[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Laboratorios Sophia S.A de C.V.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":133},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,41,66,90,113],{"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":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100625964","phase-1-safety-and-immunogenicity-of-pro-169-in-patients-with-diabetic-macular-edema-100625964",false,"NCT07429474","Safety and Immunogenicity of PRO-169 in Patients With Diabetic Macular Edema","Phase I Clinical Trial to Evaluate Safety by Determining Immunogenicity Following Unilateral Intravitreal Administration of PRO-169 in Patients With Diabetic Macular Edema","Inclusion Criteria:\n\n1. Age ≥ 18 years.\n2. Diagnosis of type 1 or type 2 diabetes.\n3. Ability to provide signed informed consent.\n4. Ability and willingness to comply with scheduled visits, treatment plan, and other study procedures.\n5. All subjects (male and female) who are biologically capable of having children must agree and commit to using a barrier or hormonal contraceptive method (by any route of administration) for the entire duration of the study and for 3 months after the last intravitreal injection.\n6. Female subjects who are biologically capable of having children must have a negative urine pregnancy test at the screening visit.\n7. Best-corrected visual acuity (BCVA) according to the ETDRS chart from 24 to 78 letters (approximate Snellen equivalent of 20\u002F32 to 20\u002F320).\n8. Diabetic macular edema with central involvement evidenced by spectral domain optical coherence tomography (central macular thickness criterion \\> 300 µm for men and \\> 290 µm for women) within 8 days prior to inclusion. All measurements taken on a subject must be taken with an instrument of the same make and model throughout the study.\n9. Meet characteristics that allow for adequate fundus examination (media transparency, adequate pupil dilation).\n10. Glycosylated hemoglobin \\\u003C 12% from a result no older than 3 months.\n\nExclusion Criteria:\n\n1. Chronic kidney disease with renal failure (glomerular filtration rate \\[eGFR\\] \\\u003C15 mL\u002Fmin\u002F1.73 m2) requiring dialysis or transplantation; according to the 2020 Clinical Practice Guideline for the Management of Diabetes in Chronic Kidney Disease from the Kidney Disease Improving Global Outcomes (KDIGO) organization.\n2. Active proliferative diabetic retinopathy in the study eye, including rubeosis iridis, vitreous hemorrhage, or tractional retinal detachment visible during the screening visit.\n3. Individuals who have required initiation of insulin therapy for glycemic control within 4 months prior to the screening visit.\n4. Previous participation in clinical studies with investigational products, ocular or systemic (at least 30 days must have elapsed between the end of participation in a previous trial and inclusion in this study).\n5. Known hypersensitivity or allergy to bevacizumab or any ingredient in the investigational product.\n6. Poorly controlled blood pressure (average of 3 blood pressure readings in a seated position with ≥160 mmHg systolic or ≥100 mmHg diastolic) at the screening visit.\n7. Myocardial infarction or other cardiovascular event (cerebrovascular disease, transient cerebral ischemia, or hospitalization for heart failure) during the 4 months prior to the screening visit, or subjects with active myocardial ischemia.\n8. Systemic treatment with VEGF-related drugs within 4 months prior to the screening visit.\n9. History of any rheumatological or collagen disease of autoimmune origin related to inflammatory processes such as: systemic lupus erythematosus, rheumatoid arthritis, ankylosing spondylitis, Behçet's disease, dermatomyositis, among others.\n10. History of any disease that causes immunosuppression or immunodepression, except diabetes mellitus.\n11. Concomitant use of immunosuppressive agents, immunotherapy, or monoclonal antibodies by any route of administration (other than intravitreal) in the 2 years prior to the screening visit or during the study period.\n12. Subjects who have received intravitreal anti-VEGF treatment (aflibercept, ranibizumab, bevacizumab, faricimab, brolucizumab) in the study eye within 4 months prior to the screening visit.\n13. Use of intraocular or periocular corticosteroids in the study eye within 4 months prior to the screening visit, or use of intravitreal corticosteroid implants at any time.\n14. Use of anticoagulants or antiplatelet agents by any route of administration within 10 days prior to the screening visit or during the study period.\n15. Women of childbearing potential who are pregnant, breastfeeding, or planning to become pregnant during the study period.\n16. Allergy to fluorescein (topical or intravenous) or to anesthetic medications used during the injection procedure.\n17. Subjects with non-diabetic macular edema.\n18. Lens opacities that, according to the LOCS III (Lens Opacities Classification System) classification, exceed one or more of the following criteria: nuclear component \\> NO3C3 (opalescence\u002Fcolor), cortical component \\> C2, and posterior subcapsular component \\> P1.\n19. History of eye surgery (cataract extraction, any intraocular surgery, aphakia, etc.) or panretinal photocoagulation within 3 months prior to the screening visit or planned within the study period.\n20. Intraocular pressure greater than 21 mmHg in the selected eye, measured by Goldmann tonometry at the screening visit.\n21. Presence of macular ischemia or significant perifoveal capillary loss (increase in foveal avascular zone greater than 350 µm) demonstrated by fluorescein retinal angiography (during the screening visit or in a study performed within 4 months prior to the screening visit).\n22. History of YAG capsulotomy in the study eye within 30 days prior to the screening visit.\n23. Evidence of external eye infections, intraocular inflammation, or significant ocular surface disease in either eye within 30 days prior to the screening visit.\n24. History of uveitis in the study eye.\n25. History of retinal detachment, vitrectomy, any type of filtering surgery, corneal transplant, or corneal dystrophy in the selected eye.\n26. Advanced glaucoma or optic neuropathy in the selected eye.\n27. Having only one functional eye (best corrected visual acuity of finger counting or less in the eye with the worst vision).\n28. Having previously participated in this same study.\n29. Being or having an immediate family member (e.g., parent\u002Flegal guardian or sibling) who is part of the research site staff or sponsor.\n30. Subjects with conditions that make it difficult or impossible to draw blood, such as veins that are difficult to see or feel, venous thrombosis in the area where the sample is taken, severe edema, or any other criteria determined by the personnel responsible for performing this procedure.\n31. Difficulty interpreting the optotypes on the ETDRS chart.","ALL","18 Years",{"count":19,"type":20},60,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","Phase I, prospective, interventional, open-label, multicenter clinical trial to evaluate the safety of intravitreal PRO-169 through the presence of serum anti-drug antibodies (ADAs) to bevacizumab.",[26,27],"Immunogenicity","Anti-drug Antibodies (ADAs)","NOT_YET_RECRUITING","2026-03-11",{"date":31,"type":32},"2026-03-13","ACTUAL",{"date":34,"type":20},"2026-03-01",{"date":36,"type":20},"2026-12-15",{"name":38,"class":39},"Laboratorios Sophia S.A de C.V.","INDUSTRY",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":21,"phases":51,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":65},"100616467","phase-3-pro-232-in-patients-subjected-to-cataract-surgery-100616467","NCT07305987","PRO-232 in Patients Subjected to Cataract Surgery","Phase III Clinical Study, to Evaluate the Efficacy and Safety of PRO-232 Ophthalmic Solution on the Ocular Surface of Patients Postoperative to Cataract Surgery by Phacoemulsification.","PRO-232","Inclusion Criteria:\n\n* To have the ability to voluntarily grant their signed informed consent (FCI).\n* Being able and willing to comply with scheduled visits in the treatment plan and other study procedures.\n* Being 18 years of age or older.\n* Male or female.\n* Women within childbearing age who do not have a history of bilateral tubaric obstruction, hysterectomy, or bilateral oophorectomy should ensure continued use (initiated ≥ 30 days prior to signing the ICF) of a hormonal contraceptive method or intrauterine device (IUD) during the study period.\n* Having a postoperative diagnosis (unilateral, single eye) of cataract extraction by phacoemulsification with uncomplicated intraocular lens (IOL) placement\\*\\* on the day prior to inclusion.\n* Having an intraocular pressure ≥ 8 and ≤ 21 mmHg.\n\n  * A complicated cataract surgery will be defined by study, as any procedure where the planned surgical technique has been modified or the use of vitrectomy has been required, an IOL has not been placed, a different IOL from the originally planned model has been placed or an IOL has been placed outside the capsular bag, remains of the lens have been left inside the eye, there was rupture of the posterior capsule with or without the presence of vitreous, or detachment of Descemet's membrane occured, there was disinsertion of the capsular pouch, or there was trauma to the iris or ciliary body during the surgical procedure. In the event of any other situation that could be considered a complication and that is not reflected in this list, the inclusion of said patient will be at the discretion of the researcher.\n\nExclusion Criteria:\n\n* Allergy to any of the components of the investigational products or to any of the compounds used during testing.\n* Surgery on both eyes during the same surgical period.\n* Not having had surgery within a period of 24 hours before inclusion.\n* Performing iridectomy, or injury to the pupillary sphincter during phacoemulsification surgery.\n* History of use of eye drops between the end of surgery and the baseline visit.\n* History of diagnosis of glaucoma or ocular hypertension.\n* History of chronic or recurrent inflammatory eye disease (uveitis, iritis, iridocyclitis, etc.), eye inflammation or pain in the eye of study prior to surgery.\n* Presence of corneal abrasion or ulceration.\n* Use of topical or subconjunctival steroids or nonsteroidal anti-inflammatory drugs (NSAIDs), 24 hours prior to surgery and until the start of instillation of investigational medications.\n* Use of steroids or systemic anti-inflammatory drugs within 14 days prior to surgery or if you plan to use them during the study period, or the presence of a diagnosis requiring the use of these medications during the study period.\n* Use of blood thinners, systemic steroids, or immunomodulators within the past two weeks.\n* Periocular injection of any steroid 4 weeks prior to initiation of investigational drug instillation or depot steroid use 2 months prior to initiation of investigational drug instillation.\n* Presence or suspicion of viral, bacterial or fungal keratitis and\u002For conjunctivitis.\n* Presence or suspicion of endophthalmitis.\n* Presence or suspicion of anterior segment toxic syndrome.\n* Severe corneal edema that does not allow the evaluation of the anterior chamber.\n* Any disease or condition that requires the use of steroids by any route other than topical ophthalmic application.\n* Patients with a single functional eye.\n* Any condition or disease that, in the opinion of the main investigator, does not make the patient suitable for the study.\n* Having participated in any investigational clinical study 30 days prior to inclusion in this study.\n* Having previously participated in this same study.\n* Having an active inflammatory or infectious disease at the time of study entry.\n* Having unresolved eye injuries or trauma at the time of study entry.\n* Use of antibacterial, antiviral, or antifungal agents by any route of administration within 30 days prior to study enrollment (including intracameral transsurgical antibiotics or administered to irrigation solution), or during the study.\n* Use of pilocarpine and prostaglandin analogues.\n* Secondary implantation or replacement of the intraocular lens (IOL) in the study eye.\n* For women: being pregnant, breastfeeding, or planning to become pregnant within the study period.\n* Be or have an immediate family member (e.g., spouse, parent\u002Flegal guardian, sibling, or child) who is employed by the research site or sponsor, and who is directly involved in this study.",{"count":50,"type":20},134,[52],"PHASE3","The main objective of this study is to evaluate the efficacy and safety of the PRO-232 formulation manufactured by Laboratorios Sophia S.A. de C.V. on the ocular surface of postoperative cataract patients versus a concomitant administration of ophthalmic moxifloxacin and dexamethasone.",[55],"Cataract Extraction","RECRUITING","2025-12-18",{"date":59,"type":32},"2025-12-26",{"date":61,"type":32},"2025-10-27",{"date":63,"type":20},"2026-07-30",{"name":38,"class":39},2,{"id":67,"slug":68,"hasResults":11,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":4,"eligibilityCriteria":72,"healthyVolunteers":73,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":74,"targetDuration":4,"studyType":21,"phases":76,"briefSummary":77,"conditions":78,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":4},"100545268","phase-1-study-to-evaluate-the-safety-and-tolerability-of-pro-190-ophthalmic-solution-compared-to-systane-ultra-on-the-ocular-surface-100545268","NCT06379685","Study to Evaluate the Safety and Tolerability of PRO-190 Ophthalmic Solution Compared to Systane Ultra® on the Ocular Surface.","Phase I Clinical Study to Evaluate the Safety and Tolerability of PRO-190 Ophthalmic Solution Compared to Systane Ultra® 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* 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* No history of contact lens wear\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 ied consent form \\[ICF\\]) of the use of a hormonal contraceptive method or intrauterine device (IUD) during the study period.\n* Having vital signs within normal parameters.\n* Best corrected visual acuity (BCVA) of 20\u002F30 or better in both eyes.\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* 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\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,{"count":75,"type":20},32,[23],"This is a phase I clinical study to evaluate the safety and tolerability of PRO-190 ophthalmic solution through the incidence of unexpected adverse events, changes in Best Corrected Visual Acuity (BCVA), changes in ocular surface integrity, changes in the ocular comfort index (OCI) score, and IOP measurement compared to Systane Ultra®.",[79,80,81],"Dry Eye","Dry Eyes Chronic","Dry Eye Syndromes","2025-03-18",{"date":84,"type":32},"2025-03-19",{"date":86,"type":20},"2025-12-30",{"date":88,"type":20},"2026-12-30",{"name":38,"class":39},{"id":91,"slug":92,"hasResults":11,"nctId":93,"briefTitle":94,"officialTitle":95,"acronym":4,"eligibilityCriteria":96,"healthyVolunteers":73,"sex":16,"minAge":97,"maxAge":98,"enrollmentInfo":99,"targetDuration":4,"studyType":21,"phases":101,"briefSummary":102,"conditions":103,"keywords":4,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":106,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":40},"100545990","phase-3-study-to-evaluate-the-efficacy-of-alleance-atropine-sulfate-001-as-a-treatment-to-delay-myopia-and-axial-ocular-elongation-in-children-100545990","NCT06389110","Study to Evaluate the Efficacy of Alleance® (Atropine Sulfate 0.01%) as a Treatment to Delay Myopia and Axial Ocular Elongation in Children.","Phase III Clinical Study to Evaluate the Efficacy of Alleance® (Atropine Sulfate 0.01%) as a Treatment to Delay the Progression of Myopia and Axial Ocular Elongation in Children.","Inclusion Criteria:\n\n* Children aged between 3 to 12 years\n* Male or female sex.\n* The parent(s) or legal guardian(s) must voluntarily give their signed informed consent.\n* From the age of 7 years and older, the subject's willingness to participate in the research study will be expressed in writing. In the case of subjects under 7 years of age, only the signature of the informed consent by the parent(s) or legal guardian(s) will be required, provided that the subject's verbally expressed will is respected.\n* Ability and willingness to comply with the scheduled visits, treatment plan and other study procedures.\n* Female subjects, who have already presented their menarche, must have a negative urine pregnancy test at the time of screening.\n* Female subjects who have already experienced menarche should secure a method of contraception for the duration of the study. Acceptable contraceptive methods include abstinence (defined as abstinence from heterosexual intercourse from study entry until completion) or use of a highly effective contraceptive method, including hormonal contraception, barrier methods or intrauterine device).\n* Refractive error of spherical equivalent between -0.50 to -6.00 D in each eye, measured by autorefraction and cycloplegic retinoscopy.\n* Astigmatism less than -1.50 D in each eye, measured by autorefraction and retinoscopy.\n* Spherical equivalent anisometropia ≤ 1.50 D measured by autorefraction and cycloplegic retinoscopy.\n* Best corrected visual acuity (BCVA) normal for age.\n* Normal binocular function and stereopsis for age.\n* Normal intraocular pressure (\\\u003C 21 mmHg).\n* Gestational age ≥ 32 weeks and birth weight \\> 1500 g.\n\nExclusion Criteria:\n\n* Allergy to atropine or any of the components of the investigational products.\n* Previous or current use of atropine, orthokeratology lens or other optical methods for myopia control (bifocal, progressive, multifocal, or defocusing air or contact lenses). Only prior or current use of frame lenses or monofocal contact lenses for the correction of myopic or myopic\u002Fastigmatic refractive error will be allowed.\n\nHistory or current history of amblyopia or manifest strabismus, including intermittent tropia.\n\n* Heart rate \\> 120 beats per minute persistently (for more than 10 minutes) at the time of screening\u002Fbaseline visit.\n* History of any disease or syndrome predisposing the subject to severe myopia (Marfan syndrome, Stickler syndrome, retinopathy of prematurity, etc.).\n* History of serious systemic disease that, in the investigator's judgment, would make the subject ineligible (e.g., cardiac, endocrine, respiratory, neurologic \\[infantile cerebral palsy\\], Down syndrome, etc.).\n* History or current history of glaucoma or ocular hypertension.\n* History of any refractive ocular anatomical anomaly (keratoconus, lenticonus, spherophakia, aphakia, etc.).\n* History of ocular diseases, excluding myopia (corneal alterations\u002Fopacities, cataract, retinal alterations, inflammatory diseases, etc.).\n* History of any type of ocular surgery.\n* For female subjects who have presented their menarche: being pregnant or breastfeeding.\n* Having participated in clinical research studies 30 days prior to inclusion in the present study.\n* Previous participation in this study.\n* Present unresolved ocular lesions or trauma at the time of study entry.\n* Present active inflammatory or infectious ocular disease at the time of study entry.\n* Having undergone surgical procedures, not ophthalmologic, within the last 3 months.\n* Chronic use of any topical or systemic antimuscarinic\u002Fanticholinergic medication (atropine, scopolamine, tropicamide) within 21 days prior to screening, and\u002For anticipated need for its chronic use during the study period (more than 7 consecutive days in a month or more than 30 days total in a year). The use of cycloplegic drops for ophthalmologic examination is allowed.\n* Be or have an immediate family member (e.g., parent\u002Flegal guardian or sibling) who is part of the research site or sponsor´s staff.\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.","3 Years","12 Years",{"count":100,"type":20},123,[52],"Phase III clinical study to evaluate the efficacy of Alleance® (atropine sulfate 0.01%) ophthalmic solution through the incidence of unexpected adverse events, changes in Best Corrected Visual Acuity (BCVA), changes in intraocular pressure, changes in the amplitude of accommodation, compared to placebo, as a treatment to delay the progression of myopia and axial ocular elongation in children.",[104,105],"Myopia","Myopia, Progressive",{"date":107,"type":32},"2025-03-21",{"date":109,"type":32},"2025-03-15",{"date":111,"type":20},"2027-10-30",{"name":38,"class":39},{"id":114,"slug":115,"hasResults":11,"nctId":116,"briefTitle":117,"officialTitle":118,"acronym":4,"eligibilityCriteria":119,"healthyVolunteers":73,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":120,"targetDuration":4,"studyType":21,"phases":121,"briefSummary":122,"conditions":123,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":127,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":4},"100544934","phase-1-study-to-evaluating-pro-240-ophthalmic-solution-compared-to-optive-100544934","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.",{"count":75,"type":20},[23],"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®.",[124,125,126],"Dry Eye Disease","Dry Eye Sensation","Ocular Surface Disease",{"date":84,"type":32},{"date":129,"type":20},"2026-01-30",{"date":131,"type":20},"2027-01-30",{"name":38,"class":39},""]