[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Boston Sight\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":65},{"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":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":26,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":4},"100636112","phase-4-demodex-blepharitis-in-scleral-lens-wearers-100636112",false,"NCT07561450","Demodex Blepharitis in Scleral Lens Wearers","Inclusion Criteria:.\n\n1. Written Informed Consent has been obtained prior to any study-related procedures taking place\n2. Subject is Male or Female, 18 years of age or older prior to the initial visit\n3. Is an established wearer of PROSE devices for \\> 6 months in both eyes\n4. Currently wears PROSE devices on a daily basis in both eyes\n5. No plans to alter the PROSE lens design in either eye during the study period\n6. Bilateral Demodex Blepharitis (\\> Grade 2, which is more than 10 upper lash collarettes, worse eye)\n7. Baseline CLDEQ-8 score of 12 or higher\n8. Baseline VAS score of 40 or above for frequency OR severity in ONE of the following:\n\ntolerability, blurred vision, ocular burning, ocular redness or ocular itching 9. In the opinion of the investigator, the subject can follow study instructions 10. In the opinion of the investigator, the subject can complete all study procedures and visits\n\n\\-\n\nExclusion Criteria:\n\n1. Is currently participating in any other type of eye-related clinical research study\n2. Is pregnant or nursing as reported by the subject.\n3. Has a condition or is in a situation which, in the investigator's opinion, may put the subject at significant risk, may confound study outcomes, or may significantly interfere with the subject's participation in the study.\n4. Has had previous ocular surgery within the past 12 weeks or has planned ocular surgery during the study period.\n5. Has initiated any new blepharitis or ocular surface treatment within the last 12 weeks\n6. The subject is only wearing a PROSE device in one eye.\n7. The participant is monocular\n8. The participant carries a diagnosis of glaucoma or ocular hypertension or glaucoma suspect AND is currently using glaucoma medications\n9. Allergy to sodium fluorescein\n10. Allergy to XDEMVY (lotilaner ophthalmic solution) 0.25%\n\n    \\-","ALL","18 Years",{"count":18,"type":19},5,"ESTIMATED","INTERVENTIONAL",[22],"PHASE4","The purpose of this study will be to see if Xdemvy (lotilaner ophthalmic solution) 0.25% has a positive impact on ocular surface symptoms and PROSE device functionality and performance.\n\nThe investigators hypothesize the use of Xdemvy in subjects utilizing PROSE treatment will be well tolerated and that the reduction in Demodex mite load on the eyelid margin will result in reduced ocular surface symptoms and improved PROSE tolerance and functionality.",[25],"Demodex Blepharitis",[27],"Blepharitis","NOT_YET_RECRUITING","2026-04-28",{"date":31,"type":32},"2026-05-01","ACTUAL",{"date":34,"type":19},"2026-04-27",{"date":36,"type":19},"2027-02",{"name":38,"class":39},"Boston Sight","OTHER",{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":15,"minAge":4,"maxAge":4,"enrollmentInfo":47,"targetDuration":4,"studyType":49,"phases":4,"briefSummary":50,"conditions":51,"keywords":53,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":64},"100607989","the-effect-of-prose-or-scleral-lenses-on-mental-health-100607989","NCT07195721","The Effect of PROSE or Scleral Lenses on Mental Health","The Effect of PROSE Treatment on Mental Health","Inclusion Criteria:\n\n1. Written Informed Consent has been obtained prior to any study-related procedures taking place.\n2. Subject is Male or Female, 18 years of age or older prior to the initial visit.\n3. Patient is proceeding with a PROSE or scleral lens consultation in one or both eyes for the primary diagnosis of ocular surface disease, including but not limited to Ocular Graft vs Host Disease, Keratoconjunctivitis Sicca, Dry eye, Sjogren's Disease, Rheumatologic ocular surface disease, Exposure Keratitis, Limbal Stem Cell Deficiency, Steven Johnson Syndrome, Mucous Membrane Pemphigoid (Ocular Cicatricial Pemphigoid), Atopic Keratoconjunctivitis, Chemical injury.\n4. Baseline PHQ-9 score \\> 4\n5. Baseline OSDI score of 13 or greater\n6. In the opinion of the investigator, the subject can follow study instructions, complete all study procedures and visits\n7. Is able to understand the English language in verbal and written interactions -\n\nExclusion Criteria:\n\n1. Is currently participating in any other type of eye-related clinical research study that in the opinion of the investigator would interfere with the study\n2. Is pregnant or nursing as reported by the subject.\n3. Has a condition or is in a situation which, in the investigator's opinion, may put the subject at significant risk, may confound study outcomes, or may significantly interfere with the subject's participation in the study.\n4. Recently started medication or other therapeutic treatments for affective mood disorders (such as depression) within the last 8 weeks.\n5. Recently started new treatment for ocular surface disease, including but not limited to topical medicated drops, procedures, punctal plugs within the last 8 weeks.\n6. Ocular surgery within the last 8 weeks\n7. Planned ocular surgery within the study period\n8. Has a known allergy to topical ophthalmic sodium fluorescein dye\n9. Has a known intolerance to topical ophthalmic normal saline\n10. Neurotrophic Keratitis\n11. Corneal ectasia\n12. PROSE or scleral lens wearer within the last 1 year prior to Visit 1 \\[subjects who have solely tried a PROSE or scleral lens in an office setting consultation (and were never dispensed for home use) ARE eligible for enrollment, regardless of whether it occurred in the last year\\]\n13. Is an employee of BostonSight or an employee of a site performing the study -",{"count":48,"type":19},200,"OBSERVATIONAL","The goal of this prospective clinical trial is to evaluate the effect that prosthetic replacement of the ocular surface ecosystem (PROSE, BostonSight, Needham MA) treatment may have on mental health, particularly affective mood disorders. Correlation between changes in mental health and ocular symptom improvement and\u002For visual function improvement will be evaluated.",[52],"Depression - Major Depressive Disorder",[54],"PROSE - prosthetic replacement of the ocular surface ecosystem","RECRUITING","2025-12-30",{"date":58,"type":32},"2026-01-05",{"date":60,"type":32},"2024-11-11",{"date":62,"type":19},"2029-10-31",{"name":38,"class":39},1,""]