[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"dry-eyes-chronic\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:dry-eyes-chronic":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,44,69],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":4},"100585534","phase-3-phase-iii-study-of-topical-fibrinogen-depleted-human-platelet-lysate-compared-to-placebo-for-moderate-to-severe-dry-eye-100585534",false,"NCT06903611","Phase III Study of Topical Fibrinogen-Depleted Human Platelet Lysate Compared to Placebo for Moderate to Severe Dry Eye","CAMOMILE-2: Phase III Randomized, Double-Masked, Safety and Efficacy Study of Topical Fibrinogen-Depleted Human Platelet Lysate Compared to Vehicle Control for the Treatment of Moderate to Severe Dry Eye","CAMOMILE-2","Inclusion Criteria:\n\n1. Male or female subjects who at the time of consent are 18 years of age or older, if participating at a study site located in the U.S.\n2. Having a self-reported history of dry eye disease within the past 6 months.\n3. NEI Corneal Fluorescein Staining Score in at least one eye at screening and at Day 0 (pre-randomization) that is ≥ 6 (total score)as determined by the investigator.\n4. Visual Analog Scale (VAS) Symptom Index-Eye Dryness\u002FEye Discomfort total score (pre-dose) that is ≥ 40 points at screening and at Day 0 (pre-randomization).\n5. Willingness to have both the right and left eyes treated in the study.\n6. Willingness to discontinue contact lenses and all current DED treatments except artificial tears.\n7. Be able to demonstrate ability to use study medication bottle; this can be documented on study bottle used during washout period.\n8. Female subjects must be either: (1) of non-childbearing potential; or, (2) of childbearing potential and using an acceptable method of birth control with a negative pregnancy test :\n\n   1. Females of Non-childbearing Potential: Surgically sterilized (e.g., hysterectomy or bilateral oophorectomy) prior to screening; or, post-menopausal (i.e., no menstrual bleeding for at least 1 year prior to screening; or with a negative pregnancy test if less than 1 year post-menopausal).\n   2. Females of Childbearing Potential: Must agree to use a highly effective acceptable form of birth control (e.g., established hormonal birth control, or double barrier method: intrauterine device plus condom or spermicidal gel plus condom) from 21 days prior to dosing until 7 days after dosing.\n9. Providing written Informed Consent consistent with privacy language as per national regulations (e.g., HIPAA authorization) with signature obtained from the subject or legally authorized representative prior to the performance of any study related procedures (including withdrawal of prohibited medication.\n10. Willingness and ability to comply with schedule for follow-up visits and postoperative evaluations.\n\n    \\-\n\nExclusion Criteria:\n\n* Subjects who meet any of the following exclusion criteria for one or both eyes at screening will not be enrolled in the study. Subjects who meet any of the following exclusion criteria for one or both eyes on Day 0 will not be randomized and will be withdrawn from the study as screen failures:\n\n  1. Any abnormal lid anatomy or blinking function in either eye.\n  2. Using any topical ocular treatment other than the following medications:\n\n     a. Artificial Tears: Preservative-free artificial tears may be used as needed before and\u002For during the study. Whenever practicable, the same brand of artificial tears should be used throughout the study and its use documented in the patient diary throughout study participation.\n  3. Previous ocular surgery of any type (including lacrimal, corneal and trauma), except:\n\n     1. Non-refractive laser eye surgery of any type in either eye performed more than 3 months before screening is permitted.\n     2. Refractive surgery in either eye performed more than 6 months before screening is permitted.\n     3. Cataract surgery in either eye performed more than 3 months before screening is permitted\n  4. Any ocular anomaly that, in the investigator's opinion, interferes with the ocular surface, including:\n\n     1. Active ocular herpes simplex virus infection\n     2. Recurrent corneal erosion\n     3. Symptomatic epithelial basement membrane dystrophy\n     4. Mucus fishing syndrome\n     5. Giant papillary conjunctivitis\n     6. Post-radiation keratitis\n     7. Stevens-Johnson syndrome\n     8. Corneal ulcer\n     9. Abnormalities of the nasolacrimal drainage system\n     10. Chemical injury\n     11. Diagnosed significant anterior blepharitis and\u002For progressive pterygium\n  5. Current history of ocular infection (viral, bacterial, fungal), disease or inflammation (e.g., uveitis) not associated with dry eye, unless the disorder or disease is, in the investigator's opinion:\n\n     1. Stable for at least 3 months before the Screening Visit; and,\n     2. Not likely to impact or possibly interfere with the interpretation of study results.\n  6. Subjects with a current intraocular infection or with any other current eye or systemic condition (e.g., severe endothelial corneal dystrophy) that, in the investigator's opinion, would interfere with the dry eye evaluation or treatment, or for which the potential benefits of CAM-101 do not outweigh the risks.\n  7. History of ocular allergy (including seasonal conjunctivitis) or chronic conjunctivitis other than that secondary to dry eye.\n  8. Known hypersensitivity to the components of CAM-101 or the vehicle control (fibrinogen-depleted human platelet lysate; Plasma-Lyte A).\n  9. Known hypersensitivity to one of the procedural medications (e.g., proparacaine, fluorescein) unless a suitable alternative medication is available.\n  10. Inability to refrain from contact lens wear during the study, including the vehicle control run-in period.\n  11. Anticipated need for temporary or permanent punctum plugs during the study. (If punctum plugs have been in place for at least 4 weeks prior to the screening visit, the plugs are allowed to remain in place during the study. ) Patients must remain symptomatic for DED post punctal plug insertion.\n  12. Any ocular disease or ocular condition not stabilized within 1 month (30 days) before the screening visit.\n  13. Any clinically significant systemic disease or condition that is inadequately controlled (e.g., diabetes, thyroid disease, autoimmune disease) or not stabilized within 4 weeks before the screening visit.\n  14. Inability or unwillingness to discontinue use of autologous serum eye drops or platelet rich plasma eye drops during the 2-week run-in period and throughout the remainder of the study.\n  15. Female subjects who are pregnant or lactating or plan to become pregnant during the course of the study.\n  16. Subjects not under legal guardianship who, in the investigator's opinion, lack the mental capacity to provide written informed consent for study participation.",true,"ALL","18 Years",{"count":21,"type":22},475,"ESTIMATED","INTERVENTIONAL",[25],"PHASE3","Prospective, multicenter, randomized, vehicle-controlled, double-masked, study of CAM-101 topical ophthalmic solution compared to vehicle control followed by crossover to long-term follow-up open-label treatment with CAM-101 for one year.",[28,29,30,31],"Dry Eye Disease","Dry Eye","Dry Eyes Chronic","Dry Eye Syndromes","NOT_YET_RECRUITING","2026-06-11",{"date":35,"type":36},"2026-06-12","ACTUAL",{"date":38,"type":22},"2026-10-01",{"date":40,"type":22},"2028-12",{"name":42,"class":43},"Cambium Bio Limited","INDUSTRY",{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":51,"enrollmentInfo":52,"targetDuration":4,"studyType":23,"phases":54,"briefSummary":56,"conditions":57,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":4},"100613506","phase-4-switching-from-xiidra-to-tryptyr-100613506","NCT07267481","Switching From Xiidra to TRYPTYR","Efficacy of Switching Participants Treated With Xiidra to TRYPTYR","Inclusion Criteria:\n\n* Adults ≥18 years of age.\n* Have a history of DED for at least the past 6 months.\n* Are currently using Xiidra as directed by their eye care provider for ≥1 month.\n* Are symptomatic as determined with SPEED (≥7) and have an abnormal Schirmer test score \\[≥2 to \\\u003C10 mm\u002F5 min\\]) at Screening\u002FBaseline. If Shirmer only qualifies for one eye, that will be the study eye. If Shirmer qualifies for both eyes, the right eye will be the study eye.\n* Have corrected distance visual acuity of 20\u002F40 or better.\n* Willing to discontinue contact lens wear 24 hours prior to screening visit and throughout the study.\n\nExclusion Criteria:\n\n* Have a systemic health condition that is known to alter tear film physiology (e.g., primary and secondary Sjögren's syndrome).\n* Have a history of ocular surgery within the past 12 months.\n* Have a history of severe ocular trauma, active ocular infection or inflammation that is not dry eye related.\n* Punctal plugs in place for \\\u003C 3 months and\u002For Lacrifill in place for \\> 5 months.\n* Have ever used Accutane\n* Currently using ocular medications, including topical anti-inflammatory drops, (other than Xiidra) 1 month prior to enrollment\n* Any artificial tear use at enrollment must remain consistent throughout the study.\n* Are pregnant or breast feeding.\n* Have had a physical meibomian gland treatment withing 1 month of enrollment.\n* Initiated, discontinued or changed dose of a systemic medication known to cause ocular drying (e.g., antihistamines or tricyclic antidepressants) within 14 days of the screening visit.\n* Have a condition or be in a situation, which in the investigator's opinion, may put the participant at significant risk, may confound the results, or may significantly interfere with their study participation.","99 Years",{"count":53,"type":22},100,[55],"PHASE4","To determine the efficacy of switching participants who are being treated with Xiidra to acoltremon 0.003%.\n\nHypothesis: Switching to acoltremon 0.003% will greatly improve the signs and symptoms of participants who were being treated with Xiidra at 28 days post-treatment compared to baseline.",[29,30,31,58],"Eye Diseases","2025-11-25",{"date":61,"type":36},"2025-12-05",{"date":63,"type":22},"2025-12-15",{"date":65,"type":22},"2026-05-01",{"name":67,"class":68},"Southern College of Optometry","OTHER",{"id":70,"slug":71,"hasResults":11,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":4,"eligibilityCriteria":75,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":76,"targetDuration":4,"studyType":23,"phases":78,"briefSummary":80,"conditions":81,"keywords":4,"overallStatus":32,"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.",{"count":77,"type":22},32,[79],"PHASE1","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®.",[29,30,31],"2025-03-18",{"date":84,"type":36},"2025-03-19",{"date":86,"type":22},"2025-12-30",{"date":88,"type":22},"2026-12-30",{"name":90,"class":43},"Laboratorios Sophia S.A de C.V."]