[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Avizor SA\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":68},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,40],{"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},"100600002","evaluating-the-efficacy-and-safety-of-contact-lens-lubricant-in-rigid-gas-permeable-corneal-contact-lens-wearers-100600002",false,"NCT07091825","Evaluating the Efficacy and Safety of Contact Lens Lubricant in Rigid Gas Permeable Corneal Contact Lens Wearers","A Prospective, Multi-center, Open-Label, Randomized Controlled, Non-Inferiority Clinical Study Evaluating the Efficacy and Safety of Contact Lens Lubricant in Rigid Gas Permeable Corneal Contact Lens Wearers","Inclusion Criteria:\n\n1. Aged 8 and older, no gender limitation;\n2. Rigid gas permeable corneal contact lens (OK lens) wearers;\n3. The best corrected distance visual acuity of framed lenses in both eyes can reach 5.0 (5-Point Scale);\n4. Be able and willing to comply with all treatments and follow-ups;\n5. Be able to understand the purpose of the trial, participate voluntarily and have ICF signed by the subject himself\u002Fherself or his\u002Fher legal guardian.\n\nExclusion Criteria:\n\n1. Patients with only one eye meeting the inclusion criteria.\n2. Patients with abnormal clinical abnormalities or systemic diseases affecting the eyes that occurred or is occurring before screening and, in the investigator's judgment, preclude the use of corneal contact lenses.\n3. Patients with some eye diseases that affect contact lens wearing: such as acute or chronic eye diseases, conjunctivitis catarrhalis aestiva, glaucoma, corneal abnormalities, keratoconus, etc.\n4. Patients with allergies to the components of contact lens or contact lens care solution involved in this trial;\n5. Patients who are using or need to use drugs that may cause dry eyes or affect vision and corneal curvature (e.g. immunosuppressant, glucocorticoids, IOP-lowering drugs, low concentration atropine) during the study;\n6. Patients with a history of intraocular operation;\n7. Patients with abnormal IOP (the single eye IOP \\\u003C10 mmHg or \\>21mmHg, or the IOP difference of both eyes \\>5mmHg), obvious fundus abnormalities, examination of corneal endothelial cell (abnormal ≥ Level 4), or slit-lamp examination abnormalities.\n8. Patients with dry eye syndrome or with break up time (BUT) \\\u003C5s.\n9. Subjects who participated in other drug clinical trials within 90 days before screening, and participated in other medical device clinical trials within 30 days;\n10. Patients who wore rigid contact lens (including orthokeratology lens) within the past 30 days;\n11. Patients who are pregnant, nursing or planning to conceive at the enrollment;\n12. Patients with contraindications for wearing rigid contact lenses or unsuitable for wearing rigid contact lenses as indicated by examination results;\n13. Other conditions for which the investigator judged the patient unsuitable for inclusion.","ALL","8 Years",{"count":19,"type":20},152,"ESTIMATED","INTERVENTIONAL",[23],"NA","This trial aims to evaluate the safety and effectiveness of LACRIFRESH OCU-DRY 0.3% OSD, a contact lens lubricant produced by AVIZOR, S.A. This clinical trial adopts a Multi-center, randomized, open-label, positive parallel-controlled design in accordance with the principles outlined in the Norms on the Quality Management for the Clinical Trials of Medical Devices issued by the National Medical Products Administration of China.\n\nMeanwhile, following statistical requirements, 152 rigid contact lens wearers are planned to be enrolled after screening and meeting the inclusion criteria. Participants will be randomly assigned to groups and provided with lenses, lubricants, and care solutions accordingly. Clinical follow-up assessments are scheduled at 1 week, 1 month, and 3 months after use.\n\nThe primary efficacy indexes are the percentage of patients with binocular comfort score ≥ Level 3 at the 1-month follow-up and the percentage of patients with best corrected distance visual acuity with contact lenses for both eyes ≥5.0 at the 1-month follow-up after using the contact lens lubricant. Secondary efficacy indexes include, best corrected distance visual acuity with lenses, visual acuity with lenses, residual diopter, tear break-up time, uncorrected visual acuity, examination of contact lens fitting status, lens assessment, and contact lens lubricant evaluation during the corresponding follow-up periods. Safety indexes include slit lamp examination, fundus examination, IOP, corneal endothelial cell, adverse events, serious adverse events, device defects that may lead to serious adverse events, other device defects during the corresponding follow-up periods.",[26],"Myopia","RECRUITING","2025-07-21",{"date":30,"type":31},"2025-07-29","ACTUAL",{"date":33,"type":31},"2025-06-27",{"date":35,"type":20},"2026-06-30",{"name":37,"class":38},"Avizor SA","INDUSTRY",3,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":46,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":48,"maxAge":49,"enrollmentInfo":50,"targetDuration":4,"studyType":21,"phases":52,"briefSummary":54,"conditions":55,"keywords":57,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":4},"100591857","phase-3-clinical-trial-for-the-evaluation-of-safety-and-efficacy-of-drop-04-100591857","NCT06985875","Clinical Trial for the Evaluation of Safety and Efficacy of Drop 0.4%","Clinical Trial for the Evaluation of the Safety and Efficacy of a Moisturizing Solution With Hyaluronic Acid Drop 0.4%","DROP04","INCLUSION CRITERIA:\n\n* Male or female, aged 18 years or older, capable of freely providing informed consent for participation in the study.\n* Signed informed consent form prior to any study-related tests.\n* Signed data protection form prior to any study-related tests.\n\nAdditionally, for Group 1 (Non contact lens users)\n\n* Ocular surface disease index (OSDI) ≥ 13\n* No use of contact lenses in the past month and not planning to use them during the study period.\n\nAdditionally, for Group 2 (contact lens users)\n\n* Contact lens dry eye questionnaire (CLDEQ-8) ≥ 12\n* Contact lens (CL) use with a habitual minimum use of 4 days per week and 4 hours per day in the past month.\n\nEXCLUSION CRITERIA:\n\n* Any active ocular surface disease except for dry eye disease.\n* Severe dry eye, defined as meeting at least one of the following criteria in at least one eye:\n\n  * Corneal fluorescein staining ≥ 4 on the Oxford scale (0-5).\n  * Conjunctival lissamine green staining ≥ 4 on the Oxford scale (0-5).\n  * Schirmer test value ≤ 2 mm.\n  * Tear stability (BUT) of 0 seconds.\n* History of ocular surgery in the last 3 months or refractive corneal surgery in the last 6 months.\n* History of herpetic keratitis or uveitis.\n* History of severe ocular infections or inflammation in the 6 months prior to the study.\n* History of allergies affecting the ocular surface during the study period.\n* Patients who have started or are expected to modify the use of the following topical medications during the study (except for artificial tears\u002Fmoisturizing and lubricating solutions):\n\n  * Calcineurin inhibitors (cyclosporine, tacrolimus, etc.) in the 12 weeks prior to the study.\n  * Corticosteroids or non steroid anti-inflammatory drugs (NSAID) in the 4 weeks prior to the study.\n  * Blood-derived treatments (autologous serum, enriched plasma, etc.), insulin, or amniotic preparations in the week prior to the study.\n* Use of systemic medication with potential effects on the tear film that has been started or modified in the last month or is expected to change during the study.\n* Known sensitivity or intolerance to any of the products used in the study.\n* Subjects with clinically relevant or uncontrolled systemic diseases in the last 3 months that may interfere with study assessments or outcomes.\n* Pregnancy or breastfeeding. Lack of effective contraceptive methods in women of childbearing potential.\n* Participation in a clinical trial within the last 30 days.","18 Years","99 Years",{"count":51,"type":20},79,[53],"PHASE3","The aim of the trial is to compare the safety and efficacy of the moisturizing solution DROP 0.4% with the moisturizing solution AVIZOR EYE DROPS 0.2% PRESERVED in relieving the symptoms of dry eye over one month of use.",[56],"Eye Dryness",[58],"contact lens, dry eye","NOT_YET_RECRUITING","2025-07-04",{"date":62,"type":31},"2025-07-09",{"date":64,"type":20},"2025-07",{"date":66,"type":20},"2025-12-31",{"name":37,"class":38},""]