[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07618364":3,"trial-entities:NCT07618364":78,"trial-summary:NCT07618364":83},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":21,"study_type":24,"primary_purpose":25,"phases":26,"enrollment_info":28,"interventions":31,"primary_outcomes":37,"secondary_outcomes":42,"sex":43,"minimum_age":44,"maximum_age":45,"healthy_volunteers":46,"eligibility_criteria":47,"std_ages":53,"locations":56,"central_contacts":71,"overall_officials":75,"references":76,"see_also_links":77},"NCT07618364","R002a","The Effect of Rinsing on Ocular Inflammation and Symptoms in Patients With Dry Eye Disease","RECRUITING","2027-12-01","2025-06","2026-06-01","2022-01-01","Rinsada","INDUSTRY",false,"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.","The objective is to determine whether irrigation of the bulbar conjunctiva, palpebral conjunctiva, conjunctival fornix, and the corneal surface reduces the inflammatory burden in patients with dry eye disease. The scientific premise is that inflammation contributes to the clinical symptoms of dry eye disease. By reducing the inflammatory mediators on the ocular surface, there may be a reduction in dry eye symptoms.\n\nThe primary endpoint is MMP-9 positivity. Secondary endpoints include CDES-Q, Ocular Itch Scale, and keratometry measurements.\n\nThe study population includes participants who have severe dry eye disease. The inclusion and exclusion criteria is described below. The goal is to recruit 150 patients, Including screen failures, a total of 250 participants will need to be screened for the study.",[18,19,20],"Dry Eye Syndromes","Dry Eye","Ocular Surface Disease",[22,23],"ophthalmology","optometry","INTERVENTIONAL","TREATMENT",[27],"NA",{"count":29,"type":30},33,"ESTIMATED",[32],{"type":33,"name":12,"description":34,"armGroupLabels":35},"DEVICE","Irrigation via irrigating eyelid retractor",[36],"Treatment Eye",[38],{"measure":39,"description":40,"timeFrame":41},"MMP-9 Positivity","Tear MMP-9 levels will be assessed using a point-of-care diagnostic assay. Change from baseline to the specified follow-up visit will be analyzed.","3 Hours",[],"ALL","18 Years",null,true,{"inclusion":48,"exclusion":50,"raw_text":52},[49],"MMP-9 Positivity in both eyes",[51],"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","Inclusion Criteria:\n\n* MMP-9 Positivity in both eyes\n\nExclusion Criteria:\n\n* 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",[54,55],"ADULT","OLDER_ADULT",[57],{"facility":58,"status":7,"city":59,"state":60,"zip":61,"country":62,"contacts":63,"geoPoint":68},"Everett and Hurite Ophthalmic Association","Pittsburgh","Pennsylvania","15219","United States",[64],{"name":65,"role":66,"email":67},"Srinivas Kondapalli, MD","CONTACT","srini@rinsada.com",{"lat":69,"lon":70},40.44062,-79.99589,[72],{"name":73,"role":66,"phone":74,"email":67},"Srinivas S Kondapalli","4123243010",[],[],[],{"nct_id":4,"conditions":79,"biomarkers":81},[80],"Dry Eye Syndrome",[82],"MMP9 Gene",{"nct_id":4,"found":14,"summary":45,"prompt_version":45}]