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Not Yet Recruiting NCT05741398

EFFICACY AND SAFETY OF OPTICAL SYSTEM IN THE TREATMENT OF - DRY EYE DISEASE

Conditions: Dry Eye Syndromes

Sex: All
Ages: 18 Years – 120 Years
Phase: NA
Enrollment: 15
Sponsor: Demaod Ltd

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.

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:-

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05741398). StuddyBuddy aggregates publicly available trial information.