[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":93},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,40,62],{"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":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100574982","phase-3-a-study-of-the-efficacy-and-safety-of-cyclosporin-ophthalmic-gel-in-subjects-with-moderate-to-severe-dry-eye-disease-100574982",false,"NCT06766357","A Study of the Efficacy and Safety of Cyclosporin Ophthalmic Gel in Subjects With Moderate to Severe Dry Eye Disease","A Phase 3, Multicenter, Randomized, Double-blind, Vehicle-controlled Efficacy and Safety Study of Cyclosporin Ophthalmic Gel in Subjects With Moderate to Severe Dry Eye Disease","Inclusion Criteria:\n\n1. aged ≥ 18 years old, males or females.\n2. Subjects complained of ocular dryness in both eyes for at least 6 months at Visit 1.\n3. Eye dryness score(EDS)(evaluated on a 0-100 VAS score) ≥40 at Visit 1 and Visit 2.\n4. Ocular Surface Disease Index (OSDI) score ≥13 at Visit 1 and Visit 2.\n5. Total corneal fluorescein staining score (tCFS) ≥2 in either eye and ≥1 in at least one region at Visit 1 and Visit 2.\n6. Schirmer I test (without anesthesia) ≤ 5 mm\u002F5 min in either eye at Visit 1 and Visit 2.\n7. Subjects with moderate and severe dry eye in both eyes at Visit 1 and Visit 2:\n\n   1. Moderate: ≥1 quadrant and no more than 2 quadrants of corneal damage and\u002For ≥5 and \\\u003C30 corneal fluorescein staining spots on slit lamp microscopy;\n   2. Severe: ≥2 quadrants of corneal damage and\u002For ≥30 corneal fluorescence staining spots on slit lamp microscopy.\n\nExclusion Criteria:\n\n1. Subjects with severe dry eye requiring surgical treatment.\n2. Systemic use of retinoids within the 12 months prior to Visit 1.\n3. Subjects who have had intraocular surgery within 12 months prior to Visit 1 or who require intraocular surgery during the study; or subjects who have had eyelid surgery within 6 months prior to Visit 1.\n4. Subjects treated with permanent lacrimal duct embolization; or subjects treated with temporary lacrimal duct embolization within 6 months prior to Visit 1.\n5. Subjects with dry eye correlated with operation；\n6. Subjects who had worn corneal contact lens within 3 months prior to Visit 1.\n7. Those who have used cyclosporine preparations ocularly or systemically within 1 month prior to visit 1.\n8. Those who have used lifitegrast eye drops or tacrolimus eye drops ocularly within 1 month prior to visit 1.\n9. Subjects with dry eye secondary to scarring (e.g., radiation exposure, ocular chemical burns, Stevens-Johnson syndrome, keloid pemphigoid, conjunctival scarring) or severe conjunctival cup cells destruction (e.g., vitamin A deficiency).\n10. Those with significant eyelid margin inflammation or meibomian gland dysfunction that, in the opinion of the investigator, may affect the outcome of the trial.","ALL","18 Years",{"count":19,"type":20},360,"ESTIMATED","INTERVENTIONAL",[23],"PHASE3","This study is a multicenter, randomized, double-blind, placebo-controlled, superiority design Phase III clinical trial. The primary objective is to evaluate the efficacy and safety of cyclosporine ophthalmic gel versus placebo in the treatment of moderate to severe dry eye for 84 days.",[26],"Moderate to Severe Dry Eye","RECRUITING","2025-07-25",{"date":30,"type":31},"2025-07-28","ACTUAL",{"date":33,"type":31},"2025-04-03",{"date":35,"type":20},"2026-06",{"name":37,"class":38},"Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.","INDUSTRY",1,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":47,"targetDuration":4,"studyType":21,"phases":49,"briefSummary":50,"conditions":51,"keywords":4,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":54,"lastUpdatePostDateStruct":55,"startDateStruct":57,"completionDateStruct":59,"leadSponsor":61,"locationsCount":4},"100588545","phase-3-a-study-to-evaluate-the-efficacy-and-safety-of-treatment-with-csa-pg-ophthalmic-gel-in-dry-eye-patients-100588545","NCT06942793","A Study to Evaluate the Efficacy and Safety of Treatment With CsA-PG Ophthalmic Gel in Dry Eye Patients","A Phase 3, Multicenter, Randomized, Double-Masked, Active-Controlled Study to Evaluate the Efficacy and Safety of Treatment With CsA-PG Ophthalmic Gel in Dry Eye Patients","Inclusion Criteria:\n\n1. Be at least 18 years of age, male or female;\n2. Provide written informed consent;\n3. Have a reported history of dry eye for at least 6 months before Visit 1;\n4. Have a clinical diagnosis of bilateral dry eye disease, including all of the following scored in at least one eye at both Visits 1 and 2;\n\n   1. Corneal fluorescein staining score in either inferior, superior, or central zone ≥ 2\n   2. Schirmer Tear Test score (STT, anesthetized) of ≤ 10 mm and ≥ 1 mm\n   3. Have an Eye Dryness Score (EDS; Visual Analogue scale, VAS) ≤80 and ≥40\n\nExclusion Criteria:\n\n1. Clinical diagnosis or history of any clinically significant ocular diseases\u002Fdisorders (e.g., age-related maculopathy that requires treatment and\u002For in the opinion of the Investigator may interfere with study parameters in Visit 1 and\u002For Visit 2;\n2. Any active ocular or systemic infection (e.g., bacterial, viral, or fungal) at Visit 1 and\u002For Visit 2;\n3. Any active ocular inflammation (e.g., iritis, uveitis, allergic conjunctivitis) at Visit 1 and\u002For Visit 2;\n4. Any conjunctival scarring history (Such as with irradiation, alkali burns, Steven Johnson syndrome, Sjogren's syndrome, cicatricial pemphigoid) or destruction of conjunctival goblet cells (e.g., neurotrophic keratitis, vitamin A deficiency) before Visit 1;\n5. Have worn contact lenses within 14 days of Visit 1 or anticipate using contact lenses during the study;\n6. Have any refractive surgery and\u002For any other ocular surgical procedure within 3 months before Visit 1; or have any ocular surgical procedure scheduled to be conducted during the study period;\n7. Have eyelid surgery within 6 months before Visit 1 or planned eyelid surgery during the study period;\n8. Have Nd:YAG (neodymium-doped yttrium aluminum garnet) laser capsulotomy within 6 months before Visit 1;\n9. Have used temporary (i.e., collagen) punctual plugs within 3 months before Visit 1 or anticipate their use during the study period;\n10. Have permanent punctual plugs inserted or have surgical punctual occlusion before Visit 1 or anticipate any such event during the study period;\n11. Use any of the following treatments in the period indicated before Visit 1 or anticipate their use at any time during the study.\n\n    Topical medications（30 days prior to Visit 1）:\n    * Restasis®, Cequa™, Tyrvaya, Eysuvis, Xiidra\n    * Topical ophthalmic non-steroidal anti-inflammatories\n    * Topical ophthalmic corticosteroids\n    * Topical ophthalmic autologous serum Exceptions: demulcent ophthalmic drops (e.g., OCCT artificial tears) may be used until Screen Visit 1, but these must be discontinued after screening.\n\n    Systemic medication (30 days before Visit 1):\n\n    Any systemic medication known to cause ocular drying (e.g., antidepressants, beta blockers) except if it was taken on a stable dosing regimen for at least 30 days before Visit 1 and is expected to be taken on the same regimen throughout the study period. The known systemic medications that can cause ocular drying include:\n    * antihistamines, antidepressants, bronchodilators, antiarrhythmics\n    * anti-Parkinson's disease drugs, antipsychotics, antitussives, anticongestants\n    * adrenoceptor blockers, thiazide diuretics, anti-leprosy drugs, antimalarials, antineoplastics anxiolytics\u002Fsleeping agents, herbs and vitamins, calcium modulators\n    * Corticosteroids (e.g., systemic steroids including intravenous, intramuscular, intraarticular, and oral steroids; facial topical steroids; dermatological steroids with high potency or large treatment areas)\n    * Cyclosporine and any other immunosuppressor\n    * Other medications that can impact dry eye disease favorably or not include various analgesics, including opiates, cannabinoids, omega-3 dietary supplements, and other agents. Such meds should be continued on study only if that represents a continuation of an unavoidable and unchanged regimen of treatment for a disease that is not otherwise excluded\n\n    Non-medicine treatment (30 days before Visit 1):\n    * LipiFlow® or other similar meibomian gland dysfunction (MGD) therapy;\n    * Eye mask with heat or steam and any other warming method of the eyelid (e.g., warm towel application);\n    * Intense pulsed light treatment;\n    * Bandage contact lenses or scleral contact lenses;\n    * Route eyelid cleaning;\n    * Any other treatment that will relieve dry eye symptoms and signs.\n12. Have a severe\u002Fserious systemic disease, chronic illness, or uncontrolled medical condition including, but not limited to, severe cardiopulmonary disease, poorly controlled hypertension, poorly controlled diabetes, and\u002For clinically significant (CS) hematologic, renal, or liver disease that in the opinion of the Investigator could interfere with study assessments or limit compliance;\n13. Be a woman who is pregnant, nursing, or planning a pregnancy;\n14. Be unwilling to submit a urine pregnancy test at Visit 1 and Visit 5 (or early termination visit) if of childbearing potential. The non-childbearing potential is defined as a woman who is permanently sterilized (e.g., has had a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or is post-menopausal (i.e., without menses for 12 consecutive months);\n15. Be a woman of childbearing potential who is not using an acceptable means of birth control during the study period and 30 days after the end of the study. Acceptable methods of contraception include hormonal (e.g., oral, implantable, injectable, or transdermal contraceptives), mechanical (e.g., spermicide in conjunction with a barrier such as a diaphragm or a condom), intrauterine device (IUD), or surgical sterilization of partner. For non-sexually active females, abstinence might be regarded as an adequate method of birth control; however, if the subject becomes sexually active during the study, she must agree to use acceptable birth control as defined above for the remainder of the study;\n16. Have a known hypersensitivity or contraindication to the investigational products (IPs) or their components;\n17. Have a condition or be in a situation that the Investigator felt may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study (e.g., any planned procedure or surgery during the study period);\n18. Be currently enrolled in an investigational drug or device study or have used an investigational drug or device within 30 days before Visit 1;\n19. In the opinion of the Investigator, be unable or unwilling to comply with the study protocol, including participation in all study assessments, visits, and dosing, or be unable to instill eye drops successfully.",{"count":48,"type":20},396,[23],"This is a phase III, multicenter, randomized, double-masked, Active-controlled design. The aims to confirm previous findings of the efficacy and safety of CsA-PG Ophthalmic Gel by comparing it to CsA Ophthalmic Gel for treating dry eye symptoms.",[52],"Dry Eye Disease","NOT_YET_RECRUITING","2025-04-24",{"date":56,"type":31},"2025-04-29",{"date":58,"type":20},"2025-05-20",{"date":60,"type":20},"2025-11-15",{"name":37,"class":38},{"id":63,"slug":64,"hasResults":11,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":4,"eligibilityCriteria":68,"healthyVolunteers":11,"sex":16,"minAge":69,"maxAge":70,"enrollmentInfo":71,"targetDuration":4,"studyType":21,"phases":73,"briefSummary":75,"conditions":76,"keywords":78,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":39},"100588972","phase-2-efficacy-and-safety-of-brimochol-pf-and-carbachol-pf-in-chinese-presbyopia-patients-100588972","NCT06948357","Efficacy and Safety of BRIMOCHOL PF and CARBACHOL PF in Chinese Presbyopia Patients","A Multicenter, Randomized, Double-Blind, Crossover, Placebo-Controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of BRIMOCHOL PF, CARBACHOL PF in Chinese Patients With Presbyopia","Inclusion Criteria:\n\n1. At Visit 1 (Screening Period), the age ranges from 45 to 75 years old, regardless of gender\n2. At Visit 1 (Screening Period), the corrected distance visual acuity of either eye is ≥ 0.8 (National Standard Logarithmic Visual Acuity Scale,decimal visual acuity) in the clinical routine manifest refraction (distance vision).\n3. At Visit 1 (Screening Period), the manifest refraction (distance vision under mesopic conditions) results are as follows: For any eye,-4.00D ≤ equivalent spherical lens power ≤ +2.00D, and the negative cylinder lens power is ≥-2.00D;\n4. At least one eye meeting the following at both Visit 1 and Visit 2:\n\n   1. Under mesopic conditions, monocular corrected near visual acuity (MCNVA) ≤65 ETDRS letters (equivalent to decimal visual acuity 0.4) ;\n   2. Under mesopic conditions, monocular corrected near visual acuity with a multiple-pinhole occluder (MCNVA\\_P) improves by ≥15 ETDRS letters compared to monocular corrected near visual acuity without the occluder (MCNVA).\n5. During Visit 1 (Screening Period) and Visit 2, both eyes must meet the following criteria:under mesopic conditions, binocular corrected near visual acuity (BCNVA) is ≤65 ETDRS letters (equivalent to decimal visual acuity 0.4);\n6. Any eye is phakic or implanted with a monofocal intraocular lens (IOL);\n7. Normal iris and pupillary morphology in any eye, with normal light reflex and an interocular pupillary diameter difference ≤1 mm during screening;\n\nExclusion Criteria:\n\n1. Use of corneal or scleral contact lenses within 28 days prior to screening or planned for the duration of the study;\n2. Narrow anterior chamber angle (Van Herick grade ≤2 via slit lamp examination) or previous iridotomy or resection in either eye；\n3. Ocular history in any eye: hyphema, ciliary body detachment, iridodonesis, or ocular trauma；\n4. Any eye with a corneal abnormality that, in the judgment of the investigator, affects visual acuity or intraocular pressure measurements, including moderate to severe dry eye (e.g., significant signs of ocular surface damage (≥5 corneal fluorescein staining spots) on slit lamp microscopy);\n5. Any phakic eye has a history of lens tremor, subluxation, or suspected zonular laxity; or any pseudophakic eye has undergone posterior capsulotomy or uses multifocal or extended depth of focus intraocular lenses.\n6. Any eye with an axial length of ≥26mm;\n7. Either eye has undergone intraocular or corneal surgery (only non-complicated cataract surgery with a monofocal lens placed in the capsular bag more than 6 months after the date of surgery is permitted; complicated cataract surgery is defined as surgery that has resulted in a rupture of the capsule or placement of an IOL outside the capsule (ciliary sulcus, scleral or iris fixation, anterior chamber, etc.));\n8. Either eye has a history of congenital or traumatic cataract, congenital aphakia, or opacities in the refractive media that affect visual acuity in the visual axis area.\n9. History of uveitis, low intraocular pressure (IOP \\\u003C 9 mmHg), glaucoma or hypertension (IOP \\> 21 mmHg) or pseudoexfoliation syndrome in either eye;\n10. Active ocular or periocular infection or inflammation in either eye, or a history of recurrent infection or chronic infection (e.g., herpes virus infection) in either eye;\n11. Either eye has a history of retinal diseases (such as retinal detachment, age-related macular degeneration, diabetic retinopathy, peripheral retinal diseases that increase the risk of the subject as judged by the investigator) or optic nerve abnormalities.\n12. During the screening period, any eye has any ocular disease other than presbyopia that requires treatment with ocular preparations, intravitreal injection or ocular surgery during the study period (except artificial tears, which can be used on the day of ocular examination during the screening period and on non-treatment visits).","45 Years","75 Years",{"count":72,"type":20},119,[74],"PHASE2","A multicenter, randomized, double-Blind, crossover, placebo-controlled Phase II clinical Study to evaluate the efficacy and safety of BRIMOCHOL PF and CARBACHOL PF in the treatment of Chinese patients with presbyopia.",[77],"Presbyopia",[79,80,81,82,83,84,85],"presbyopia","eye drops","ophthalmic solution","Chinese","Brimochol","Carbachol","Brimonidine","2025-04-23",{"date":56,"type":31},{"date":89,"type":31},"2025-03-24",{"date":91,"type":20},"2025-12-30",{"name":37,"class":38},""]