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

Study Overview
=================
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).

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

Conditions
-----------------
Dry Eye Syndromes

Intervention / Treatment
-----------------
* Device: VR system by Demaod


Participation Criteria
=================
Eligibility Criteria
-----------------
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: -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Single-center, Prospective, Open Label, with Before-After Study Design
Masking: None (Open Label)


Arms and Interventions

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

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 |