[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100591857":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":29,"locations":25,"responsibleParty":38,"collaborators":40,"id":43,"slug":44,"hasResults":45,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":45,"sex":51,"minAge":52,"maxAge":53,"enrollmentInfo":54,"targetDuration":25,"studyType":57,"phases":58,"briefSummary":60,"conditions":61,"keywords":63,"overallStatus":65,"whyStopped":25,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":25},{"fullName":5,"class":6},"Avizor SA","INDUSTRY",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Contact lens users with eye dryness","OTHER","Contact lens users that have eye dryness symptoms. Both treatments will be administered, as it is a crossover study.",[13,14],"Device: Multidose mosturizing solution DROP 0.4%","Device: Multidose mosturizing solution Avizor Eye Drops 0.2% Preserved",{"label":16,"type":10,"description":17,"interventionNames":18},"Non contact lens user with eye dryness","Non contact lens patients with eye dryness symptoms. Both treatments will be administered, as it is a crossover study.",[13,14],[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","Multidose mosturizing solution DROP 0.4%","Ophthalmic mosturizing solution to be administered 1-4 times per day in both eyes",[9,16],null,{"type":21,"name":27,"description":23,"armGroupLabels":28,"otherNames":25},"Multidose mosturizing solution Avizor Eye Drops 0.2% Preserved",[9,16],[30,35],{"name":31,"role":32,"phone":33,"phoneExt":25,"email":34},"Francisco Blazquez, MD, MsC","CONTACT","(+34) 983184734","fblazqueza@fundacion.uva.es",{"name":36,"role":32,"phone":33,"phoneExt":25,"email":37},"Maria Jesus Gonzalez Garcia, OD, PhD","mariajesus.gonzalez.garcia@uva.es",{"type":39,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR",[41],{"name":42,"class":10},"Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA","100591857","phase-3-clinical-trial-for-the-evaluation-of-safety-and-efficacy-of-drop-04-100591857",false,"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.","ALL","18 Years","99 Years",{"count":55,"type":56},79,"ESTIMATED","INTERVENTIONAL",[59],"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.",[62],"Eye Dryness",[64],"contact lens, dry eye","NOT_YET_RECRUITING","2025-07-04",{"date":68,"type":69},"2025-07-09","ACTUAL",{"date":71,"type":56},"2025-07",{"date":73,"type":56},"2025-12-31",{"name":5,"class":6}]