NCT05741398

Evaluation of Optical System in the Treatment of - Dry Eye Disease

Evaluation of the Efficacy and Safety of Optical System in the Treatment of - Dry Eye Disease (DED) Pilot Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Demaod Ltd · Industry
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

Summary

Single-center, Prospective, Open Label, with Before-After Study Design, to evaluate the safety and efficacy of the optical system in the treatment of dry eye disease.

Detailed description

Single-center, Prospective, Open Label, with Before-After Study Design. Up to 15 subjects will be enrolled in the study to provide at least 10 evaluable subjects. All subjects will undergo 3 treatments two weeks apart (2 weeks (+/-3 days) from the previous treatment). Follow-up visits after the last treatment visit: 4 weeks (±7 days), 12 weeks (±7 days).

Conditions

• Dry Eye Syndromes

Interventions

Type	Name	Description
DEVICE	VR system by Demaod	non-invasive light pulse generated by a non-contacting device for the treatment of the symptoms of dry eyes and MDG

Timeline

• Start date: 2023-06-01
• Primary completion: 2023-11-01
• Completion: 2023-12-30
• First posted: 2023-02-23
• Last updated: 2023-06-27

Locations

1 site across 1 country: Israel