Evaluation of Optical System in the Treatment of - Dry Eye Disease
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 |
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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
Arms and Interventions
Arm | Intervention/Treatment |
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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
- 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
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age 18 years and older of any gender or race.
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Provide written informed consent before study participation.
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Willingness and ability to return for all study visits.
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Ocular Surface Disease Index (OSDI) questionnaire and a score of ≥ 23 at the baseline visit.
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Tear break-up time (TBUT) <10 seconds in both eyes.
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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:
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History of ocular surgery including intraocular, oculoplastic, corneal or refractive surgery within 1 year.
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Patients with giant papillary conjunctivitis.
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Patients with punctal plugs or who have had punctal cautery.
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Ocular injury or trauma, chemical burns, or limbal stem cell deficiency within 3 months of the baseline examination.
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Active ocular herpes zoster or simplex of eye or eyelid or a history of these within the last 3 months.
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Aphakic Patients.
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Cicatricial lid margin disease identified via slit lamp examination, including pemphigoid, symblepharon, etc.
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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).
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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.- CLN 0100