[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"dry-eye-sensation\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:dry-eye-sensation":28},{"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":16,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":4},"100544934","phase-1-study-to-evaluating-pro-240-ophthalmic-solution-compared-to-optive-100544934",false,"NCT06375343","Study to Evaluating PRO-240 Ophthalmic Solution Compared to Optive®","Phase I Clinical Study to Evaluate the Safety and Tolerability of PRO-240 Ophthalmic Solution Compared to Optive® on the Ocular Surface of Ophthalmologically and Clinically Healthy Volunteers","Inclusion Criteria:\n\n* Having the ability to voluntarily give their signed informed consent.\n* Ophthalmologically and clinically healthy subjects.\n* Being able to and willing to comply with scheduled visits, treatment plan, and other study procedures.\n* Age ≥18 years.\n* Male or female gender.\n* Women of childbearing potential who have not undergone Bilateral Tubal Occlusion (BTO \\[Tubal Ligation\\]), hysterectomy, or bilateral oophorectomy must ensure continuation (initiated ≥ 30 days prior to signing the informed consent form \\[ICF\\]) of the use of a hormonal contraceptive method or intrauterine device (IUD) during the study period.\n* Best corrected visual acuity (BCVA) of 20\u002F30 or better in both eyes.\n* Corneal staining ≤ grade I on the Oxford Scale.\n* Having an intraocular pressure ≥ 10 and ≤ 21 mmHg.\n\nExclusion Criteria:\n\n* History of hypersensitivity to any of the components of the drugs under investigation.\n* Use of ophthalmic medications from any pharmacological group.\n* Use of medications by any other route of administration.\n* Use of non-steroidal anti-inflammatory drugs, steroid anti-inflammatory drugs, or antibiotics by any route of administration in the last 30 days.\n* History of eye surgery in the last 6 months.\n* Use of contact lenses for a period less than two weeks prior to the start of the study, and during the intervention period of this study.\n* In the case of women: being pregnant, breastfeeding, or planning to become pregnant within the study period.\n* Having participated in any clinical research study 30 days prior to inclusion in this study.\n* Having previously participated in this same study.\n* History of any chronic-degenerative disease, including Diabetes Mellitus or Systemic Arterial Hypertension.\n* Diagnosis of glaucoma or ocular hypertension.\n* Known diagnosis of liver or heart disease.\n* Presenting active inflammatory or infectious disease at the time of entry into the study.\n* Presenting unresolved lesions or traumas at the time of entry into the study.\n* Having been subjected to non-ophthalmological surgical procedures in the last 3 months.\n* Being or having an immediate family member (e.g., spouse, parent\u002Flegal guardian, sibling, or child) who is an employee of the research site or the sponsor, and who directly participates in this study.\n* Active smoking (specified as the consumption of cigarettes regardless of the amount and frequency, 4 weeks prior to study inclusion and during the intervention period of this study).\n* Active alcoholism (specified as the consumption of alcoholic beverages, regardless of the amount and frequency, 72 hours prior to study inclusion and during the intervention period of this study).\n\nElimination Criteria:\n\n* Withdrawal of their consent to participate in the study (informed consent form).\n* Occurrence of a serious adverse event, whether related or not to the interventions, that in the opinion of the principal investigator (PI) and\u002For the sponsor, could affect the patient's fitness to safely continue with the study procedures.\n* Non-tolerability or hypersensitivity to any of the compounds used during the tests -(fluorescein, tetracaine).\n* Non-tolerability or hypersensitivity to any of the drugs under investigation.\n* Adherence \\\u003C 80% determined by the subject's diary and corroborated by the final weight of the research products (RP) compared to the initial weight.",true,"ALL","18 Years",{"count":20,"type":21},32,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","This is a phase I clinical study to evaluating safety and tolerability of PRO-240 ophthalmic solution through the incidence of unexpected adverse events, as well as through changes in Best Corrected Visual Acuity (BCVA), and the incidence of stinging after its administration, compared to Optive®.",[27,28,29],"Dry Eye Disease","Dry Eye Sensation","Ocular Surface Disease","NOT_YET_RECRUITING","2025-03-18",{"date":33,"type":34},"2025-03-19","ACTUAL",{"date":36,"type":21},"2026-01-30",{"date":38,"type":21},"2027-01-30",{"name":40,"class":41},"Laboratorios Sophia S.A de C.V.","INDUSTRY",{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":49,"targetDuration":51,"studyType":52,"phases":4,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":69},"100580758","role-of-corneal-nerves-in-dry-eye-disease-100580758","NCT06841471","Role of Corneal Nerves in Dry Eye Disease","Association Between Corneal Sensitivity, Nerve Morphology, Tear Film Homeostasis and Dry Eye Symptoms","Inclusion Criteria:\n\n* Group with DED: Diagnosis of DED based on the TFOS DEWS II report\n* Group without DED: No diagnosis of DED\n\nExclusion Criteria:\n\n* Exclusion criteria:\n* Systemic disease that may affect ocular health and innervation\n* injury or history of operations on the anterior or posterior segment of the eye, which can affect the corneal structure and physiology\n* regular application of systemic or ocular medication known to affect the tear film except from DED medications\n* eye drops or makeup on the day of measurement.\n\nRemarks:\n\nContact lens wearers are asked not to wear contact lenses for 1 week before the first appointment.\n\nParticipant with DED medications will be asked to use only conservative-free eye drops on the days of examination",{"count":50,"type":21},140,"1 Week","OBSERVATIONAL","This study aims to determine whether corneal nerve function and morphology are affected by tear film instability and ocular surface homeostasis loss. Additionally, it seeks to investigate whether these factors vary based on the severity of dry eye symptoms.",[55,56,28,57],"Dry Eye Disease (DED)","Dry Eye","Corneal Nerve","RECRUITING","2025-03-10",{"date":61,"type":34},"2025-03-11",{"date":63,"type":34},"2025-02-20",{"date":65,"type":21},"2025-12",{"name":67,"class":68},"Daniela Nosch","OTHER",1]