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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03012698
Other study ID # CA-10002
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


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
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