[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07354477":3,"trial-entities:NCT07354477":95,"trial-summary:NCT07354477":101},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":22,"study_type":26,"primary_purpose":27,"phases":28,"enrollment_info":30,"interventions":33,"primary_outcomes":44,"secondary_outcomes":49,"sex":50,"minimum_age":51,"maximum_age":52,"healthy_volunteers":15,"eligibility_criteria":53,"std_ages":69,"locations":72,"central_contacts":82,"overall_officials":88,"references":93,"see_also_links":94},"NCT07354477","QC-111-205","Single-site Pilot Study Evaluating the Effect of QLS-111 Ophthalmic Solution on Posterior Perfusion and Vessel Dilation","An Exploratory, Pilot, Single-site Study to Evaluate the Effect of QLS-111 Ophthalmic Solution on Posterior Perfusion and Vessel Dilation","RECRUITING","2026-09","2026-07","2026-07-06","2026-02-20","Qlaris Bio, Inc.","INDUSTRY",false,"Pilot, single-site, prospective study of QLS-111 0.015 % in subjects with NPDR, OAG or NTG","Pilot, single-site, prospective study of BID OU dosing of QLS-111 0.015 % for 7 days followed by QLS-111 0.075% BID OU in subjects with NPDR, OAG or NTG. Both eyes (OU) will be dosed. The study is comprised of 4 visits including Screening\u002FBaseline visit, 2 Treatment Period visits over 14 days of IP dosing, and a Post-Treatment visit.",[19,20,21],"Non-proliferative Diabetic Retinopathy (NPDR)","Open-angle Glaucoma (OAG)","Normal Tension Glaucoma (NTG)",[23,24,25],"glaucoma","diabetic retinopathy","vessel dilation","INTERVENTIONAL","TREATMENT",[29],"PHASE2",{"count":31,"type":32},14,"ESTIMATED",[34,40],{"type":35,"name":36,"description":37,"armGroupLabels":38},"DRUG","QLS-111 Ophthalmic Solution (0.015%)","QLS-111 (0.015%) administered BID for 7 days OU.",[39],"QLS-111 Ophthalmic Solution, 2 concentrations (0.015% and 0.075%, concurrent) dosed BID for 7 days",{"type":35,"name":41,"description":42,"armGroupLabels":43},"QLS-111 Ophthalmic Solution (0.075%)","QLS-111 (0.075%) administered BID for 7 days OU. Follows the 7 days where QLS-111 (0.015%) is administered.",[39],[45],{"measure":46,"description":47,"timeFrame":48},"Change from Baseline in blood flow to the posterior segment of the eye.","Ocular imaging will be collected at study visits at baseline, treatment period , and 1 week post-treatment and to evaluate change from baseline in retinal vessel diameter and blood flow.","Days 1 through 22",[],"ALL","18 Years",null,{"inclusion":54,"exclusion":58,"raw_text":68},[55,56,57],"Diagnosis of mild to moderate OAG, mild to moderate NTG, or stable NPDR in at least one eye.","Corrected visual acuity in each eye +1.0 logMAR or better by early treatment diabetic retinopathy study (ETDRS) in each eye (equivalent to 20\u002F200).","Able and willing to give signed informed consent and follow study instructions.",[59,60,61,62,63,64,65,66,67],"History of active ocular disease other than mild to moderate OAG, mild to moderate NTG, or stable NPDR.","Patient is using more than 1 ocular hypotensive topical medication for intraocular pressure (IOP) control (prior MIGS and\u002For laser trabeculoplasty to control IOP is allowed if done at least 3 months from Screening (Visit 1).","Use of TO β-blockers (i.e. timolol) within 3 months prior to Screening.","Is noncompliant with current ocular anti-hypotensive medications and\u002For unwilling to be compliant throughout the study.","Clinically significant severe retinal disease in either eye that will require treatment during the study (e.g., proliferative diabetic retinopathy, exudative, or severe non-exudative macular degeneration). NOTE: background diabetic retinopathy (BDR) as required for the NPDR subjects is allowed if in the Investigator's opinion the BDR is stable and is expected to remain stable during the duration of the study.","Anti-VEGF or TO steroid treatment within 3 months prior to Screening or expected treatment while participating in this study. Prior diabetic macular edema (DME) history is allowed if adequately controlled with treatment (anti-VEGFs and steroids not within last 3 months prior to Screening), regimen is stable, and not expected to change during the study. - Corneal pathologic changes preventing reliable measurement (e.g., scarring, opacity, edema, and bullae) in either eye that would inhibit accurate IOP measurements.","Previously diagnosed, clinically significant systemic or psychiatric disease (e.g., myasthenia gravis, hepatic, renal, endocrine, pulmonary, or cardiovascular disorders) which might compromise the study results or subject safety. For the purpose of this study previously diagnosed, clinically significant renal disease that should be excluded from enrollment will be defined as Stages 3-5 kidney disease and\u002For an estimated glomerular filtration rate (eGFR) of ≤59.","Use of calcium channel blockers.","Labile hypertension and\u002For hypotension that is inadequately controlled,","Inclusion Criteria:\n\n* Diagnosis of mild to moderate OAG, mild to moderate NTG, or stable NPDR in at least one eye.\n* Corrected visual acuity in each eye +1.0 logMAR or better by early treatment diabetic retinopathy study (ETDRS) in each eye (equivalent to 20\u002F200).\n* Able and willing to give signed informed consent and follow study instructions.\n\nExclusion Criteria:\n\n* History of active ocular disease other than mild to moderate OAG, mild to moderate NTG, or stable NPDR.\n* Patient is using more than 1 ocular hypotensive topical medication for intraocular pressure (IOP) control (prior MIGS and\u002For laser trabeculoplasty to control IOP is allowed if done at least 3 months from Screening (Visit 1).\n* Use of TO β-blockers (i.e. timolol) within 3 months prior to Screening.\n* Is noncompliant with current ocular anti-hypotensive medications and\u002For unwilling to be compliant throughout the study.\n* Clinically significant severe retinal disease in either eye that will require treatment during the study (e.g., proliferative diabetic retinopathy, exudative, or severe non-exudative macular degeneration). NOTE: background diabetic retinopathy (BDR) as required for the NPDR subjects is allowed if in the Investigator's opinion the BDR is stable and is expected to remain stable during the duration of the study.\n* Anti-VEGF or TO steroid treatment within 3 months prior to Screening or expected treatment while participating in this study. Prior diabetic macular edema (DME) history is allowed if adequately controlled with treatment (anti-VEGFs and steroids not within last 3 months prior to Screening), regimen is stable, and not expected to change during the study. - Corneal pathologic changes preventing reliable measurement (e.g., scarring, opacity, edema, and bullae) in either eye that would inhibit accurate IOP measurements.\n* Previously diagnosed, clinically significant systemic or psychiatric disease (e.g., myasthenia gravis, hepatic, renal, endocrine, pulmonary, or cardiovascular disorders) which might compromise the study results or subject safety. For the purpose of this study previously diagnosed, clinically significant renal disease that should be excluded from enrollment will be defined as Stages 3-5 kidney disease and\u002For an estimated glomerular filtration rate (eGFR) of ≤59.\n* Use of calcium channel blockers.\n* Labile hypertension and\u002For hypotension that is inadequately controlled,",[70,71],"ADULT","OLDER_ADULT",[73],{"facility":74,"status":8,"city":75,"state":76,"zip":77,"country":78,"geoPoint":79},"Stanford University, Dept. of Ophthalmology","Palo Alto","California","94303","United States",{"lat":80,"lon":81},37.44188,-122.14302,[83],{"name":84,"role":85,"phone":86,"email":87},"Lisa Brandano","CONTACT","978-930-2103","lbrandano@qlaris.bio",[89],{"name":90,"affiliation":91,"role":92},"Barbara M Wirostko, MD","Qlaris Bio","STUDY_DIRECTOR",[],[],{"nct_id":4,"conditions":96,"biomarkers":100},[97,98,99],"Low tension glaucoma","Non-Proliferative Diabetic Retinopathy","Open Angle Glaucoma",[],{"nct_id":4,"found":102,"summary":103,"prompt_version":113},true,{"design":104,"status":105,"heading":106,"summary":107,"follow_up":108,"word_count":109,"commitments":110,"compensation":111,"drugs_mentioned":112},"This is a pilot, single-site, prospective study. It is not specified if it is randomized or blinded, and plans to enroll 14 participants.","completed","Pilot Study of QLS-111 for Diabetic Retinopathy and Glaucoma","This pilot study is testing an eye drop called QLS-111 in people with non-proliferative diabetic retinopathy (NPDR), open-angle glaucoma (OAG), or normal tension glaucoma (NTG). The study aims to see how QLS-111 affects blood flow in the back of your eye and whether it helps widen blood vessels. You would use QLS-111 Ophthalmic Solution (0.015%) twice a day for 7 days, followed by QLS-111 Ophthalmic Solution (0.075%) twice a day for another 7 days, in both eyes. The main goal is to measure changes in blood flow to the back of the eye over 22 days. This study is currently unclear on its recruitment status and plans to enroll 14 participants.","The study will measure changes in blood flow to the posterior segment of the eye from Day 1 through Day 22.",111,"You would have 4 visits, including a screening visit, two treatment visits over 14 days, and a post-treatment visit. You would administer QLS-111 eye drops twice daily to both eyes for a total of 14 days.","Not stated in the trial record.",[36,41],"v2"]