Dry Eye Syndromes
Conditions
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).
Interventions
DEVICEVR system by Demaod
non-invasive light pulse generated by a non-contacting device for the treatment of the symptoms of dry eyes and MDG
Sponsors
Demaod Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
no masking during this study.
Intervention model description
Single-center, Prospective, Open Label, with Before-After Study Design
Eligibility
Sex/Gender
ALL
Age
18 Years to 120 Years
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: \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
Israel
Contacts
Primary ContactHila Kfir, b.sc
Outcome results
None listed