[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06542276":3,"trial-entities:NCT06542276":79,"trial-summary:NCT06542276":84},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":37,"secondary_outcomes":42,"sex":43,"minimum_age":44,"maximum_age":45,"healthy_volunteers":46,"eligibility_criteria":47,"std_ages":63,"locations":66,"central_contacts":75,"overall_officials":76,"references":77,"see_also_links":78},"NCT06542276","DunesEye","Single Lipiflow Treatment to Reduce Pharmacologic Burden in DED","Single Vectored Thermal Pulsation Treatment in Patients Using Topical Immunomodulators in the Management of Dry Eye Disease","ENROLLING_BY_INVITATION","2024-09-01","2024-08","2024-08-12","2023-09-01","Dunes Eye Consultants","OTHER",false,"Purpose: To evaluate the efficacy of vectored thermal pulsation treatment in subjects with a history of dry eye disease currently using a topical immunomodulator medication.","Prospective, non-randomized, interventional study. Subjects with bilateral use of a topical immunomodulator drop and a history of dry eye disease were recruited to participate. All subjects underwent a vectored thermal pulsation treatment (LipiFlow). Patients were seen at baseline in a visit immediately prior to treatment and at months 1 and 3 following treatment. Data collected included tear osmolarity, tear break up time (TBUT), tear meniscus height (TMH), meibomian gland function and patient-reported symptoms using the ocular surface disease index (OSDI) questionnaire. Following the 3-month visit, patients were given the option to resume topical immunomodulator therapy.",[19],"MGD-Meibomian Gland Dysfunction",[],"INTERVENTIONAL","TREATMENT",[24],"NA",{"count":26,"type":27},30,"ESTIMATED",[29],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":35},"DEVICE","Thermal Vectored Pulsation","The LipiFlow® (Johnson \\& Johnson Vision, USA) Thermal Pulsation System, also known as vectored thermal pulsation, is a treatment that applies localized heat and pressure to the meibomian glands lining the eyelids. The device consists of a console connected to single-use, sterile devices applied to each eye known as activators. The activator includes an eye warmer with a large lens that gently sits on the conjunctiva of each eye. The activator cups the upper and lower eyelid and applies regulated, outward heat to the surface of the palpebral conjunctiva with an air bladder that intermittently provides directional, controlled massage of the eyelids to promote expression of the liquified contents.",[34],"Lipiflow treatment results",[36],"Lipiflow",[38],{"measure":39,"description":40,"timeFrame":41},"Number of Subjects discontinuing Topical Immunomodulator use","OSDI, TBUT, Tear Osmolarity, Meibomian gland expression quantity, TM","3 months",[],"ALL","25 Years","65 Years",true,{"inclusion":48,"exclusion":52,"raw_text":62},[49,50,51],"No prior history of meibomian gland treatment procedures LipiFlow, TearCare, or I-Lux","lifitegrast or cyclosporine eye drops daily for a period of at least one year but not exceeding five years","Meibograpy documneted retention of at least 50% of meibomian glands.",[53,54,55,56,57,58,59,60,61],"evidence of meibomian gland dropout exceeding 50%","ocular rosacea,","ocular surgery within the preceding three months","prior in-office thermal meibomian gland treatment","ocular trauma within preceding three months","ocular herpetic infection","chronic or recurrent inflammation","eyelid abnormalities affecting lid function ocular surface abnormalities compromising corneal integrity (eg, epithelial basement membrane dystrophy, corneal burn)","pregnant","Inclusion Criteria:\n\n* No prior history of meibomian gland treatment procedures LipiFlow, TearCare, or I-Lux\n* lifitegrast or cyclosporine eye drops daily for a period of at least one year but not exceeding five years\n* Meibograpy documneted retention of at least 50% of meibomian glands.\n\nExclusion Criteria:\n\n* evidence of meibomian gland dropout exceeding 50%\n* ocular rosacea,\n* ocular surgery within the preceding three months\n* prior in-office thermal meibomian gland treatment\n* ocular trauma within preceding three months\n* ocular herpetic infection\n* chronic or recurrent inflammation\n* eyelid abnormalities affecting lid function ocular surface abnormalities compromising corneal integrity (eg, epithelial basement membrane dystrophy, corneal burn)\n* pregnant",[64,65],"ADULT","OLDER_ADULT",[67],{"facility":13,"city":68,"state":69,"zip":70,"country":71,"geoPoint":72},"Dakota Dunes","South Dakota","57049","United States",{"lat":73,"lon":74},42.48749,-96.48642,[],[],[],[],{"nct_id":4,"conditions":80,"biomarkers":83},[81,82],"Dry Eye Syndrome","Meibomian gland dysfunction",[],{"nct_id":4,"found":15,"summary":85,"prompt_version":85},null]