Ignite Creation Date:
2025-12-25 @ 5:09 AM
Ignite Modification Date:
2025-12-26 @ 4:14 AM
Study NCT ID:
NCT05656027
Status:
COMPLETED
Last Update Posted:
2024-12-18
First Post:
2022-12-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Phase 3 Evaluation of the Safety and Efficacy of LNZ101 for the Treatment of Presbyopia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011305', 'term': 'Presbyopia'}, {'id': 'D012030', 'term': 'Refractive Errors'}, {'id': 'D009216', 'term': 'Myopia'}, {'id': 'D015877', 'term': 'Miosis'}, {'id': 'D005128', 'term': 'Eye Diseases'}], 'ancestors': [{'id': 'D011681', 'term': 'Pupil Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C084650', 'term': 'aceclidine'}, {'id': 'D000068438', 'term': 'Brimonidine Tartrate'}], 'ancestors': [{'id': 'D011810', 'term': 'Quinoxalines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A multi-center, double-masked, randomized, active-controlled, safety and efficacy study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 469}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-12-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'dispFirstSubmitDate': '2024-12-12', 'completionDateStruct': {'date': '2024-01-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-13', 'studyFirstSubmitDate': '2022-12-09', 'studyFirstSubmitQcDate': '2022-12-09', 'dispFirstPostDateStruct': {'date': '2024-01-31', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2024-12-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary Outcome', 'timeFrame': '3 hours post-treatment in the study eye', 'description': 'Efficacy Study of the percentage of subjects who achieve a 3-line or greater improvement from baseline in the study eye with no loss in BCDVA ≥ 5 letters (ETDRS chart at 4 m).'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pharmaceutical Solutions', 'Eye Drops', 'CLARITY', 'Presbyopia', 'Ophthalmic Solutions', 'Miotic'], 'conditions': ['Presbyopia', 'Refractive Error', 'Near Vision', 'Miosis', 'Eye Diseases']}, 'descriptionModule': {'briefSummary': 'Phase 3 study to evaluate the safety and effectiveness of LNZ101 for the treatment of Presbyopia.', 'detailedDescription': 'Phase 3 study to evaluate the safety and effectiveness of LNZ101 compared with LNZ100 and Brimonidine for the treatment of Presbyopia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '45 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Be able and willing to provide written informed consent and sign a Health Information Portability and Accountability Act (HIPAA) form prior to any study procedure being performed;\n2. Be able and willing to follow all instructions and attend all study visits;\n3. Be 45-75 years of age of either sex and any race or ethnicity at Visit 1;\n4. Have +1.00 to -4.00 diopter (D) of sphere calculated in minus cylinder (so that spherical equivalent (SE) results in myopia no more severe than -4.00 D MRSE) in both eyes determined by manifest refraction documented at Visit 1;\n5. Have ≤2.00 D of cylinder (minus cylinder) in both eyes determined by manifest refraction documented at Visit 1;\n6. Be presbyopic as determined at Visit 1\n\nExclusion Criteria:\n\nSubjects must not:\n\n1. Be a female of childbearing potential who is currently pregnant, nursing, or planning a pregnancy;\n2. Have known contraindications or sensitivity to the use of any of the study medications or their components;\n3. Have an active ocular infection at Visit 1 or at Visit 2 (bacterial, viral, or fungal), positive history of an ocular herpetic infection, preauricular lymphadenopathy, or ongoing, active ocular inflammation in either eye;\n4. Have moderate or severe dry eye defined as total central corneal fluorescein staining in either eye at Visit 1;\n5. Have clinically significant abnormal lens findings including early lens changes in either eye during dilated slit-lamp biomicroscopy and fundus exam documented within 3 months of Visit 1 or at Visit 1;'}, 'identificationModule': {'nctId': 'NCT05656027', 'acronym': 'CLARITY', 'briefTitle': 'Phase 3 Evaluation of the Safety and Efficacy of LNZ101 for the Treatment of Presbyopia', 'organization': {'class': 'OTHER', 'fullName': 'LENZ Therapeutics, Inc'}, 'officialTitle': 'A Multi-Center, Double-Masked Phase 3 Evaluation of the Safety and Efficacy of LNZ101 for the Treatment of Presbyopia', 'orgStudyIdInfo': {'id': '22-150-0015'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Aceclidine + Brimonidine (LNZ101) dosed bilaterally', 'description': 'LNZ101 (Aceclidine /Brimonidine) ophthalmic solution', 'interventionNames': ['Drug: Aceclidine + Brimonidine']}, {'type': 'EXPERIMENTAL', 'label': 'Aceclidine Ophthalmic Solution (LNZ100) dosed bilaterally', 'description': 'LNZ100 (Aceclidine) ophthalmic solution', 'interventionNames': ['Drug: Aceclidine']}, {'type': 'EXPERIMENTAL', 'label': 'Brimonidine ophthalmic solution dosed bilaterally', 'description': 'Brimonidine ophthalmic solution', 'interventionNames': ['Drug: Brimonidine']}], 'interventions': [{'name': 'Aceclidine + Brimonidine', 'type': 'DRUG', 'description': 'LNZ101 (Aceclidine/Brimonidine) ophthalmic solution', 'armGroupLabels': ['Aceclidine + Brimonidine (LNZ101) dosed bilaterally']}, {'name': 'Aceclidine', 'type': 'DRUG', 'description': 'LNZ100 Aceclidine ophthalmic solution', 'armGroupLabels': ['Aceclidine Ophthalmic Solution (LNZ100) dosed bilaterally']}, {'name': 'Brimonidine', 'type': 'DRUG', 'description': 'Brimonidine ophthalmic solution', 'armGroupLabels': ['Brimonidine ophthalmic solution dosed bilaterally']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85224', 'city': 'Chandler', 'state': 'Arizona', 'country': 'United States', 'facility': 'Site #106', 'geoPoint': {'lat': 33.30616, 'lon': -111.84125}}, {'zip': '85202', 'city': 'Mesa', 'state': 'Arizona', 'country': 'United States', 'facility': 'Site #121', 'geoPoint': {'lat': 33.42227, 'lon': -111.82264}}, {'zip': '85032', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Site #122', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85053', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Site #124', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85351', 'city': 'Sun City', 'state': 'Arizona', 'country': 'United States', 'facility': 'Site #125', 'geoPoint': {'lat': 33.59754, 'lon': -112.27182}}, {'zip': '92843', 'city': 'Garden Grove', 'state': 'California', 'country': 'United States', 'facility': 'Site #110', 'geoPoint': {'lat': 33.77391, 'lon': -117.94145}}, {'zip': '91204', 'city': 'Glendale', 'state': 'California', 'country': 'United States', 'facility': 'Site #101', 'geoPoint': {'lat': 34.14251, 'lon': -118.25508}}, {'zip': '94954', 'city': 'Petaluma', 'state': 'California', 'country': 'United States', 'facility': 'Site #107', 'geoPoint': {'lat': 38.23242, 'lon': -122.63665}}, {'zip': '95670', 'city': 'Rancho Cordova', 'state': 'California', 'country': 'United States', 'facility': 'Site #126', 'geoPoint': {'lat': 38.58907, 'lon': -121.30273}}, {'zip': '93105', 'city': 'Santa Barbara', 'state': 'California', 'country': 'United States', 'facility': 'Site #111', 'geoPoint': {'lat': 34.42083, 'lon': -119.69819}}, {'zip': '80120', 'city': 'Littleton', 'state': 'Colorado', 'country': 'United States', 'facility': 'Site #109', 'geoPoint': {'lat': 39.61332, 'lon': -105.01665}}, {'zip': '32757', 'city': 'Mt. Dora', 'state': 'Florida', 'country': 'United States', 'facility': 'Site #102', 'geoPoint': {'lat': 28.80249, 'lon': -81.64452}}, {'zip': '61201', 'city': 'Rock Island', 'state': 'Illinois', 'country': 'United States', 'facility': 'Site #118', 'geoPoint': {'lat': 41.50948, 'lon': -90.57875}}, {'zip': '66762', 'city': 'Pittsburg', 'state': 'Kansas', 'country': 'United States', 'facility': 'Site #108', 'geoPoint': {'lat': 37.41088, 'lon': -94.70496}}, {'zip': '58103', 'city': 'Fargo', 'state': 'North Dakota', 'country': 'United States', 'facility': 'Site #104', 'geoPoint': {'lat': 46.87719, 'lon': -96.7898}}, {'zip': '18704', 'city': 'Kingston', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Site #103', 'geoPoint': {'lat': 41.26175, 'lon': -75.89686}}, {'zip': '38104', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Site #116', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'zip': '37167', 'city': 'Smyrna', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Site #112', 'geoPoint': {'lat': 35.98284, 'lon': -86.5186}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Site #119', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Site #123', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}], 'overallOfficials': [{'name': 'Alisyn Facemire, BA', 'role': 'STUDY_DIRECTOR', 'affiliation': 'LENZ Therapeutics'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'LENZ Therapeutics, Inc', 'class': 'OTHER'}, 'collaborators': [{'name': 'ORA, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}