RecruitingNot ApplicableNCT07618364
The Effect of Rinsing on Ocular Inflammation and Symptoms in Patients With Dry Eye Disease
Sponsor
Rinsada
Enrollment
33 participants
Start Date
Jan 1, 2022
Study Type
INTERVENTIONAL
Conditions
Summary
The central hypothesis is that inflammation contributes to dry eye and that rinsing the palpebral conjunctiva, bulbar conjunctiva, and fornices will reduce the inflammatory burden on the ocular surface.
Eligibility
Min Age: 18 Years
Inclusion Criteria1
- MMP-9 Positivity in both eyes
Exclusion Criteria1
- Active ocular infection, including bacterial, viral, or fungal conjunctivitis Acute allergic conjunctivitis or severe seasonal ocular allergy flare History of autoimmune ocular surface disease (e.g., Sjögren syndrome, ocular cicatricial pemphigoid, Stevens-Johnson syndrome) Current use of topical anti-inflammatory medications, including corticosteroids, cyclosporine, lifitegrast, or topical NSAIDs within 14-30 days prior to enrollment Initiation of new ocular or systemic anti-inflammatory therapy during the study period Contact lens wear within 12-24 hours prior to testing Ocular surgery or laser procedures within the previous 3-6 months Current punctal plug use or punctal occlusion procedures within the prior 3 months Severe aqueous-deficient dry eye preventing adequate tear sample acquisition or reliable InflammaDry testing Use of preserved artificial tears within a specified washout period Eyelid abnormalities or active blepharitis requiring treatment Pregnancy or breastfeeding (optional depending on IRB requirements) History of hypersensitivity to saline irrigation or study materials Any systemic inflammatory disease judged by investigators to confound tear film MMP-9 level
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Interventions
DEVICERinsada
Irrigation via irrigating eyelid retractor
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07618364
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