant and conventional eyelid hygiene

2. A concurrent ocular disease including ocular infection or pterygium.

3. Ocular surgery within the previous 6 months and LASIK within the previous 1 year.

4. Any ocular injury or ocular Herpes infection within past 3 months

5. Anticipated necessity to wear contact lens in the duration of the study.

6. Unstable thyroid disorders (Drugs Tx not stable in the last 3 months).

7. Alcoholism

8. Pregnant or nursing women

9. Documented HIV positive

10. Cardiac pacemakers, cardioverter defibrillators, or neurostimulators, cochlear implants, implanted medication pumps or intracardiac lines, implanted brain electrodes (cortical or deep-brain electrodes)

11. Any Conductive, ferromagnetic or other magnetic - sensitive objects such as aneurysm clips or coils, stents, bullet fragments in the head or neck

12. Significant heart disease or cerebrovascular disease

13. History of epilepsy, dementia, head trauma, increased intracranial pressure, or central nervous system (CNS) tumors.

14. Participation in another ophthalmic clinical trial within past 30 day

15. Any other specified reason as determined by the clinical investigator.

Related Conditions & MeSH terms

• Aqueous Tear Deficiency
• Dry Eye
• Dry Eye Syndromes
• Keratoconjunctivitis Sicca
• Meibomian Gland Dysfunction
• Sjogren's Syndrome
• Syndrome

Intervention

Device:
• Ocular Repetitive Magnetic Stimulation (RMS) treatment
First stage: Patients will be asked to undergo a one-time treatment with Epitech Corneal Magnetic Stimulation Device on one eye. The worst eye will be treated; if both eyes are equal, the right eye will be treated. Second stage: will be treated on both eyes, applying treatment to both eyes sequentially during the same visit.

Locations

Country	Name	City	State
Israel	E. Wolfson Medical Center	Holon
Israel	Hadassah Medical Center	Jerusalem
Israel	Shaare Zedek Medical Center (SZMC)	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Epitech Mag Ltd.

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Best Corrected Visual Acuity (BCVA)		3 mounth