[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07395986":3,"trial-entities:NCT07395986":376,"trial-summary:NCT07395986":380},{"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":19,"study_type":23,"primary_purpose":24,"phases":25,"enrollment_info":27,"interventions":30,"primary_outcomes":40,"secondary_outcomes":61,"sex":69,"minimum_age":70,"maximum_age":16,"healthy_volunteers":14,"eligibility_criteria":71,"std_ages":75,"locations":78,"central_contacts":372,"overall_officials":373,"references":374,"see_also_links":375},"NCT07395986","GOCS-H101-E06","A Multicenter, Randomized, Double-Masked, Placebo-Controlled Pilot Study to Evaluate the Efficacy and Safety of ZOC2017217 in Subjects With Age-Related Cataract","RECRUITING","2027-05","2026-07","2026-07-21","2026-02-10","Ocusun Ophthalmic Pharmaceutical (Guangzhou) Co., Ltd.","INDUSTRY",false,"This is a multicenter, randomized, double-masked, placebo-controlled pilot study conducted in the United States (US) in subjects with age-related cataract in one or both eyes.\n\nApproximately 40 subjects with age-related cataract will be stratified by race and Best Corrected Distance Visual Acuity (BCDVA) and randomized (1:1) to active investigational product (IP) or placebo. Subjects will administer their assigned IP in both eyes, except as noted below, two times a day (BID) for 24 weeks before being exited from the study. Subjects with new or ongoing ocular adverse events (AEs) at the time of planned study exit will be asked to return 2 weeks later for a safety follow-up evaluation.\n\nThe study eye will be the qualified eye that meets study eligibility criteria. Data from the study eye will be used for the purposes of efficacy analyses. Both eyes will receive treatment, except in subjects who have previously undergone cataract surgery in the non-study eye or whose non-study eye, in the opinion of the Investigator, is not suitable for treatment with the IP due to safety or another concern.",null,[18],"Age Related Cataracts",[20,21,22],"Cataract","Cataracts","Age related cataract","INTERVENTIONAL","TREATMENT",[26],"PHASE2",{"count":28,"type":29},40,"ESTIMATED",[31,37],{"type":32,"name":33,"description":34,"armGroupLabels":35},"DRUG","0.4% ZOC2017217","Active Investigational Product",[36],"Active",{"type":32,"name":38,"description":38,"armGroupLabels":39},"Control",[38],[41,45,48,52,55,57,59],{"measure":42,"description":43,"timeFrame":44},"BCDVA","Change from baseline in BCDVA at Weeks 4, 12, and 24.","Baseline as compared to Weeks 4, 12, and 24.",{"measure":46,"description":47,"timeFrame":44},"Contrast Sensitivity","Change from baseline in contrast sensitivity at Weeks 4, 12, and 24.",{"measure":49,"description":50,"timeFrame":51},"Visual Function Questionnaire (VFQ-25)","Change from baseline in Visual Function Questionnaire (VFQ-25) scores at Weeks 4, 12, and 24. VFQ-25 score total should increase from the baseline visit to show better visual function at Weeks 4, 12, and 24.","Baseline compared to Weeks 4, 12, and 24.",{"measure":53,"description":54,"timeFrame":51},"Crystalline Lens Opacity","Change from baseline in crystalline lens opacity at Weeks 4, 12, and 24.",{"measure":42,"description":56,"timeFrame":51},"Proportion of subjects gaining ≥5, ≥10, or ≥15 letters from baseline in BCDVA at Weeks 4, 12, and 24.",{"measure":42,"description":58,"timeFrame":51},"Proportion of subjects losing ≤5, ≤10, or ≤15 letters from baseline in BCDVA at Weeks 4, 12, and 24.",{"measure":42,"description":60,"timeFrame":51},"Proportion of subjects achieving BCDVA ≥0.3, 0.1, or 0.0 Logarithm of the Minimum Angle of Resolution (LogMAR; Snellen: 20\u002F40, 20\u002F25, or 20\u002F20) at Weeks 4, 12, and 24.",[62,66],{"measure":63,"description":64,"timeFrame":65},"Safety, AEs","AE monitoring (ocular and non-ocular)","From the start of use of the IP at Visit 2 (Day 1) to the time the subject is exited after Visit 6 procedures and assessments are conducted. Visit 6 is conducted 2 weeks after the last dose is given at Week 24.",{"measure":67,"description":68,"timeFrame":65},"Safety, Clinically Relevant Changes","Clinically relevant changes from baseline in the following:\n\nVital signs Slit-lamp biomicroscopy Corneal fluorescein staining (CFS)-National Eye Institute (NEI) Grading Scale Corneal endothelial cell count Intraocular pressure (IOP) Dilated fundus examination","ALL","50 Years",{"inclusion":72,"exclusion":73,"raw_text":74},[],[],"Inclusion Criteria:\n\n* Inclusion Criteria:\n\n  1. Are ≥50 years of age.\n  2. Willing and able to provide informed consent and provide relevant privacy authorization(s).\n  3. Willing and able to comply with study requirements and visit schedule.\n  4. Able to successfully administer ophthalmic solution or have an appropriate designee (e.g., family member, health care professional) who can administer ophthalmic solution.\n  5. Have high-contrast BCDVA under photopic conditions ≥35 letters and ≤67 letters at Visit 1 (Screening).\n  6. Have calculated baseline BCDVA at Visit 2 (Randomization; Baseline; Day 1) that simultaneously meets Randomization Criteria.\n  7. Have, in the opinion of the Investigator, age-related cataract (cortical, nuclear, posterior, mixed) in one or both eyes, as assessed using digital imaging after adequate mydriasis.\n\n     A. C \\\u003C 5.0 B. N \\\u003C 5.0 (both nuclear opalescence \\[NO\\] and nuclear color \\[NC\\]) C. P \\\u003C 1.0\n  8. Have, in the opinion of the Investigator, sufficiently clear ocular media and adequate pupillary dilation to permit quality fundus imaging.\n\nExclusion Criteria:\n\n* Ocular Exclusion Criteria:\n\nStudy Eye:\n\n1. Have a history of ocular trauma.\n2. Have a history of intraocular surgery, laser treatment, or corneal surgery. Note: Corneal refractive surgery more than 2 years prior to Visit 1 (Screening) is allowed.\n3. Have, in the opinion of the Investigator, a cataract other than age-related cataract (e.g., traumatic, concurrent, metabolic, drug and toxic, radiation).\n4. Have, in the opinion of the Investigator, any ocular disease or condition that is not stably controlled or is likely to affect central vision, including but not limited to:\n\n   Glaucoma Elevated IOP (e.g., ≥30 mmHg) Optic neuropathy Age-related macular degeneration Diabetic retinopathy Retinal artery or vein occlusion Macular hole Retinal detachment Epiretinal membrane involving the fovea High myopia (i.e., spherical equivalent of subjective refraction ≥ -7.0 D) High hyperopia (i.e., spherical equivalent of subjective refraction \\> +4.00 D)\n5. Have overall CFS \\>3.\n6. Have active eye infection or inflammation, including but not limited to conjunctivitis, keratitis, scleritis, or endophthalmitis.\n\n   Note: Mild inflammation (CFS \\\u003C3 on the NEI scale) from ocular surface disease, including dry eye disease, is allowed.\n\n   Non-study Eye:\n7. Have high-contrast BCDVA under photopic conditions ≤19 letters.\n\n   Either Eye:\n8. Have planned or be planning to undergo cataract surgery during the study. Note: A history of cataract surgery in the non-study eye is allowed for subjects who commit to not undergoing additional cataract surgery during the study.\n9. Have newly developed or not stably controlled uveitis within the 6 months prior to Visit 1 (Screening).\n10. Unwilling or unable to discontinue wearing contact lenses 14 days prior to Visit 2 (Randomization; Baseline; Day 1), and during the study conduct.\n11. Requires, is likely to require, or is unwilling to discontinue the use of prohibited medications or procedures within 14 days prior to Visit 1 (Screening), or during the study conduct.\n\n    A. Other ocular surgeries that may affect visual function, including but not limited to photodynamic therapy. B. Desferrioxamine, hydroxychloroquine, chloroquine, tamoxifen, phenothiazines, ethambutol, or other agents known to cause crystalline lens, retinal, or optic nerve toxicity.\n\n    C. Chlorpromazine or corticosteroids that may aggravate crystalline lens opacity.\n\n    Note: Topical non-ocular corticosteroids are allowed.\n\n    General Exclusion Criteria:\n12. Have a severe or not stably controlled systemic disease that may interfere with study participation or confound interpretability (e.g., acute phase of chronic obstructive pulmonary disease; congestive heart failure; severe hepatic or renal insufficiency; malignant tumors currently being treated with chemotherapy).\n13. Have diabetes mellitus with HbA1c ≥7.5%.\n14. Have hypertension that is not stably controlled at Visit 1 (Screening) A. Systolic blood pressure: \\>180 mmHg B. Diastolic blood pressure: \\>100 mmHg after standard of care\n15. Have participated or are planning to participate in a clinical study for an investigational drug\u002Fmedical device within 30 days prior to Visit 1 (Screening), or during the study conduct.\n16. Are pregnant, nursing, or planning a pregnancy during the study.\n17. Unwilling or unable to use an acceptable method of contraception throughout the study if a woman of childbearing potential (WOCBP).\n18. Unwilling or unable to use an acceptable method of contraception throughout the study if a male sexual partner of a WOCBP.\n19. Have a family member or household member enrolled in the study.\n20. Have any condition, in the opinion of the Investigator, that makes the subject unsuitable for study participation.",[76,77],"ADULT","OLDER_ADULT",[79,89,105,121,135,149,163,177,185,199,214,228,244,260,275,290,298,313,329,345,358],{"facility":80,"status":81,"city":82,"state":83,"zip":84,"country":85,"geoPoint":86},"Cornea and Cataract Consultants of Arizona","TERMINATED","Scottsdale","Arizona","85255","United States",{"lat":87,"lon":88},33.50921,-111.89903,{"facility":90,"status":7,"city":91,"state":83,"zip":92,"country":85,"contacts":93,"geoPoint":102},"Catalina Eye","Tucson","85712",[94,99],{"name":95,"role":96,"phone":97,"email":98},"Demetri Mendez","CONTACT","(520)-476-3315","demetri.mendez@nvisioncenters.com",{"name":100,"role":101},"Lynn Polonski","PRINCIPAL_INVESTIGATOR",{"lat":103,"lon":104},32.22174,-110.92648,{"facility":106,"status":7,"city":107,"state":108,"zip":109,"country":85,"contacts":110,"geoPoint":118},"Global Research Management","Glendale","California","91204",[111,116],{"name":112,"role":96,"phone":113,"phoneExt":114,"email":115},"Logi El-Harazi","818-246-2560","4111","logi@grmclinical.com",{"name":117,"role":101},"Sherif El-Harazi",{"lat":119,"lon":120},34.14251,-118.25508,{"facility":122,"status":7,"city":123,"state":108,"zip":124,"country":85,"contacts":125,"geoPoint":132},"Inland Eye Specialists","Hemet","92545",[126,130],{"name":127,"role":96,"phone":128,"email":129},"Jazmin Ponce","951-492-4205","jazmin.ponce@inlandeyespecialists.com",{"name":131,"role":101},"Robert Sorenson",{"lat":133,"lon":134},33.74761,-116.97307,{"facility":136,"status":7,"city":137,"state":108,"zip":138,"country":85,"contacts":139,"geoPoint":146},"United Medical Research Institute","Inglewood","90301",[140,144],{"name":141,"role":96,"phone":142,"email":143},"Carmen Marin-Caballero","310-645-4673","carmen@drjamespeace.com",{"name":145,"role":101},"James Peace",{"lat":147,"lon":148},33.96168,-118.35313,{"facility":150,"status":7,"city":151,"state":108,"zip":152,"country":85,"contacts":153,"geoPoint":160},"North Bay Eye Associates, Inc.","Petaluma","94954",[154,158],{"name":155,"role":96,"phone":156,"email":157},"Maria Suarez","707-769-2237","msuarez@northbayeye.com",{"name":159,"role":101},"Jason Bacharach",{"lat":161,"lon":162},38.23242,-122.63665,{"facility":164,"status":7,"city":165,"state":108,"zip":166,"country":85,"contacts":167,"geoPoint":174},"East West Eye Institute - Torrance","Torrance","90505",[168,172],{"name":169,"role":96,"phone":170,"email":171},"Natalie Ly","310-373-6708","nly@eastwesteye.com",{"name":173,"role":101},"Alex Liu",{"lat":175,"lon":176},33.83585,-118.34063,{"facility":178,"status":81,"city":179,"state":180,"zip":181,"country":85,"geoPoint":182},"ICON Eye Care","Grand Junction","Colorado","81501",{"lat":183,"lon":184},39.06387,-108.55065,{"facility":186,"status":7,"city":187,"state":180,"zip":188,"country":85,"contacts":189,"geoPoint":196},"Advanced Vision Research Institute","Longmont","80503",[190,194],{"name":191,"role":96,"phone":192,"email":193},"Elliot Minor","803-682-3399","eminor@eccnc.net",{"name":195,"role":101},"Anjali Sheth",{"lat":197,"lon":198},40.16721,-105.10193,{"facility":200,"status":7,"city":201,"state":202,"zip":203,"country":85,"contacts":204,"geoPoint":211},"Rand Eye Institute","Deerfield Beach","Florida","33064",[205,209],{"name":206,"role":96,"phone":207,"email":208},"Maciej Feret","954-782-1700","mferet@randeye.com",{"name":210,"role":101},"David Rand",{"lat":212,"lon":213},26.31841,-80.09977,{"facility":215,"status":7,"city":216,"state":202,"zip":217,"country":85,"contacts":218,"geoPoint":225},"Levenson Eye Associates","Jacksonville","32204",[219,223],{"name":220,"role":96,"phone":221,"email":222},"Kayla Cobb","904-366-3799","kcobb@aspireclinicaltrials.com",{"name":224,"role":101},"Jeffrey Levenson",{"lat":226,"lon":227},30.33218,-81.65565,{"facility":229,"status":7,"city":230,"state":231,"zip":232,"country":85,"contacts":233,"geoPoint":241},"Clayton Eye Clinical Research, LLC","Morrow","Georgia","30260",[234,239],{"name":235,"role":96,"phone":236,"phoneExt":237,"email":238},"Jahanzeb \"Jay\" Khan","770-968-8888","5","jahanzebkhan@claytoneye.net",{"name":240,"role":101},"Lauren DuBiner",{"lat":242,"lon":243},33.58317,-84.33937,{"facility":245,"status":7,"city":246,"state":247,"zip":248,"country":85,"contacts":249,"geoPoint":257},"Springfield Clinic","Springfield","Illinois","62703",[250,255],{"name":251,"role":96,"phone":252,"phoneExt":253,"email":254},"Evelina Neverdauskaite","217-280-9160","75534","eneverdauskaite@springfieldclinic.com",{"name":256,"role":101},"Ramanath Bhandari",{"lat":258,"lon":259},39.80172,-89.64371,{"facility":261,"status":7,"city":262,"state":263,"zip":264,"country":85,"contacts":265,"geoPoint":272},"Oculus Research - Cary","Cary","North Carolina","27518",[266,270],{"name":267,"role":96,"phone":268,"email":269},"Angel Garcia","919-346-6945","angel.garcia@oculusresearch.com",{"name":271,"role":101},"Amit Kumar",{"lat":273,"lon":274},35.79154,-78.78112,{"facility":276,"status":7,"city":277,"state":278,"zip":279,"country":85,"contacts":280,"geoPoint":287},"Bergstrom Eye Research","Fargo","North Dakota","58103",[281,285],{"name":282,"role":96,"phone":283,"email":284},"Angela Callaghan","701-478-0061","angie@bergstromeye.com",{"name":286,"role":101},"Lance Bergstrom",{"lat":288,"lon":289},46.87719,-96.7898,{"facility":291,"status":81,"city":292,"state":293,"zip":294,"country":85,"geoPoint":295},"Cincinnati Eye Institute - Blue Ash","Blue Ash","Ohio","45242",{"lat":296,"lon":297},39.232,-84.37827,{"facility":299,"status":7,"city":300,"state":301,"zip":302,"country":85,"contacts":303,"geoPoint":310},"Verum Research","Eugene","Oregon","97401",[304,308],{"name":305,"role":96,"phone":306,"email":307},"Ryan Lebien","541-762-2763","rlebien@verumresearch.com",{"name":309,"role":101},"Albert Edwards",{"lat":311,"lon":312},44.05207,-123.08675,{"facility":314,"status":7,"city":315,"state":316,"zip":317,"country":85,"contacts":318,"geoPoint":326},"Erie Retina Research","Erie","Pennsylvania","16505",[319,324],{"name":320,"role":96,"phone":321,"phoneExt":322,"email":323},"Aria Dixon","814-200-9152","101","adixon@casexerie.com",{"name":325,"role":101},"David Almeida",{"lat":327,"lon":328},42.12922,-80.08506,{"facility":330,"status":7,"city":331,"state":332,"zip":333,"country":85,"contacts":334,"geoPoint":342},"Valley Retina Institute P.A.","Laredo","Texas","78041",[335,340],{"name":336,"role":96,"phone":337,"phoneExt":338,"email":339},"Annette Liendo","956-724-7179","1350","annette.liendo@eyeptcare.com",{"name":341,"role":101},"Victor Gonzalez",{"lat":343,"lon":344},27.50641,-99.50754,{"facility":330,"status":7,"city":346,"state":332,"zip":347,"country":85,"contacts":348,"geoPoint":355},"McAllen","78503",[349,354],{"name":350,"role":96,"phone":351,"phoneExt":352,"email":353},"Melida Flores","956-631-8875","1167","melida.flores@eyeptcare.com",{"name":341,"role":101},{"lat":356,"lon":357},26.20341,-98.23001,{"facility":359,"status":7,"city":360,"state":332,"zip":361,"country":85,"contacts":362,"geoPoint":369},"R and R Eye Research, LLC","San Antonio","78229",[363,367],{"name":364,"role":96,"phone":365,"email":366},"Catherine (Maggie) Hazen","210-484-2584","maggie@eye-assoc.com",{"name":368,"role":101},"Gregory Brunin",{"lat":370,"lon":371},29.42412,-98.49363,[],[],[],[],{"nct_id":4,"conditions":377,"biomarkers":379},[378],"Senile Cataract",[],{"nct_id":4,"found":381,"summary":382,"prompt_version":392},true,{"design":383,"status":384,"heading":385,"summary":386,"follow_up":387,"word_count":388,"commitments":389,"compensation":390,"drugs_mentioned":391},"This is a randomized, double-masked (neither you nor your doctor will know if you're getting the active drug or placebo), placebo-controlled pilot study involving about 40 participants.","completed","ZOC2017217 for Age-Related Cataract","This study is testing an investigational eye drop called ZOC2017217 for people with age-related cataracts. It's a pilot study, meaning it's an early look at how well ZOC2017217 works and if it's safe. About 40 people aged 50 and older will participate. You would use either ZOC2017217 or a placebo (an inactive substance) in both eyes twice a day for 24 weeks. Researchers will measure your vision (Best Corrected Distance Visual Acuity or BCDVA), how well you see in low light (contrast sensitivity), and your overall vision-related quality of life (Visual Function Questionnaire or VFQ-25) to see if ZOC2017217 helps. The study's current status is unclear.","After 24 weeks of treatment, participants with new or ongoing eye-related side effects will have a safety follow-up evaluation 2 weeks later.",106,"You would administer eye drops twice a day for 24 weeks. Your vision will be checked at the start, and at weeks 4, 12, and 24.","Not stated in the trial record.",[],"v2"]