Ignite Creation Date:
2025-12-24 @ 10:22 PM
Ignite Modification Date:
2026-01-01 @ 5:33 PM
Study NCT ID:
NCT04947735
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-12-20
First Post:
2021-06-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CYPRESS Efficacy and Safety Study Extension
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009216', 'term': 'Myopia'}], 'ancestors': [{'id': 'D012030', 'term': 'Refractive Errors'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-07-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2026-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-18', 'studyFirstSubmitDate': '2021-06-18', 'studyFirstSubmitQcDate': '2021-06-24', 'lastUpdatePostDateStruct': {'date': '2024-12-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Axial length', 'timeFrame': '72 months', 'description': 'Test vs. control axial length change from baseline'}, {'measure': 'Spherical equivalent refraction (SER)', 'timeFrame': '72 months', 'description': 'Test vs. control spherical equivalent refraction (SER) change from baseline'}], 'secondaryOutcomes': [{'measure': 'Axial length', 'timeFrame': '42 months', 'description': 'Change from baseline'}, {'measure': 'SER', 'timeFrame': '60 months', 'description': 'Change from baseline'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Juvenile Myopia', 'Myopia']}, 'descriptionModule': {'briefSummary': 'This is an open-label, controlled, multisite, two-arm parallel group clinical trial of 36-month duration to evaluate the continued safety and efficacy of SightGlass Vision Diffusion Optics Technology (DOT) Spectacles in reducing the progression of juvenile myopia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '6 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Previously a successfully completed participant in the CYPRESS study (NCT03623074) and having not exited this study for more than 30 days;\n* Agree to wear the assigned spectacles constantly except for sleeping, swimming, or other activities in which spectacle wear would be dangerous or otherwise not possible (minimum of 10 hours per day);\n* Willingness to participate in the trial for up to 3 years without contact lens wear;\n* The subject's parent(s) or legal guardian(s) must read, understand and sign the Statement of Informed Consent and receive a fully executed copy of the form.\n\nExclusion Criteria:\n\n* Known allergy to proparacaine, tetracaine, or tropicamide."}, 'identificationModule': {'nctId': 'NCT04947735', 'acronym': 'CYPRESS', 'briefTitle': 'CYPRESS Efficacy and Safety Study Extension', 'organization': {'class': 'INDUSTRY', 'fullName': 'SightGlass Vision, Inc.'}, 'officialTitle': 'Control of Myopia Using Peripheral Diffusion Lenses: Efficacy and Safety Study Extension', 'orgStudyIdInfo': {'id': 'CPRO-1802-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CYPRESS Extension Test Arm', 'description': 'Single vision, impact resistant spectacle lenses; CYPRESS Test Arm 1 and CYPRESS Test Arm 2 will move into CYPRESS Extension Test Arm', 'interventionNames': ['Device: Novel spectacle lens design']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'CYPRESS Extension Control Arm', 'description': 'Single vision, impact resistant spectacle lenses; CYPRESS Control Arm remains in control lenses as the CYPRESS Extension Control Arm', 'interventionNames': ['Device: Spectacle lenses']}], 'interventions': [{'name': 'Novel spectacle lens design', 'type': 'DEVICE', 'description': 'Use of single vision, impact resistant spectacle lenses may reduce the rate of progression of juvenile myopia', 'armGroupLabels': ['CYPRESS Extension Test Arm']}, {'name': 'Spectacle lenses', 'type': 'DEVICE', 'description': 'Single vision, impact resistant spectacle lenses', 'armGroupLabels': ['CYPRESS Extension Control Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90606', 'city': 'Whittier', 'state': 'California', 'country': 'United States', 'facility': 'Golden Optometric Group', 'geoPoint': {'lat': 33.97918, 'lon': -118.03284}}, {'zip': '32779', 'city': 'Longwood', 'state': 'Florida', 'country': 'United States', 'facility': 'Omega Vision Center, PA', 'geoPoint': {'lat': 28.70305, 'lon': -81.3384}}, {'zip': '66762', 'city': 'Pittsburg', 'state': 'Kansas', 'country': 'United States', 'facility': 'Kannarr Eye Care', 'geoPoint': {'lat': 37.41088, 'lon': -94.70496}}, {'zip': '71291', 'city': 'West Monroe', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Haik Humble', 'geoPoint': {'lat': 32.51848, 'lon': -92.14764}}, {'zip': '64133', 'city': 'Raytown', 'state': 'Missouri', 'country': 'United States', 'facility': 'Advanced Eyecare PC', 'geoPoint': {'lat': 39.00862, 'lon': -94.46356}}, {'zip': '10036', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'SUNY School of Optometry', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '13850', 'city': 'Vestal', 'state': 'New York', 'country': 'United States', 'facility': 'Sacco Eye Group', 'geoPoint': {'lat': 42.08507, 'lon': -76.05381}}, {'zip': '57049', 'city': 'Dakota Dunes', 'state': 'South Dakota', 'country': 'United States', 'facility': 'Dunes Eye Consultants', 'geoPoint': {'lat': 42.48749, 'lon': -96.48642}}, {'zip': '38119', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Total Eye Care', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'zip': '77205', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Dr. Bridgitte Shen Lee (PI)', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '84106', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'William J Bogus, OD, FAAO', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': 'N2L 3G1', 'city': 'Waterloo', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Centre for Ocular Research and Education', 'geoPoint': {'lat': 43.4668, 'lon': -80.51639}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'SightGlass Vision, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}