Ignite Creation Date:
2025-12-25 @ 5:19 AM
Ignite Modification Date:
2025-12-26 @ 4:27 AM
Study NCT ID:
NCT06034327
Status:
RECRUITING
Last Update Posted:
2024-12-20
First Post:
2023-09-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy in Controlling Myopia in Young Children Using a Novel Spectacle Lens
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': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Participants and parents of participants will be masked. Investigational site staff tasked with measuring key primary variables will be masked.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-09-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2026-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-18', 'studyFirstSubmitDate': '2023-09-05', 'studyFirstSubmitQcDate': '2023-09-05', 'lastUpdatePostDateStruct': {'date': '2024-12-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Spherical equivalent refraction', 'timeFrame': '12 months', 'description': 'Change in spherical equivalent refraction from baseline'}], 'secondaryOutcomes': [{'measure': 'Axial length', 'timeFrame': '12 months', 'description': 'Change in axial length from baseline'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Myopia', 'Juvenile Myopia', 'Myopia Progression']}, 'descriptionModule': {'briefSummary': 'This is a conventional efficacy trial to validate the results from previous clinical trials for younger children; the 12-month efficacy results will be used to predict the 3-year treatment efficacy.\n\nThis is a randomized, controlled (1:1), multisite, subject- and observer-masked, 2-arm parallel group study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '8 Years', 'minimumAge': '6 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Children 6 - 8 years of age (inclusive) at time of informed consent/assent;\n2. Spherical equivalent refractive error between -0.75 and -4.50 D inclusive (by manifest refraction) in each eye;\n3. Astigmatism if present, less than or equal to -1.25 DC (by manifest refraction) in each eye;\n4. Best corrected visual acuity by manifest refraction of +0.10 logMAR (20/25 Snellen equivalent) or better in each eye;\n5. The difference in spherical equivalent power between the two eyes (anisometropia based on manifest refraction) must be less than or equal to 1.50 D;\n6. 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);\n7. Ability to comply with study procedures, including high and low contrast visual acuity, axial length, and cycloplegic autorefraction measurements taken for both eyes at the baseline visit;\n8. Willingness to participate in the trial for 24 months without contact lens wear;\n9. 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\n1. Subject has previously or currently wears contact lenses (greater than 1-month usage);\n2. Current or prior use of bifocals, progressive addition spectacle lenses\n3. Current or prior use of any myopia control treatment (e.g., atropine, multifocal contact lenses, orthokeratology);\n4. Amblyopia in either eye;\n5. Strabismus by cover test at far (4 m) or near (40 cm) wearing distance correction;\n6. Any ocular or systemic conditions that could influence refractive development or status \\[e.g., keratoconus, congenital glaucoma, ocular trauma, diabetes, Marfan syndrome or other connective tissue disorder, Down's syndrome, family history of poor night vision (to prevent against enrolling subjects with congenital stationary night blindness)\\];\n7. Known allergy to proparacaine, tetracaine, or tropicamide;\n8. Participation in any investigational clinical study within 30 days of the Baseline visit;\n9. Subject's sibling or other household member is already enrolled in this trial."}, 'identificationModule': {'nctId': 'NCT06034327', 'acronym': 'EUCALYPTUS', 'briefTitle': 'Efficacy in Controlling Myopia in Young Children Using a Novel Spectacle Lens', 'organization': {'class': 'INDUSTRY', 'fullName': 'SightGlass Vision, Inc.'}, 'officialTitle': 'Efficacy in Controlling Myopia in Young Children Using a Novel Spectacle Lens', 'orgStudyIdInfo': {'id': 'CPRO-2304-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Test Arm 1', 'description': 'Single vision, impact-resistant spectacle lenses', 'interventionNames': ['Device: Single vision, impact-resistant spectacle lenses; Test Arm']}, {'type': 'OTHER', 'label': 'Test Arm 2', 'description': 'Single vision, impact-resistant spectacle lenses', 'interventionNames': ['Device: Single vision, impact-resistant spectacle lenses; Control Arm']}], 'interventions': [{'name': 'Single vision, impact-resistant spectacle lenses; Test Arm', 'type': 'DEVICE', 'description': 'Use of single vision, impact-resistant spectacle lenses may reduce the rate of progression of juvenile myopia', 'armGroupLabels': ['Test Arm 1']}, {'name': 'Single vision, impact-resistant spectacle lenses; Control Arm', 'type': 'DEVICE', 'description': 'Single vision, impact-resistant spectacle lenses', 'armGroupLabels': ['Test Arm 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94607', 'city': 'Oakland', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Vanessa Chen', 'role': 'CONTACT', 'phone': '510-238-9797'}, {'name': 'Elsa Pao, OD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Elsa Pao, OD', 'geoPoint': {'lat': 37.80437, 'lon': -122.2708}}, {'zip': '92131', 'city': 'San Diego', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Leslie Shan, OD', 'role': 'CONTACT', 'phone': '858-530-2800'}, {'name': 'Keith Wan, OD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Scripps Poway Eyecare', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '94127', 'city': 'San Francisco', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Aileen Guzman', 'role': 'CONTACT', 'phone': '415-655-3937'}, {'name': 'Selena Chan, OD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Pacific Rims Optometry', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '92704', 'city': 'Santa Ana', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Daisy Magdaleno', 'role': 'CONTACT', 'phone': '714-557-9492'}, {'name': 'Vanessa Grichine, OD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Paje Optometric', 'geoPoint': {'lat': 33.74557, 'lon': -117.86783}}, {'zip': '32779', 'city': 'Longwood', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Renee Warren', 'role': 'CONTACT', 'phone': '407-869-4733'}, {'name': 'Christopher Pearson, OD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Omega Vision Center', 'geoPoint': {'lat': 28.70305, 'lon': -81.3384}}, {'zip': '30060', 'city': 'Marietta', 'state': 'Georgia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Doreatha Kennerly', 'role': 'CONTACT', 'phone': '678-803-2600', 'phoneExt': '2522'}, {'name': 'Monica Bratton, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Marietta Eye Clinic', 'geoPoint': {'lat': 33.9526, 'lon': -84.54993}}, {'zip': '60616', 'city': 'Chicago', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jessica Martinez', 'role': 'CONTACT', 'phone': '312-949-7000'}, {'name': 'Yi Pang, OD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ilinois College of Optometry', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '66762', 'city': 'Pittsburg', 'state': 'Kansas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Megan Compton, RN', 'role': 'CONTACT', 'phone': '620-235-1737'}, {'name': 'Shane Kannarr, OD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Kannarr Eye Care', 'geoPoint': {'lat': 37.41088, 'lon': -94.70496}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Lilly Cheam', 'role': 'CONTACT', 'phone': '617-266-2030'}, {'name': 'Katherine Green, OD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'New England College of Optometry', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '64133', 'city': 'Raytown', 'state': 'Missouri', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Tamara Urias', 'role': 'CONTACT', 'phone': '816-353-1872'}, {'name': 'Richard Wilson, OD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Advanced Eyecare PC', 'geoPoint': {'lat': 39.00862, 'lon': -94.46356}}, {'zip': '45701', 'city': 'Athens', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jen Brite', 'role': 'CONTACT', 'phone': '740-594-2271'}, {'name': 'Shane Foster, OD', 'role': 'CONTACT'}, {'name': 'Shane Foster, OD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Athens Eye Care', 'geoPoint': {'lat': 39.32924, 'lon': -82.10126}}, {'zip': '43023', 'city': 'Granville', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Katherine Bickle, OD', 'role': 'CONTACT'}, {'name': 'Katherine Bickle, OD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Procare Vision Centers, Inc.', 'geoPoint': {'lat': 40.06812, 'lon': -82.5196}}, {'zip': '77706', 'city': 'Beaumont', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Bobbie Hampton', 'role': 'CONTACT', 'phone': '409-899-9999'}, {'name': 'Samir Patel, OD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Texas State Optical - Dowlen', 'geoPoint': {'lat': 30.08605, 'lon': -94.10185}}, {'zip': '77401', 'city': 'Bellaire', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Ashley Tucker, OD', 'role': 'CONTACT'}, {'name': 'Ashley Tucker, OD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Bellaire Family Eye Care', 'geoPoint': {'lat': 29.70579, 'lon': -95.45883}}], 'centralContacts': [{'name': 'Jennifer S Hill, BS', 'role': 'CONTACT', 'email': 'jhill@sightglassvision.com', 'phone': '678-361-4877'}, {'name': 'Vanessa Tasso, MA, MBA', 'role': 'CONTACT', 'email': 'vtasso@sightglassvision.com', 'phone': '949-751-7039'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'SightGlass Vision, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}