[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100645148":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":29,"centralContacts":33,"locations":39,"responsibleParty":128,"collaborators":37,"id":131,"slug":37,"hasResults":132,"nctId":133,"briefTitle":134,"officialTitle":135,"acronym":37,"eligibilityCriteria":136,"healthyVolunteers":132,"sex":137,"minAge":138,"maxAge":139,"enrollmentInfo":140,"targetDuration":37,"studyType":143,"phases":144,"briefSummary":146,"conditions":147,"keywords":149,"overallStatus":152,"whyStopped":37,"lastUpdateSubmitDate":153,"lastUpdatePostDateStruct":154,"startDateStruct":157,"completionDateStruct":159,"leadSponsor":161,"locationsCount":162},{"fullName":5,"class":6},"Beijing Tongren Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"0.1% Sodium Hyaluronate Eye Drops","ACTIVE_COMPARATOR","1 drop per eye, 4 times daily (3-5 hour intervals between doses), applied bilaterally to the lower conjunctival sac, for 8 weeks.",[13],"Drug: 0.1% Sodium Hyaluronate Eye Drops",{"label":15,"type":16,"description":11,"interventionNames":17},"Perfluorohexyloctane Eye Drops (PFHO)","EXPERIMENTAL",[18],"Drug: Perfluorohexyloctane Eye Drops (PFHO)",[20,25],{"type":21,"name":9,"description":11,"armGroupLabels":22,"otherNames":23},"DRUG",[9],[24],"Hialid®，Santen Pharmaceutical(China) Co., Ltd",{"type":21,"name":15,"description":11,"armGroupLabels":26,"otherNames":27},[15],[28],"Hengqin®, Chengdu Shengdi Pharmaceutical Co., Ltd.",[30],{"name":31,"affiliation":5,"role":32},"Jin Yuan","PRINCIPAL_INVESTIGATOR",[34],{"name":31,"role":35,"phone":36,"phoneExt":37,"email":38},"CONTACT","010-58366699",null,"yuanjincornea@126.com",[40,55,60,68,76,87,95,106,117],{"facility":41,"status":37,"city":42,"state":43,"zip":37,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Beijing Anzhen Hospital","Beijing","Beijing Municipality","China","CN",{"type":47,"coordinates":48},"Point",[49,50],116.39723,39.9075,{"lat":50,"lon":49},[53],{"name":54,"role":35,"phone":37,"phoneExt":37,"email":37},"Xinxiao Gao",{"facility":56,"status":37,"city":42,"state":37,"zip":37,"country":44,"countryCode":45,"cosmosGeoPoint":57,"geoPoint":59,"contacts":37},"Beijing Aier-Intech Eye Hospital",{"type":47,"coordinates":58},[49,50],{"lat":50,"lon":49},{"facility":61,"status":37,"city":42,"state":37,"zip":37,"country":44,"countryCode":45,"cosmosGeoPoint":62,"geoPoint":64,"contacts":65},"Chinese PLA General Hospital",{"type":47,"coordinates":63},[49,50],{"lat":50,"lon":49},[66],{"name":67,"role":35,"phone":37,"phoneExt":37,"email":37},"Liqiang Wang",{"facility":69,"status":37,"city":42,"state":37,"zip":37,"country":44,"countryCode":45,"cosmosGeoPoint":70,"geoPoint":72,"contacts":73},"Peking Union Medical College Hospital",{"type":47,"coordinates":71},[49,50],{"lat":50,"lon":49},[74],{"name":75,"role":35,"phone":37,"phoneExt":37,"email":37},"Di Chen",{"facility":77,"status":37,"city":78,"state":37,"zip":37,"country":44,"countryCode":45,"cosmosGeoPoint":79,"geoPoint":83,"contacts":84},"Guangdong Provincial People's Hospital","Guangzhou",{"type":47,"coordinates":80},[81,82],113.25,23.11667,{"lat":82,"lon":81},[85],{"name":86,"role":35,"phone":37,"phoneExt":37,"email":37},"Honghua Yu",{"facility":88,"status":37,"city":78,"state":37,"zip":37,"country":44,"countryCode":45,"cosmosGeoPoint":89,"geoPoint":91,"contacts":92},"Sun Yat-sen Memorial Hospital",{"type":47,"coordinates":90},[81,82],{"lat":82,"lon":81},[93],{"name":94,"role":35,"phone":37,"phoneExt":37,"email":37},"Yuqing Lan",{"facility":96,"status":37,"city":97,"state":37,"zip":37,"country":44,"countryCode":45,"cosmosGeoPoint":98,"geoPoint":102,"contacts":103},"Eye & ENT Hospital of Fudan University","Shanghai",{"type":47,"coordinates":99},[100,101],121.45806,31.22222,{"lat":101,"lon":100},[104],{"name":105,"role":35,"phone":37,"phoneExt":37,"email":37},"Lan Gong",{"facility":107,"status":37,"city":108,"state":37,"zip":37,"country":44,"countryCode":45,"cosmosGeoPoint":109,"geoPoint":113,"contacts":114},"Xi'an Fourth Hospital","Xi'an",{"type":47,"coordinates":110},[111,112],108.92861,34.25833,{"lat":112,"lon":111},[115],{"name":116,"role":35,"phone":37,"phoneExt":37,"email":37},"Ying Li",{"facility":118,"status":37,"city":119,"state":37,"zip":37,"country":44,"countryCode":45,"cosmosGeoPoint":120,"geoPoint":124,"contacts":125},"Zhongshan City People's Hospital","Zhongshan",{"type":47,"coordinates":121},[122,123],113.37912,22.52306,{"lat":123,"lon":122},[126],{"name":127,"role":35,"phone":37,"phoneExt":37,"email":37},"Naiyang Li",{"type":32,"investigatorFullName":129,"investigatorTitle":130,"investigatorAffiliation":5,"oldNameTitle":37,"oldOrganization":37},"Jinyuan,MD","President of Beijing Tongren Hospital","100645148",false,"NCT07679685","Perfluorohexyloctane Eye Drops vs. Sodium Hyaluronate for Video Display Terminal-Associated Dry Eye","A Prospective, Multicenter, Randomized Controlled Trial on the Efficacy and Safety of Perfluorohexyloctane Eye Drops Versus 0.1% Sodium Hyaluronate Eye Drops in the Treatment of Video Display Terminal-associated Dry Eye","Inclusion Criteria:\n\n1. Age 18-70 years (inclusive), male or female;\n2. Subject reports dry eye symptoms for at least 6 months;\n3. Diagnosis of mild to moderate dry eye according to the Chinese Dry Eye Expert Consensus (2020) criteria:\n\n   * Mild dry eye: fluorescein tear film break-up time (FBUT) ≥2 seconds, no significant ocular surface damage signs, corneal fluorescein staining score \\\u003C5;\n   * Moderate dry eye: FBUT ≥2 seconds AND corneal fluorescein staining dots \\\u003C30 or not exceeding 2 quadrants;\n4. Normal tear secretion: Schirmer I test ≥10 mm\u002F5 min;\n5. Daily electronic screen usage \\>6 hours;\n6. Electronic screen use for at least 5 days\u002Fweek, for more than 1 year;\n7. Understands and provides written informed consent.\n\nExclusion Criteria:\n\n1. Allergy or hypersensitivity to any component of the study drugs;\n2. Requires the use of artificial tears (other than study drug), secretagogues, ocular surface repair agents, anti-inflammatory\u002Fantibiotic eye drops, or other dry eye-related drugs (e.g., muscarinic receptor blockers for visual fatigue) during the study period;\n3. Presence of any of the following ocular or systemic conditions:\n\n   * Active ocular infection, ocular inflammation, or active ocular allergy;\n   * Conjunctivochalasis, nasolacrimal duct obstruction;\n   * Glaucoma or elevated intraocular pressure;\n   * Retinal disease or ocular tumor;\n   * Requirement to wear contact lenses during the study;\n   * Obstructive sleep apnea syndrome or sleep disorders;\n   * Planned or ongoing physical therapy (intense pulsed light, meibomian gland massage, warm compress, thermopulsation) within 2 weeks before enrollment through the end of study;\n4. Ocular surgery within 3 months prior to enrollment, incomplete recovery from previous ocular surgery, or planned ophthalmic surgery during the study period;\n5. Current smoker;\n6. Pregnant or breastfeeding women, or women planning to become pregnant during the study period;\n7. Uncontrolled systemic disease, or use of systemic medications (e.g., beta-blockers, benzodiazepines, corticosteroids, antihistamines, or other medications that may interfere with tear production);\n8. History of anxiety or depression;\n9. Any other condition that, in the judgment of the investigator, would make the subject unsuitable for participation.","ALL","18 Years","70 Years",{"count":141,"type":142},159,"ESTIMATED","INTERVENTIONAL",[145],"PHASE4","This is a prospective, multicenter, open-label, randomized controlled trial designed to evaluate the efficacy and safety of perfluorohexyloctane (PFHO) eye drops (Hengqin®, Chengdu Shengdi Pharmaceutical Co., Ltd.) compared with 0.1% sodium hyaluronate eye drops in patients with video display terminal (VDT)-associated dry eye.\n\nParticipants aged 18-70 years with mild to moderate dry eye (confirmed by Chinese Dry Eye Expert Consensus 2020 criteria) who use video display terminal for more than 6 hours\u002Fday and at least 5 days\u002Fweek for more than 1 year will be enrolled. A total of 159 subjects will be randomized in a 2:1 ratio to the experimental group (PFHO eye drops, n=106) or control group (0.1% sodium hyaluronate eye drops, n=53), both administered 1 drop\u002Feye, 4 times daily (3-5 hour intervals), bilaterally, for 8 weeks.\n\nThe primary endpoint is the change from baseline in fluorescein tear film break-up time (FBUT) at Week 8. Secondary endpoints include FBUT changes at Weeks 2 and 4, standard patient evaluation of eye dryness（SPEED） questionnaire score changes, total corneal fluorescein staining (tCFS), partial blink rate (PBR), non-invasive tear film break-up time (NIBUT), lipid layer thickness (LLT), meibomian gland secretion quality score, and This is a prospective, multicenter, open-label, randomized controlled trial designed to evaluate the efficacy and safety of perfluorohexyloctane (PFHO) eye drops (Hengqin®, Chengdu Shengdi Pharmaceutical Co., Ltd.) compared with 0.1% sodium hyaluronate eye drops (Hialid®) in patients with video display terminal (VDT)-associated dry eye.\n\nParticipants aged 18-70 years with mild to moderate dry eye (confirmed by Chinese Dry Eye Expert Consensus 2020 criteria) who use electronic screens for more than 6 hours\u002Fday and at least 5 days\u002Fweek for more than 1 year will be enrolled. A total of 159 subjects will be randomized in a 2:1 ratio to the experimental group (PFHO eye drops, n=106) or control group (0.1% sodium hyaluronate eye drops, n=53), both administered 1 drop\u002Feye, 4 times daily (3-5 hour intervals), bilaterally, for 8 weeks.\n\nThe primary endpoint is the change from baseline in fluorescein tear film break-up time (FBUT) at Week 8. Secondary endpoints include FBUT changes at Weeks 2 and 4, SPEED questionnaire score changes, total corneal fluorescein staining (tCFS), partial blink rate (PBR), non-invasive tear film break-up time (NIBUT), lipid layer thickness (LLT), meibomian gland secretion quality score, and meibography score at Weeks 2, 4, and 8.",[148],"Dry Eye",[150,151],"Dry eye","video display terminal","NOT_YET_RECRUITING","2026-06-29",{"date":155,"type":156},"2026-07-01","ACTUAL",{"date":158,"type":142},"2026-06-30",{"date":160,"type":142},"2027-04-30",{"name":5,"class":6},9]