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

NCT05741398 | Unknown DMC

• 1 other identifier: CLN 0100
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Dry Eye Syndromes

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• OSDI changes from baseline to 4 and 12 weeks FU

  up to 12 weeks post last treatment

• 12 weeks TBUT change from baseline

  12 weeks post last treatment

Study Arms (1)

Demaod VR system tratment

EXPERIMENTAL

Non-invasive light pulse generated by a non-contacting device for treating the symptoms of dry eyes and MDG.

Device: VR system by Demaod

Interventions

VR system by Demaod DEVICE

non-invasive light pulse generated by a non-contacting device for the treatment of the symptoms of dry eyes and MDG

Demaod VR system tratment

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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:

Sponsors & Collaborators

• Demaod Ltd: lead

Study Sites (1)

Haemek Medical Center

Afula, 3824674, Israel

RECRUITING

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Central Study Contacts

Hila Kfir, b.sc

CONTACT

0523313350; Kfirclinical@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: no masking during this study.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single-center, Prospective, Open Label, with Before-After Study Design

Study Record Dates

• First Submitted: February 14, 2023
• First Posted: February 23, 2023
• Study Start: June 1, 2023
• Primary Completion: November 1, 2023
• Study Completion: December 30, 2023
• Last Updated: June 27, 2023

Record last verified: 2023-02

Locations

IL (1)