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

Not Applicable

Recruiting

• Conditions: Dry Eye Syndromes
• Interventions: Device: VR system by Demaod

• Registration Number: NCT05741398
• Lead Sponsor: Demaod Ltd

Brief 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).

Study Timeline

• Status Verified: 2023-02
• Study First Submitted: 2023-02-14
• Study First Submitted QC: 2023-02-14
• Study First Posted: 2023-02-23
• Study Start: 2023-06-01
• Last Update Submitted: 2023-06-25
• Last Update Posted: 2023-06-27
• Primary Completion: 2023-11-01
• Study Completion: 2023-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• Age 18 years and older of any gender or race.
• Provide written informed consent before study participation.
• Willingness and ability to return for all study visits.
• Ocular Surface Disease Index (OSDI) questionnaire and a score of ≥ 23 at the baseline visit.
• Tear break-up time (TBUT) <10 seconds in both eyes.
• Agreement/ability to abstain from dry eye/MGD medications for the time between the treatment visit/s and the final study visit. Ocular lubricants are allowed if no changes are made during the study.

Exclusion:

• History of ocular surgery including intraocular, oculoplastic, corneal or refractive surgery within 1 year.
• Patients with giant papillary conjunctivitis.
• Patients with punctal plugs or who have had punctal cautery.
• Ocular injury or trauma, chemical burns, or limbal stem cell deficiency within 3 months of the baseline examination.
• Active ocular herpes zoster or simplex of eye or eyelid or a history of these within the last 3 months.
• Aphakic Patients.
• Cicatricial lid margin disease identified via slit lamp examination, including pemphigoid, symblepharon, etc.
• Active ocular infection (e.g., viral, bacterial, mycobacterial, protozoan, or fungal infection of the cornea, conjunctiva, lacrimal gland, lacrimal sac, or eyelids including a hordeolum or stye).
• Active ocular inflammation or history of chronic, recurrent ocular inflammation within 3 months (e.g., retinitis, macular inflammation, choroiditis, uveitis, iritis, scleritis, episcleritis, keratitis).

Criteria:

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Demaod VR system tratment	VR system by Demaod	Non-invasive light pulse generated by a non-contacting device for treating the symptoms of dry eyes and MDG.

Primary Outcome Measures

Name	Time	Method
4 weeks TBUT change from baseline	up to 4 weeks post last treatment	Change from baseline to the 4-week follow-up exam in Tear Break Up Times (TBUT), as assessed by a rater.

Secondary Outcome Measures

Name	Time	Method
OSDI changes from baseline to 4 and 12 weeks FU	up to 12 weeks post last treatment	Change from baseline in patient symptoms using Ocular Surface Disease Index (OSDI) at 4-weeks and 12-weeks follow-up exam.
12 weeks TBUT change from baseline	12 weeks post last treatment	Changes from baseline to the 12-week follow-up exam in Tear Break Up Times (TBUT), as assessed by a rater.

Trial Locations

Locations (1)

Haemek Medical Center; 🇮🇱 Afula, Israel