Ignite Creation Date:
2025-12-25 @ 5:06 AM
Ignite Modification Date:
2025-12-26 @ 4:10 AM
Study NCT ID:
NCT04857827
Status:
COMPLETED
Last Update Posted:
2025-01-20
First Post:
2021-04-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Evaluate Safety and Tolerability of QLS-101 in NTG
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D057066', 'term': 'Low Tension Glaucoma'}, {'id': 'D005901', 'term': 'Glaucoma'}], 'ancestors': [{'id': 'D009798', 'term': 'Ocular Hypertension'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D009901', 'term': 'Optic Nerve Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009883', 'term': 'Ophthalmic Solutions'}, {'id': 'D013999', 'term': 'Timolol'}], 'ancestors': [{'id': 'D019999', 'term': 'Pharmaceutical Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D020313', 'term': 'Specialty Uses of Chemicals'}, {'id': 'D011412', 'term': 'Propanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D020005', 'term': 'Propanols'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D013830', 'term': 'Thiadiazoles'}, {'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D009025', 'term': 'Morpholines'}, {'id': 'D010078', 'term': 'Oxazines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'Study subjects, Investigators and their staff, and Sponsor personnel involved with the conduct and monitoring of the study will be masked to the investigational product (IP) identity until after the final database is locked. IPs will be provided in identical-appearing pouches to maintain masking.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-09-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'dispFirstSubmitDate': '2023-03-21', 'completionDateStruct': {'date': '2022-08-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-16', 'studyFirstSubmitDate': '2021-04-20', 'studyFirstSubmitQcDate': '2021-04-22', 'dispFirstPostDateStruct': {'date': '2023-03-27', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2025-01-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ocular safety', 'timeFrame': '86 days', 'description': 'Number of participants with treatment-related adverse events will be monitored'}], 'secondaryOutcomes': [{'measure': 'Ocular hypotensive efficacy', 'timeFrame': '14 days', 'description': 'Number of participants with intraocular pressure reduction from baseline will be calculated'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['low tension glaucoma (LTG)', 'glaucoma'], 'conditions': ['Normal Tension Glaucoma (NTG)']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://qlaris.bio', 'label': 'company website'}]}, 'descriptionModule': {'briefSummary': 'A randomized active-controlled multi-site double-masked 28 day study to evaluate the safety and tolerability of QLS-101 versus timolol maleate Preservative Free (PF) 0.5% ophthalmic solution in subjects with normal tension glaucoma'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Visual acuity +1.0 logMAR or better\n2. Willing to give informed consent\n3. Ability to washout from current intraocular pressure lowering medications -\n\nExclusion Criteria:\n\n1. All secondary glaucomas\n2. Previous glaucoma intraocular or laser surgery (selective laser trabeculoplasty permitted when done 18 months or longer from Screening)\n3. Refractive surgery\n4. Ocular infection or inflammation'}, 'identificationModule': {'nctId': 'NCT04857827', 'briefTitle': 'A Study to Evaluate Safety and Tolerability of QLS-101 in NTG', 'organization': {'class': 'INDUSTRY', 'fullName': 'Qlaris Bio, Inc.'}, 'officialTitle': 'A Randomized Active-controlled Study to Evaluate Safety and Tolerability of QLS-101 Versus Timolol Preservative Free (PF) Ophthalmic Solution in Subjects With Normal Tension Glaucoma (NTG)', 'orgStudyIdInfo': {'id': 'QC-202'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'QLS-101 ophthalmic solution 1.0%', 'description': 'Ophthalmic solution once daily (QD) dosing in both eyes (OU) for 14 days followed by 14 days of twice daily (BID) dosing.', 'interventionNames': ['Drug: QLS-101']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Timolol maleate PF 0.5% ophthalmic solution', 'description': 'Ophthalmic solution QD OU dosing for 14 days followed by 14 days BID OU dosing.', 'interventionNames': ['Drug: Timolol maleate PF 0.5% ophthalmic solution']}, {'type': 'EXPERIMENTAL', 'label': 'QLS-101 ophthalmic solution 2.0%', 'description': 'Ophthalmic solution QD OU dosing for 14 days followed by 14 days BID OU dosing.', 'interventionNames': ['Drug: QLS-101']}], 'interventions': [{'name': 'QLS-101', 'type': 'DRUG', 'otherNames': ['QLS-101 ophthalmic solution'], 'description': 'Ophthalmic solution QD OU dosing for 14 days followed by 14 days BID OU dosing.', 'armGroupLabels': ['QLS-101 ophthalmic solution 1.0%', 'QLS-101 ophthalmic solution 2.0%']}, {'name': 'Timolol maleate PF 0.5% ophthalmic solution', 'type': 'DRUG', 'otherNames': ['Timolol'], 'description': 'Ophthalmic solution QD OU dosing for 14 days followed by 14 days BID OU dosing.', 'armGroupLabels': ['Timolol maleate PF 0.5% ophthalmic solution']}]}, 'contactsLocationsModule': {'locations': [{'zip': '57108', 'city': 'Sioux Falls', 'state': 'South Dakota', 'country': 'United States', 'facility': 'Vance Thompson Vision', 'geoPoint': {'lat': 43.54369, 'lon': -96.72796}}], 'overallOfficials': [{'name': 'B. Wirostko, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Qlaris Bio, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Qlaris Bio, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}