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

Sponsor
Demaod Ltd (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05741398
Collaborator
(none)
15
1
9

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: VR system by Demaod
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
15 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Single-center, Prospective, Open Label, with Before-After Study DesignSingle-center, Prospective, Open Label, with Before-After Study Design
Masking:
None (Open Label)
Masking Description:
no masking during this study.
Primary Purpose:
Treatment
Official Title:
Evaluation of the Efficacy and Safety of Optical System in the Treatment of - Dry Eye Disease (DED) Pilot Study
Anticipated Study Start Date :
Apr 1, 2023
Anticipated Primary Completion Date :
Nov 1, 2023
Anticipated Study Completion Date :
Dec 30, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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.

  2. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 120 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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:

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Demaod Ltd

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Demaod Ltd
ClinicalTrials.gov Identifier:
NCT05741398
Other Study ID Numbers:
  • CLN 0100
First Posted:
Feb 23, 2023
Last Update Posted:
Feb 24, 2023
Last Verified:
Feb 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 24, 2023