[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"iVeena Delivery Systems, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":70},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,45],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100621435","phase-1-a-safety-study-of-ivmed-85-ophthalmic-solution-in-healthy-adults-100621435",false,"NCT07370584","A Safety Study of IVMED-85 Ophthalmic Solution in Healthy Adults","A Randomized, Vehicle-Controlled, Double-Masked Study of the Safety of IVMED-85 Ophthalmic Solution in Healthy Adults","Inclusion Criteria:\n\n* Subjects who meet all the following inclusion criteria at Visit 1 will be eligible to enroll in the study. Ocular criteria apply to both eyes.\n\n  1. Age 18-49. -\n  2. Ability to voluntarily provide written informed consent. -\n  3. Being clinically healthy, as determined by the investigator. -\n  4. Willing and able to comply with clinic visits and study-related procedures. -\n  5. Willing and able to discontinue use of topical ocular medications, unless approved by investigator. Note: Artificial tears are allowed but must not be used within 30 minutes before or after administration of the study investigational product (IP). -\n  6. BCVA better than or equal to 0.2 logarithm of the minimum angle of resolution (logMAR) (20\u002F30 Snellen equivalent). -\n  7. Corneal thickness 450 to 670 μm. -\n  8. Intraocular pressure (IOP) ≤22 mmHg. -\n  9. Willingness to not wear mascara for 6 weeks of the study. -\n  10. Willingness to not swim in an indoor pool for 6 weeks of the study. -\n\nExclusion Criteria:\n\nSubjects who meet any of the following criteria at Visit 1 will not be eligible to enroll in the study. Ocular criteria apply to either eye.\n\n1. Participation in a clinical trial with the use of any investigational drug or treatment within 30 days prior to Visit 1 and duration of the study. -\n2. Known copper allergy, sensitivity, or processing disorder (e.g., Wilson's disease). -\n3. Presence of significant central corneal scarring or hydrops. -\n4. History or presence of punctal stenosis or bloody discharge. -\n5. History of or presence of nasolacrimal duct occlusion, nasolacrimal system trauma, nasolacrimal or eyelid cancer, ectropion or entropion, dacryocystitis, dacryoadenitis, chronic conjunctivitis, recurrent subconjunctival hemorrhage, trichiasis, distichiasis, or uncontrolled dry eye. -\n6. Previous cornea, glaucoma, eyelid, strabismus (exotropia or esotropia), or intraocular surgeries. -\n7. Current or previous ocular disorder, including but not limited to: strabismus (exotropia or esotropia), amblyopia, glaucoma, macular degeneration, cataract, retinal detachment or nystagmus, or abnormality of the central cornea, lens, iris, ciliary body, or central retina. -\n8. Presence of any medical condition predisposing the subject to craniofacial anomalies, degenerative myopia, or abnormal ocular refractive anatomy (e.g., osteogenesis imperfecta or Stickler, Down, Ehlers-Danlos, Donnai-Barrow, Treacher-Collins, or Apert\u002FCrouzon\u002F Pfeiffer syndrome). -\n9. Active or recent (within 2 weeks prior to screening) bacterial, viral, or allergic conjunctivitis. -\n10. Active allergies causing uncontrolled ocular and nasal symptoms. -\n11. Active sinusitis. -\n12. Current or previous hypothyroidism or hyperthyroidism. -\n13. Ongoing or recent (within 3 months prior to screening) chronic use of eyedrops containing preservatives such as benzalkonium chloride (BAK), Purite, or Polyquad. -\n14. History of uncontrolled gastroenteric reflux disease or deviated nasal septum. -\n15. If a female of childbearing potential (FOCBP):\n\n    1. Are pregnant or lactating.\n    2. Are unwilling to use an effective form of contraception (e.g., hormonal, oral, transdermal, implant, injection, or abstinence) for the duration of the study. -\n16. A male subject with a partner who is a FOCBP unwilling to use an effective form of contraceptives (e.g., barrier, hormonal, oral, transdermal, implant, injection, or abstinence) for either themselves or their partner, as appropriate, for the duration of the study. -",true,"ALL","18 Years","49 Years",{"count":21,"type":22},36,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","The purpose of this trial is to determine the safety of IVMED-85 eye drops in healthy adult subjects. Participants will be assigned to either the active or vehicle eyedrop group. The participants will receive eye drops twice daily for 6 weeks. Participants will not know which eyedrop they are taking.",[28],"Safety Study",[30,31,32],"eye drops","safety","myopia","RECRUITING","2026-02-04",{"date":36,"type":37},"2026-02-05","ACTUAL",{"date":34,"type":37},{"date":40,"type":22},"2026-07",{"name":42,"class":43},"iVeena Delivery Systems, Inc.","INDUSTRY",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":17,"minAge":52,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":23,"phases":56,"briefSummary":58,"conditions":59,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":4},"100497788","phase-1-efficacy-of-ivmed-85-on-pediatric-myopia-100497788","NCT05761795","Efficacy of IVMED-85 on Pediatric Myopia","A Randomized, Controlled, Double-Masked Adaptive Design Evaluation of the Safety and Preliminary Efficacy of IVMED-85 on Pediatric Myopia","Inclusion Criteria:\n\n* To be considered for enrollment in the study, the patient must meet all of the following criteria:\n\n  1. Age 5 to 16 years and 6 months, three age groups cohorts (5-8), (9-12), and (13-16) (Phase 1 patients will be exclusively age 13-16).\n  2. Refractive error by cycloplegic refraction in both eyes: myopia -0.75 D to -9.75 D spherical equivalent; astigmatism ≤ 4.00D; anisometropia \\\u003C3.00 D\n  3. Best corrected distance visual acuity better than or equal to Snellen 20\u002F40 (logMAR equivalent 0.3) in both eyes\n  4. Kmax \\>40 D and \\\u003C50 D in both eyes\n  5. Minimum corneal thickness \\> 350 microns in both eyes\n  6. Absence of ocular comorbidities (glaucoma, cataract, anterior segment dysgenesis, corneal scarring, juvenile rheumatoid arthritis, lens subluxation, uveitis, collagen disorders (Ehlers-Danlos, Marfan's syndrome, osteogenesis imperfecta, retinal diseases) in both eyes\n  7. Written informed consent from a parent or legal guardian and assent from participant\n  8. Willing and able to comply with clinic visits and study-related procedures.\n\n     Exclusion Criteria:\n\nA patient who meets any of the following criteria, in either eye, will be excluded from the study:\n\n1. Current or previous myopia treatment with atropine, pirenzepine, or other topical anti-muscarinic\n2. Significant central corneal scarring or hydrops\n3. Known copper allergy\n4. Use of rigid gas permeable lenses, including orthokeratology lenses within 90 days of screening\n5. Previous cornea, glaucoma, eyelid, strabismus (exotropia or esotropia) or intraocular surgeries\n6. Prior history of ocular disorder (e.g., current or prior history of strabismus (exotropia or esotropia), amblyopia, glaucoma, cataract, retinal detachment or nystagmus, or abnormality of the cornea, lens, iris, ciliary body, or central retina)\n7. Myopic degeneration with potential visual acuity worse than Snellen 20\u002F40 (logMAR equivalent 0.3)\n8. Intraocular pressure \\>26 mmHg\n9. Medical conditions pre-disposing patient to degenerative myopia or abnormal ocular refractive anatomy (e.g., Stickler Syndrome, Down Syndrome, osteogenesis imperfecta, Ehler's-Danlos Syndrome, Retinopathy of Prematurity)\n10. Participation in a clinical trial with use of any investigational drug or treatment within 30 days prior to Visit 1\n11. Employees of the study site or their immediate families\n12. Pregnancy\n13. Hypothyroidism or hyperthyroidism\n14. Patient less than 17 Kg weight\n15. Planned ophthalmic surgery during the study","5 Years","16 Years",{"count":55,"type":22},216,[25,57],"PHASE2","The goal of this clinical trial is to evaluate the safety and preliminary efficacy of a 1-year course of IVMED-85 eye drops for the treatment of pediatric myopia by assessing its safety effects on visual acuity and its effect on the change and\u002For progression of myopia.\n\nThe main question\\[s\\] it aims to answer are:\n\n* Does IVMED 85 improve visual acuity\n* Does IVMED 85 slow or otherwise change the progression of myopia\n\nParticipants will use eyedrops twice a day for one year. Researchers will compare IVMED 85 to a placebo.",[60],"Myopia, Progressive","NOT_YET_RECRUITING","2023-09-27",{"date":64,"type":37},"2023-09-29",{"date":66,"type":22},"2024-02",{"date":68,"type":22},"2026-12",{"name":42,"class":43},""]