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

Dry Eye Syndromes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05741398
• Other study ID #: CLN 0100
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2023
• Est. completion date: December 30, 2023

Study information

• Verified date: February 2023
• Source: Demaod Ltd
• Contact: Hila Kfir, b.sc
• Phone: 0523313350
• Email: Kfirclinical[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: December 30, 2023
• Est. primary completion date: November 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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: -

Related Conditions & MeSH terms

• Dry Eye Syndromes
• Eye Diseases
• Keratoconjunctivitis Sicca

Intervention

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

Locations

Country	Name	City	State
Israel	Haemek Medical Center	Afula

Sponsors (1)

Lead Sponsor	Collaborator
Demaod Ltd

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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