Ignite Creation Date:
2025-12-24 @ 10:53 PM
Ignite Modification Date:
2025-12-25 @ 8:22 PM
Study NCT ID:
NCT05495269
Status:
COMPLETED
Last Update Posted:
2025-01-20
First Post:
2022-08-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety and Tolerability Study of QLS-101 in Adolescents With Sturge-Weber Syndrome (SWS)-Related Glaucoma Due to Elevated Episcleral Venous Pressure (EVP)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013341', 'term': 'Sturge-Weber Syndrome'}, {'id': 'D005901', 'term': 'Glaucoma'}, {'id': 'D009798', 'term': 'Ocular Hypertension'}], 'ancestors': [{'id': 'D006391', 'term': 'Hemangioma'}, {'id': 'D009383', 'term': 'Neoplasms, Vascular Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D020752', 'term': 'Neurocutaneous Syndromes'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D000798', 'term': 'Angiomatosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Open-label, single treatment'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-11-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'dispFirstSubmitDate': '2023-03-21', 'completionDateStruct': {'date': '2023-03-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-16', 'studyFirstSubmitDate': '2022-08-02', 'studyFirstSubmitQcDate': '2022-08-08', 'dispFirstPostDateStruct': {'date': '2023-03-27', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2025-01-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ocular safety', 'timeFrame': 'Over 28 days', 'description': 'Incidence of ocular treatment emergent adverse events (TEAEs)'}, {'measure': 'Systemic safety', 'timeFrame': 'Over 28 days', 'description': 'Incidence of systemic TEAEs'}], 'secondaryOutcomes': [{'measure': 'Ocular hypotensive effectiveness', 'timeFrame': '28 days', 'description': 'Mean change in intraocular pressure (IOP) (mmHg and % change) from baseline following 28 days dosing with QLS-101'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sturge-Weber Syndrome', 'Glaucoma', 'Ocular Hypertension']}, 'descriptionModule': {'briefSummary': 'Open-label study of an investigational product (IP), QLS-101, with 28-day every morning (QAM) dosing to both eyes (OU) in adolescents with SWS who have clinical evidence of glaucoma and/or ocular hypertension (OHT) related to SWS elevated EVP in at least one eye.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '19 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Between 12 and 19 years of age at Screening.\n* Diagnosed with SWS\n* Elevated IOP\n* Willing to continue current dosing regimen of IOP-lowering medications\n* Able to provide informed consent and follow study instructions\n\nExclusion Criteria:\n\n* Expected to undergo IOP-lowering surgery\n* Incisional or laser surgery of any type 4 months prior to study\n* Ocular infection, inflammation, clinically significant blepharitis or conjunctivitis, history of herpes simplex keratitis in either eye\n* History of or active clinically significant ocular disease\n* Use of topical ocular corticosteroids in the 6 weeks prior to study\n* Patient cannot be applanated or tolerate IOP measurements\n* Patient is pregnant or lactating\n* Uncontrolled systemic disease that can interfere with study participation\n* Inability to self-dose or identify a caregiver for all study eye drop administration'}, 'identificationModule': {'nctId': 'NCT05495269', 'briefTitle': 'Safety and Tolerability Study of QLS-101 in Adolescents With Sturge-Weber Syndrome (SWS)-Related Glaucoma Due to Elevated Episcleral Venous Pressure (EVP)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Qlaris Bio, Inc.'}, 'officialTitle': 'Pilot, Open-label Study of Safety and Tolerability of QLS-101 in Adolescents With Sturge-Weber Syndrome (SWS)-Related Glaucoma Due to Elevated Episcleral Venous Pressure (EVP)', 'orgStudyIdInfo': {'id': 'QC-205'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'QLS-101, 2.0%', 'description': "Qlaris' investigational product, QLS-101, 2.0% concentration, ocular administration (eye drop), given once daily in the morning to both eyes", 'interventionNames': ['Drug: QLS-101 ophthalmic solution, 2.0 %']}], 'interventions': [{'name': 'QLS-101 ophthalmic solution, 2.0 %', 'type': 'DRUG', 'otherNames': ['QLS-101'], 'description': 'ophthalmic solution in a single use dropper vial', 'armGroupLabels': ['QLS-101, 2.0%']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke Eye Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}], 'overallOfficials': [{'name': 'Sharon Freedman, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke Eye Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Qlaris Bio, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}