Clinical trial NCT05741398: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Dry Eye Syndromes
Lead sponsor: Demaod Ltd
Sponsor class: INDUSTRY
First posted: 2023-02-23
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single-center, Prospective, Open Label, with Before-After Study Design
Primary purpose: TREATMENT

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).

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:

-

Primary outcomes:
measure: 4 weeks TBUT change from baseline
timeFrame: up to 4 weeks post last treatment
Secondary outcomes:
measure: OSDI changes from baseline to 4 and 12 weeks FU
timeFrame: up to 12 weeks post last treatment
measure: 12 weeks TBUT change from baseline
timeFrame: 12 weeks post last treatment
Other outcomes:
Locations:
city: Afula
country: Israel
facility: Haemek Medical Center
Study officials:
References: