[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Lunan Better Pharmaceutical Co., LTD.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":73},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,42],{"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":27,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100583704","phase-3-phase-iii-clinical-study-of-lifitegrast-ophthalmic-solution-for-the-treatment-of-dry-eye-disease-100583704",false,"NCT06879782","Phase III Clinical Study of Lifitegrast Ophthalmic Solution for the Treatment of Dry Eye Disease","A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Clinical Study on the Efficacy and Safety of Lifitegrast Ophthalmic Solution for the Treatment of Dry Eye Disease.","Inclusion Criteria:\n\n1. Voluntary participation and signing of the informed consent form, willingness to comply with the treatment regimen prescribed by the trial protocol, and willingness to attend follow-up visits on time.\n2. Age ≥18 years, regardless of gender.\n3. Best corrected visual acuity ≥4.3 in both eyes (OU) at the screening visit (V1 visit).\n4. History of dry eye disease in both eyes prior to the screening visit (V1 visit) (with at least one subjective symptom such as eye dryness, foreign body sensation, burning sensation, fatigue, discomfort, eye redness, or fluctuating vision).\n5. Use of artificial tears within 30 days prior to the screening visit (V1 visit) to alleviate dry eye disease (DED) symptoms, with discontinuation of artificial tears at least 72 hours prior to the screening period, and willingness to refrain from using artificial tears during the trial.\n6. Total Ocular Surface Disease Index (OSDI) score ≥13 at the screening visit (V1 visit).\n7. Corneal fluorescein staining score ≥2 in at least one region of at least one eye and the same eye at both the screening visit (V1 visit) and baseline visit (V2 visit).\n8. Conjunctival hyperemia score ≥1 in at least one eye at both V1 and V2 visits.\n9. Eye Dryness Score (EDS) ≥40 (VAS score, OU) at both V1 and V2 visits.\n10. At least one eye and the same eye meeting the following criteria at both V1 and V2 visits:\n\nInferior Corneal Fluorescein Staining Score (ICSS) ≥0.5; Schirmer's test (without anesthesia) ≥1 mm and ≤10 mm.- If both eyes meet the above criteria, the eye with the higher Inferior Corneal Fluorescein Staining Score (ICSS) at the V2 visit will be selected as the study eye. If both eyes have the same ICSS at the V2 visit, the eye with the lower Schirmer's Tear Test (STT) value at the V2 visit will be designated as the study eye. If both eyes have the same ICSS and STT values at the V2 visit, the right eye will be selected as the study eye.\n\nExclusion Criteria:\n\n1. Currently suffering from ocular herpes or any other ocular infection or inflammation, or having a history of ocular herpes or any other ocular infection within 30 days prior to screening.\n2. Presence of eyelid margin structural abnormalities (ectropion, entropion, eyelid laxity, etc.), severe conjunctivochalasis, Salzmann's nodular corneal degeneration, conjunctival goblet cell damage (e.g., vitamin A deficiency), progressive pterygium, wet age-related macular degeneration (wAMD), glaucoma, diabetic retinopathy, retinal vein occlusion, or other ocular diseases that, in the investigator's opinion, may increase the subject's risk or affect the trial results.\n3. Ocular secondary scarring (e.g., radiation scars, chemical burns, Stevens-Johnson syndrome, cicatricial pemphigoid, etc.) that, in the investigator's opinion, may affect subject compliance or outcome assessment.\n4. Subjects with secondary Sjögren's syndrome or other autoimmune diseases (e.g., rheumatoid arthritis, systemic lupus erythematosus, etc.), unless the subject meets the following conditions: a. Not using corticosteroids, immunomodulatory, or immunosuppressive drugs for the condition; b. The investigator considers that the medical condition will not affect the trial results.\n5. History of organ or bone marrow transplantation.\n6. Wearing contact lenses within 30 days prior to screening.\n7. Undergoing physical treatments for dry eye (including eyelid scrubs, meibomian gland massage, warm compresses, steam treatments, etc.) within 30 days prior to screening.\n8. Use of aspirin or aspirin-containing medications, non-steroidal drugs (including ocular or systemic use), or medications that may cause dry eye (e.g., anticholinergic drugs, serotonin reuptake inhibitors, etc.) within 30 days prior to the baseline visit (V2 visit), unless the subject has been on a stable dose for at least 30 days prior to the baseline visit and no change in dosage is expected during the trial.\n9. Use of the following medications within the specified timeframes prior to the baseline visit (V2 visit): a. Ocular or systemic antihistamines, any ocular medications: within 14 days prior to V2 visit; b. Ocular cyclosporine, tacrolimus: within 6 weeks prior to V2 visit; c. Ocular or systemic corticosteroids, mast cell stabilizers: within 14 days prior to V2 visit.\n10. History of punctal plug insertion or punctal cauterization within 12 weeks prior to screening.\n11. Use of anti-glaucoma medications within 3 months prior to screening, history of non-laser glaucoma surgery, or laser glaucoma surgery within 6 months prior to screening.\n12. History of YAG laser posterior capsulotomy within 6 months prior to screening, or corneal refractive surgery (e.g., LASIK) within 12 months prior to screening.\n13. Known allergy to fluorescein, multiple allergies, or severe allergic diseases.\n14. Presence of other uncontrolled clinical conditions (e.g., severe chronic infections, severe cardiopulmonary diseases, uncontrolled hypertension \\[defined as systolic blood pressure ≥150 mmHg or diastolic blood pressure ≥100 mmHg despite antihypertensive treatment\\], uncontrolled diabetes, malignancies, etc.).\n15. Positive pregnancy test or lactating subjects (females only), or subjects of childbearing potential or male subjects with partners of childbearing potential who are unwilling to use contraception during the study and for 1 month after the last dose of study medication.\n16. Participation in any other clinical trial involving investigational drugs\u002Fdevices within 30 days prior to screening.\n17. Poor compliance during the placebo washout period (compliance \\\u003C80% or \\>120%).\n18. Other conditions deemed unsuitable for enrollment by the investigator (e.g., depression, ocular mite infection, etc.). -","ALL","18 Years",{"count":19,"type":20},820,"ESTIMATED","INTERVENTIONAL",[23],"PHASE3","This study is a multicenter, randomized, double-blind, placebo-controlled Phase III clinical trial designed to evaluate the efficacy and safety of Lifitegrast Ophthalmic Solution.",[26],"Dry Eye Disease (DED)",[28],"Lifitegrast，Dry eye disease (DED)","RECRUITING","2025-03-14",{"date":32,"type":33},"2025-03-17","ACTUAL",{"date":35,"type":33},"2024-03-28",{"date":37,"type":20},"2026-09-28",{"name":39,"class":40},"Lunan Better Pharmaceutical Co., LTD.","INDUSTRY",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":50,"enrollmentInfo":51,"targetDuration":4,"studyType":21,"phases":53,"briefSummary":55,"conditions":56,"keywords":58,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":4},"100574954","phase-2-efficacy-and-safety-of-isosorbide-oral-solution-in-patients-with-menieres-disease-100574954","NCT06765993","Efficacy and Safety of Isosorbide Oral Solution in Patients With Meniere's Disease","A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II\u002FIII Clinical Study of Isosorbide Oral Solution in the Treatment of Meniere's Disease","MD","Inclusion Criteria:\n\n1. Male or female aged ≥18 and ≤65 years old.\n2. Patients with unilateral Meniere's disease who meet the diagnostic criteria for Meniere's disease in the Guidelines for the Diagnosis and Treatment of Meniere's Disease (2017).\n3. At least 3 episodes of vertigo caused by Meniere's disease within 6 months before enrollment.\n4. Those who understand and voluntarily sign the informed consent.\n\nExclusion Criteria:\n\n1. Patients who have had previous ear surgery for Meniere's disease.\n2. People who suffer from vertigo caused by organic lesions of the external, middle or inner ear.\n3. Patients with diseases that the investigators believe may limit the subjects' participation in this trial:\n\n   * patients with acute intracranial hematoma;\n   * patients with hypokalemia (serum potassium \\\u003C lower limit of normal) or severe dehydration (needing infusion, or hospitalization, or life-threatening, requiring emergency treatment);\n   * patients with acute pulmonary edema;\n   * patients with hypotension (systolic blood pressure \\\u003C90 mmHg and\u002For diastolic blood pressure \\\u003C60 mmHg during the screening period);\n   * patients with severe cardiovascular and cerebrovascular diseases: such as New York Heart Association grade III or IV heart failure, myocardial infarction or unstable angina pectoris within the last 6 months, severe heart failure, progressive multifocal leukoencephalopathy, hypertension that is difficult to control with drugs (systolic blood pressure ≥180 mmHg and\u002For diastolic blood pressure ≥100 mmHg), etc.;\n   * patients with major diseases of other important organs that affect their participation in this study.\n4. Patients who need to use diuretics other than trial drugs for a long time after enrollment.\n5. Patients with any of the following conditions are known or found in laboratory tests:\n\n   * serum creatinine (Cr) level is not within the normal range;\n   * human immunodeficiency virus (HIV) test is positive or has acquired immunodeficiency syndrome (AIDS);\n   * active syphilis infection (positive Treponema pallidum antibody and positive non-specific syphilis antibody);\n   * active hepatitis, hepatitis B: HBsAg and\u002For HBcAb are positive and HBV-DNA \\> 500 IU\u002FmL or the lower limit of detection of the research center \\[only when the lower limit of detection of the research center is higher than 500 IU\u002FmL\\]; hepatitis C: HCV antibody is positive and HCV-RNA is positive or greater than the upper limit of normal value.\n6. Patients with known or suspected history of allergy to the investigational drug (isosorbide) and its excipients (sorbitol, lactic acid, saccharin sodium, propylparaben, butylparaben, orange flavor).\n7. Those with a history of drug abuse or alcoholism within 6 months before enrollment.\n8. Patients who have taken any prohibited drugs specified in this protocol for more than 1 week within 4 weeks before the first administration, including but not limited to vestibular suppressants (including antihistamines - promethazine, diphenhydramine, chlorpheniramine, etc., benzodiazepines - diazepam, lorazepam, clonazepam, etc., anticholinergics - scopolamine, atropine, glycopyrrolate, etc., and antidopamines - prochlorperazine, droperidol, etc.), betahistine, diuretics (including thiazide diuretics - hydrochlorothiazide, chlorthalidone, indapamide, indapamide sustained-release tablets, etc., loop diuretics - furosemide, torsemide, etc., potassium-sparing diuretics - amiloride, triamterene, etc.), glucocorticoids (including prednisone, methylprednisolone, betamethasone, beclomethasone propionate, prednisolone, hydrocortisone, dexamethasone, etc.).\n9. Those who received intratympanic injection of gentamicin within the last year.\n10. Patients who have received any other clinical trial drugs\u002Fdevices within 30 days before the first dose.\n11. Pregnant or lactating women, female patients or male patients' partners who plan to become pregnant during the study period and within 6 months after the last dose, and those who are unwilling to use a medically recognized effective contraceptive method (such as intrauterine contraceptive device or condom) during the trial.\n12. Those who are judged by the researchers to be unsuitable for inclusion.","65 Years",{"count":52,"type":20},234,[54,23],"PHASE2","The purpose of this study is to evaluate the efficacy and safety of isosorbide oral solution compared with placebo in people with unilateral Meniere's disease. A total of approximately 234 subjects will be enrolled in this study: 72 subjects in phase Ⅱ and approximately 162 subjects in phase Ⅲ. Patients were randomly assigned to either the experimental group or the control group. The randomization ratios for phase Ⅱ and phase Ⅲ were 1:1 and 2:1, respectively.",[57],"Meniere´s Disease",[59,60,61,62,63],"Meniere´s disease","Attack","Hearing loss","Tinnitus","Isosorbide","NOT_YET_RECRUITING","2025-01-03",{"date":67,"type":33},"2025-01-09",{"date":69,"type":20},"2024-12-30",{"date":71,"type":20},"2027-12-30",{"name":39,"class":40},""]