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
Verified date | February 2023 |
Source | Demaod Ltd |
Contact | Hila Kfir, b.sc |
Phone | 0523313350 |
Kfirclinical[@]gmail.com | |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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: - |
Country | Name | City | State |
---|---|---|---|
Israel | Haemek Medical Center | Afula |
Lead Sponsor | Collaborator |
---|---|
Demaod Ltd |
Israel,
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 |
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