[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"glaucoma-open-angle-primary\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:glaucoma-open-angle-primary":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,41,77],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100644454","phase-3-kj-tfc-005-phase-3-study-evaluate-the-efficacy-and-safety-of-tfc-003-in-patients-with-primary-open-angle-glaucoma-or-ocular-hypertension-100644454",false,"NCT07662759","[KJ-TFC-005] Phase 3 Study, Evaluate the Efficacy and Safety of TFC-003 in Patients With Primary Open-Angle Glaucoma or Ocular Hypertension","A Prospective, Multicenter, Randomized, Investigator-Masked, Active-Controlled, Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of TFC-003 in Patients With Primary Open-Angle Glaucoma or Ocular Hypertension","Inclusion Criteria:\n\n1. Male or female adults aged ≥19 years at the time of informed consent.\n2. Diagnosis of primary open-angle glaucoma or ocular hypertension.\n3. At the screening visit, subjects who meet any of the following:\n\n   * history of or current use of triple therapy, or\n   * history of or current use of dual therapy (dorzolamide and a topical beta-blocker), or\n   * inadequate IOP control despite current treatment, and who, in the investigator's judgment, have not achieved target IOP based on the degree of optic nerve damage and may benefit from additional IOP reduction with triple therapy.\n4. Completion of an appropriate washout period for prior glaucoma medications before the randomization visit (based on the longest washout period among the components of prior medications):\n\n   \\- Parasympathomimetics, oral or topical carbonic anhydrase inhibitors: 5 days\n\n   \\- α-agonists: 14 days (brimonidine: 28 days)\n   * β-antagonists, prostaglandin analogues: 28 days\n   * Rho-kinase inhibitors: 28 days\n5. Mean intraocular pressure (IOP) ≥21 mmHg in either eye at 8:30 AM (±1 hour) at the randomization visit (same eye as the study eye).\n6. Ability to understand and voluntarily sign the informed consent form.\n\nExclusion Criteria:\n\n1\\. Subjects with any of the following comorbidities or conditions:\n\n1. Central visual field defect with mean deviation (MD) ≤ -25 dB on visual field testing.\n2. Chronic, recurrent, or severe inflammatory ocular disease (e.g., scleritis, uveitis, or herpetic keratitis).\n3. Best-corrected visual acuity (BCVA) \\\u003C 0.25 (Han Chun Suk visual acuity chart) at both screening and randomization visits.\n4. Any condition that prevents reliable intraocular pressure (IOP) measurement.\n5. Other ocular pathology that, in the investigator's opinion, precludes use of the investigational product (e.g., severe dry eye).\n6. Conditions requiring additional topical or systemic IOP-lowering medications during the study.\n7. Reactive airway disease, including bronchial asthma or history thereof, bronchospasm, or severe chronic obstructive pulmonary disease.\n8. Sinus bradycardia, second- or third-degree atrioventricular block, overt heart failure, cardiogenic shock, sick sinus syndrome, or sinoatrial block.\n9. Severe renal impairment (creatinine clearance \\\u003C30 mL\u002Fmin) or hyperchloremic acidosis.\n10. Untreated pheochromocytoma.\n11. Any severe disease that, in the investigator's judgment, renders the subject unsuitable for the study.\n\n2\\. History of the following conditions or procedures (including surgery):\n\n1. Ocular trauma or ocular surgery within 24 weeks prior to screening (cataract surgery performed \\>8 weeks prior is not excluded).\n2. Ocular infection or ocular inflammation within 12 weeks prior to screening (within 8 weeks for simple conjunctivitis).\n3. Ocular laser surgery within 12 weeks prior to screening.\n\n3\\. Prior or concomitant medications:\n\n1. Oral beta-blockers within 4 weeks prior to randomization.\n2. Addition of antihypertensive agents that may affect IOP within 4 weeks prior to randomization (excluding beta-blockers; e.g., calcium channel blockers, ACE inhibitors), unless the regimen has been stable for at least 7 days prior to screening.\n3. α-adrenergic agonists, MAO inhibitors, or antidepressants affecting norepinephrine transmission within 2 weeks prior to randomization.\n4. Topical ocular or periocular corticosteroids within 2 weeks prior to randomization.\n5. Systemic corticosteroids within 4 weeks prior to randomization.\n6. Intravitreal or sub-Tenon corticosteroid injection within 24 weeks prior to randomization.\n\n4\\. Subjects requiring contact lens use during the study period. 5. Known hypersensitivity, in the investigator's opinion, to any component of the investigational product or ophthalmic diagnostic eye drops.\n\n6\\. Use of any investigational drug or device within 4 weeks prior to screening (subjects participating in non-interventional studies such as observational studies or PMS may be enrolled).\n\n7\\. Pregnant or breastfeeding women. 8. Women and men of childbearing potential who are unwilling to use medically acceptable contraception or who plan pregnancy during the study period.\n\nAcceptable contraception methods:\n\nHormonal contraceptives (oral, injectable, implantable, etc.) Intrauterine device (IUD) or intrauterine system (IUS) Surgical sterilization (e.g., vasectomy, hysterectomy, bilateral oophorectomy, bilateral salpingectomy) Sexual abstinence (only absolute abstinence is acceptable; periodic abstinence methods such as calendar, basal body temperature, ovulation methods, withdrawal, or barrier methods are not acceptable unless investigator-deemed strict abstinence is appropriate based on age, occupation, lifestyle, or sexual orientation)","ALL","19 Years",{"count":19,"type":20},188,"ESTIMATED","INTERVENTIONAL",[23],"PHASE3","\\[KJ-TFC-005\\] Phase 3 Study, Evaluate the Efficacy and Safety of TFC-003 in Patients With Primary Open-Angle Glaucoma or Ocular Hypertension",[26,27],"Glaucoma Open-Angle Primary","Ocular Hypertension","RECRUITING","2026-06-17",{"date":31,"type":32},"2026-06-23","ACTUAL",{"date":34,"type":32},"2025-12-09",{"date":36,"type":20},"2027-06",{"name":38,"class":39},"Kukje Pharma","OTHER",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":16,"minAge":49,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":21,"phases":52,"briefSummary":54,"conditions":55,"keywords":58,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":40},"100624744","the-acute-effect-of-exercise-type-and-timing-on-ambulatory-blood-pressure-and-intra-ocular-pressure-in-individuals-with-glaucoma-the-achieve-project-100624744","NCT07413614","The Acute Effect of Exercise Type And Timing on Ambulatory Blood Pressure and Intra-Ocular Pressure in Individuals With Glaucoma (The ACHIEVE-project).","The ACHIEVE-project: Advancing Cardiovascular and Ocular Health In Eye Patients. The Acute Effect of Exercise Type And Timing on Ambulatory Blood Pressure and Intra-Ocular Pressure in Individuals With Glaucoma.","ACHIEVE","Inclusion Criteria:\n\n* Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures\n* At least 18 years of age at the time of signing the Informed Consent Form (ICF)\n* Patients with POAG AND \\[elevated BP OR hypertension (Average SBP on office BP and Home BP ≥120 mmHg AND\u002FOR Average DBP on office BP and Home BP ≥70 mmHg 26) with or without the use of anti-hypertensive medication\\]\n* Patients without recent changes in medication and glaucoma care within the past four weeks.\n\nExclusion Criteria:\n\n* Not able to provide informed consent\n* SBP and\u002For DBP are ≥ 150 mmHg and\u002For ≥ 95 mmHg, respectively, on office BP at screening AND on home BP measurement conducted in the week following screening (to identify White Coat Hypertension) to ensure safety. These patients require referral for early treatment.\n* Aberrant cardiopulmonary exercise test (CPET) at screening (Life-threatening arrhythmias, ischemia,…)\n* Unable to perform one or more of the four exercise sessions due to physical and or mental limitations (severe lung disease, musculoskeletal issues, unstable angina,…)\n* Severe osteoarthritis pending knee replacement surgery (these patients may be unable to perform the IRE (i.e. wall squat exercise)\n* Unable to communicate in Dutch\n* Active malignancy\n* Participation in an interventional Trial with an investigational medicinal product (IMP), exercise intervention or device\n* Unwillingness to repeat ABPM\n* Relative contraindications to ABPM: diagnosed atrial fibrillation, nighttime workers, occupational drivers","18 Years",{"count":51,"type":20},60,[53],"NA","ACHIEVE aims to determine whether exercise can be a safe and effective non-drug approach to improve blood pressure control in patients with primary open-angle glaucoma (POAG). Although exercise is a promising and potentially well-accepted therapy, its use in clinical care is limited because the safety and effectiveness of different exercise types (aerobic, isometric, moderate, or high intensity) and timing (morning versus evening) have not been systematically studied in people with POAG and elevated blood pressure.\n\nThis study will evaluate the safety and short-term effects of different exercise modalities and timings on 24-hour ambulatory blood pressure and blood pressure variability in patients with POAG and elevated blood pressure.\n\nIt is hypothesized that:\n\n* Each exercise session will lead to a temporary reduction in blood pressure (post-exercise hypotension).\n* The greatest and longest-lasting reduction will occur after high-intensity aerobic exercise performed in the morning.\n\nIt is also expected that all exercise types and timings will be safe for participants.",[26,56,57],"Hypertension","Elevated Blood Pressure",[59,60,61,62,63,64,56,65,66],"Ambulatory blood pressure","High intensity interval training","Isometric Exercise","Intra-ocular pressure","Moderate continuous training","Primary open angle glaucoma","Blood pressure variability","Exercise","NOT_YET_RECRUITING","2026-02-09",{"date":70,"type":32},"2026-02-17",{"date":72,"type":20},"2026-04",{"date":74,"type":20},"2027-03",{"name":76,"class":39},"KU Leuven",{"id":78,"slug":79,"hasResults":11,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":83,"eligibilityCriteria":84,"healthyVolunteers":11,"sex":16,"minAge":85,"maxAge":86,"enrollmentInfo":87,"targetDuration":4,"studyType":88,"phases":4,"briefSummary":89,"conditions":90,"keywords":4,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":4},"100609104","glaucoma-diagnostic-and-imaging-analysis-glaudia-study-100609104","NCT07210216","GLAUcoma Diagnostic and Imaging Analysis (GLAUDIA) Study","New Diagnostic Paradigms for the Identification of Early Glaucomatous Damage","GLAUDIA","Inclusion Criteria:\n\n* Age between 40 and 90 years.\n* Best-corrected visual acuity ≥ 0.1 LogMAR (≥ 8\u002F10).\n* For primary open-angle glaucoma (POAG):\n* IOP ≥ 21 mmHg with normal visual field and\u002For normal optic nerve head\u002FRNFL, or\n* Suspicious optic nerve head (excavation), or\n* Reproducible glaucomatous visual field defect.\n* POAG patients stratified by visual field mean deviation (MD): -3 to -10 dB (S1-S2 Brusini classification).\n\nExclusion Criteria:\n\n* Best-corrected visual acuity worse than 0.1 LogMAR (\\\u003C 8\u002F10).\n* Ocular surgery in the last 6 months (except uncomplicated cataract extraction).\n* Previous vitreoretinal surgery for macular pathologies (e.g., macular pucker, macular hole) or retinal detachment.\n* High myopia (\\> -3 diopters).\n* Optic disc anomalies not attributable to glaucoma (tilted disc, papillary drusen, other morphological\u002Ffunctional anomalies).\n* Severe motor disability preventing proper positioning for tests.\n* Cognitive impairment reducing test reliability.","40 Years","90 Years",{"count":51,"type":20},"OBSERVATIONAL","This observational study aims to identify early diagnostic markers of glaucomatous damage by combining functional and structural assessments. Patients with primary open-angle glaucoma and ocular hypertension will undergo comprehensive ophthalmological evaluation, including visual field testing and multimodal imaging of the optic nerve and retina. Both retrospective and prospective data will be collected. The main objective is to define new diagnostic paradigms for detecting early glaucomatous changes and to improve the accuracy of current clinical practice in glaucoma management.",[26,27],"2025-09-29",{"date":93,"type":32},"2025-10-07",{"date":95,"type":20},"2025-10",{"date":97,"type":20},"2028-06",{"name":99,"class":39},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS"]