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

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.

Study Overview

• Status: Recruiting
• Conditions: Dry Eye Syndromes
• Intervention / Treatment: Device: VR system by Demaod

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 Type: Interventional
• Enrollment (Estimated): 15
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hila Kfir, b.sc; Phone Number: 0523313350; Email: Kfirclinical@gmail.com

Study Locations

• Israel
  • Afula, Israel, 3824674
    • Recruiting
    • HaEmek Medical Center
    • Contact: Daniel Briscoe, MD; Phone Number: 050-4439421; Email: dr.danielbriscoe@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 120 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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:

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Demaod VR system tratment; Non-invasive light pulse generated by a non-contacting device for treating the symptoms of dry eyes and MDG.	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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Demaod Ltd

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2023
• Primary Completion (Estimated): November 1, 2023
• Study Completion (Estimated): December 30, 2023

Study Registration Dates

• First Submitted: February 14, 2023
• First Submitted That Met QC Criteria: February 14, 2023
• First Posted (Actual): February 23, 2023

Study Record Updates

• Last Update Posted (Actual): June 27, 2023
• Last Update Submitted That Met QC Criteria: June 25, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Eye Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca
• Other Study ID Numbers: CLN 0100

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No