Ignite Creation Date:
2025-12-24 @ 9:07 PM
Ignite Modification Date:
2026-04-02 @ 1:30 AM
Study NCT ID:
NCT06553404
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-08-14
First Post:
2024-07-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Myoslow Lens Study to Control Myopia in Children
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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR'], 'maskingDescription': 'Participants and site staff will be masked to the assigned arm'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'RCT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 125}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-11-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2025-11-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-11', 'studyFirstSubmitDate': '2024-07-28', 'studyFirstSubmitQcDate': '2024-08-11', 'lastUpdatePostDateStruct': {'date': '2024-08-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'spherical equivalent error', 'timeFrame': '24 months', 'description': 'Change in spherical equivalent refractive error from baseline to 24-month visit'}], 'secondaryOutcomes': [{'measure': 'Axial length', 'timeFrame': '24 months', 'description': 'Mean change in axial length (mm) from baseline at 24-month visit (Based on Biometry)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Myopia']}, 'descriptionModule': {'briefSummary': 'A Prospective, randomized, controlled double masked trial to assess the performance of Myoslow lens in slowing myopia progression in children.\n\nThe following study measures will be assessed:\n\n* Demographics and medical history\n* Current spectacles\n* Best Corrected Visual Acuity (BCVA) assessed by Measurement and Summation (M\\&S) system\n* Biometry\n* Cover test\n* Stereopsis\n* Ocular Motility\n* Pupil responses\n* Cycloplegic refraction\n* Fundus Examination\n* Vision related quality of life using the questionnaire Pediatric Refractive Error Profile (PREP)2\n* Adverse Events'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children, 6-12 years old\n* Spherical Equivalence Refraction (SER): -1.00 to -5.00 Diopter (D).\n* Astigmatism and anisometropia of 1.50 D or less.\n* Best Corrected Visual Acuity (BCVA) (6 / 7.5) or higher.\n\nExclusion Criteria:\n\n* Eye and systemic disorders.\n* Previously treated for myopia'}, 'identificationModule': {'nctId': 'NCT06553404', 'briefTitle': 'Myoslow Lens Study to Control Myopia in Children', 'organization': {'class': 'INDUSTRY', 'fullName': 'Crystal Optic'}, 'officialTitle': 'A Prospective, Randomized, Controlled Double Masked Trial to Assess the Performance of Myoslow Lens in Slowing Myopia Progression in Children', 'orgStudyIdInfo': {'id': 'CLD-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Single vision', 'description': 'Single vision glasses', 'interventionNames': ['Device: Single Vision']}, {'type': 'EXPERIMENTAL', 'label': 'myoslow', 'description': 'The Myoslow spectacle lens is based on the Defocus Incorporated Multiple Segments (DIMS) mechanism of action. This lens provides the same optical image as the Defocusing Incorporated Soft Contact Lens (DISC) without the drawbacks inherent with contact lens fitting.', 'interventionNames': ['Device: Myoslow']}], 'interventions': [{'name': 'Myoslow', 'type': 'DEVICE', 'description': 'The Myoslow spectacle lens is based on the Defocus Incorporated Multiple Segments (DIMS) mechanism of action. This lens provides the same optical image as the Defocusing Incorporated Soft Contact Lens (DISC) without the drawbacks inherent with contact lens fitting.', 'armGroupLabels': ['myoslow']}, {'name': 'Single Vision', 'type': 'DEVICE', 'description': 'Single vision glasses', 'armGroupLabels': ['Single vision']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ramat Gan', 'country': 'Israel', 'facility': 'Sheba MC', 'geoPoint': {'lat': 32.08227, 'lon': 34.81065}}], 'overallOfficials': [{'name': 'Haim Stolovitch, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Crystal Optic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'coded data only'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Crystal Optic', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}