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

Primary Purpose

Dry Eye Syndromes

Status
Recruiting
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
VR system by Demaod
Sponsored by
Demaod Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dry Eye Syndromes

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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: -

Sites / Locations

  • Haemek Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Demaod VR system tratment

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
February 14, 2023
Last Updated
June 25, 2023
Sponsor
Demaod Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT05741398
Brief Title
Evaluation of Optical System in the Treatment of - Dry Eye Disease
Official Title
Evaluation of the Efficacy and Safety of Optical System in the Treatment of - Dry Eye Disease (DED) Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2023 (Actual)
Primary Completion Date
November 1, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Demaod Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Syndromes

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single-center, Prospective, Open Label, with Before-After Study Design
Masking
None (Open Label)
Masking Description
no masking during this study.
Allocation
N/A
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Demaod VR system tratment
Arm Type
Experimental
Arm Description
Non-invasive light pulse generated by a non-contacting device for treating the symptoms of dry eyes and MDG.
Intervention Type
Device
Intervention Name(s)
VR system by Demaod
Intervention Description
non-invasive light pulse generated by a non-contacting device for the treatment of the symptoms of dry eyes and MDG
Primary Outcome Measure Information:
Title
4 weeks TBUT change from baseline
Description
Change from baseline to the 4-week follow-up exam in Tear Break Up Times (TBUT), as assessed by a rater.
Time Frame
up to 4 weeks post last treatment
Secondary Outcome Measure Information:
Title
OSDI changes from baseline to 4 and 12 weeks FU
Description
Change from baseline in patient symptoms using Ocular Surface Disease Index (OSDI) at 4-weeks and 12-weeks follow-up exam.
Time Frame
up to 12 weeks post last treatment
Title
12 weeks TBUT change from baseline
Description
Changes from baseline to the 12-week follow-up exam in Tear Break Up Times (TBUT), as assessed by a rater.
Time Frame
12 weeks post last treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
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: -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hila Kfir, b.sc
Phone
0523313350
Email
Kfirclinical@gmail.com
Facility Information:
Facility Name
Haemek Medical Center
City
Afula
ZIP/Postal Code
3824674
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel Briscoe, MD
Phone
050-4439421
Email
dr.danielbriscoe@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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