Ignite Creation Date:
2025-12-24 @ 6:28 PM
Ignite Modification Date:
2025-12-28 @ 10:17 AM
Study NCT ID:
NCT06850168
Status:
RECRUITING
Last Update Posted:
2025-08-07
First Post:
2025-02-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Investigation of a Novel Spectacle Lens on Slowing Down Juvenile Myopia Progression
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009216', 'term': 'Myopia'}, {'id': 'D012030', 'term': 'Refractive Errors'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This is a 2-year, randomized, double-masked, contralateral, exploratory clinical trial with the objective to evaluate the efficacy of two test lenses designed with passive red-light emission in the control of myopia progression. The subject starts by wearing standard SVL, designed with passive red-light emission in one eye, and standard SVL in the contralateral eye. After 1 year, the eye wearing SVL designed with passive red-light emission will be replaced with standard MCL, and the contralateral eye will be replaced with standard MCL designed with passive red-light emission. At the end of the 2-year period, each eye would be exposed to lenses designed with passive red-light emission for 1 year each. There will be a total of 11 study visits with follow-up periods at 6 months, 12 months, 18 months and 24 months.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 35}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-06-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-04', 'studyFirstSubmitDate': '2025-02-24', 'studyFirstSubmitQcDate': '2025-02-24', 'lastUpdatePostDateStruct': {'date': '2025-08-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Axial Length', 'timeFrame': 'From baseline to 12 months'}, {'measure': 'Change in Axial Length', 'timeFrame': 'From 12 months to 24 months'}], 'secondaryOutcomes': [{'measure': 'Change in Spherical Equivalent Refraction', 'timeFrame': 'From baseline to 12 months'}, {'measure': 'Change in Spherical Equivalent Refraction', 'timeFrame': 'From 12 months to 24 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Refractive error', 'Eye disease', 'Axial length', 'Myopia control'], 'conditions': ['Myopia']}, 'referencesModule': {'references': [{'pmid': '34863776', 'type': 'BACKGROUND', 'citation': 'Jiang Y, Zhu Z, Tan X, Kong X, Zhong H, Zhang J, Xiong R, Yuan Y, Zeng J, Morgan IG, He M. Effect of Repeated Low-Level Red-Light Therapy for Myopia Control in Children: A Multicenter Randomized Controlled Trial. Ophthalmology. 2022 May;129(5):509-519. doi: 10.1016/j.ophtha.2021.11.023. Epub 2021 Dec 1.'}, {'pmid': '36049646', 'type': 'BACKGROUND', 'citation': 'Dong J, Zhu Z, Xu H, He M. Myopia Control Effect of Repeated Low-Level Red-Light Therapy in Chinese Children: A Randomized, Double-Blind, Controlled Clinical Trial. Ophthalmology. 2023 Feb;130(2):198-204. doi: 10.1016/j.ophtha.2022.08.024. Epub 2022 Aug 29.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this exploratory clinical trial is to evaluate the efficacy and safety of a test spectacle lens (standard single vision lens (SVL) during first year, and standard myopia control lens (MCL) in second year), designed with passive red-light emission, for the control of myopia progression in myopic children age 6 to 11 years old, both male and female, with no systemic or ocular anomalies. The main question it aims to answer is:\n\nDoes the test spectacle lens designed with passive red-light emission provide significant myopia control effect to children?\n\nResearchers will compare the standard SVL designed with passive red-light emission to SVL (first year) and MCL designed with passive red-light emission to MCL (second year) to see if the test spectacle lens work to slow down myopia progression.\n\nParticipants will:\n\n* Wear the study spectacles\n* Visit Essilor R\\&D Centre for follow-up sessions'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '11 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Children equal to or greater than 6 years old and less than 11 years at the time of signing informed consent.\n* Corrected spherical equivalent refraction (SER) between -0.75 D and -5.00 D with astigmatism not more than 2.50 D.\n* Difference in SER (Anisometropia) between two eyes should not exceed 1.00 D.\n* Best corrected visual acuity better than or equal to +0.10 log MAR (20/25 or better with Snellen).\n* Be in good general health, based on his/her and parent's/guardian's knowledge.\n* Agree to wear spectacles for \\>12 hours/day and at least 6 days/week.\n* Willingness and ability to participate in investigation for 2 years and attend scheduled visits.\n\nExclusion Criteria:\n\n* Any ocular or systemic pathologies known to affect refractive status (e.g. keratoconus, diabetes, Down's syndrome etc.)\n* Any binocular vision anomalies\n* Amblyopia\n* Use of prior myopia control treatment like specialized myopia control spectacles and contact lenses at least in the previous one month.\n* Current use of ocular or systemic medications which, in the investigator's opinion, may significantly affect pupil size, accommodation or refractive state.\n* Participation in any clinical investigation within 30 days of the baseline visit."}, 'identificationModule': {'nctId': 'NCT06850168', 'briefTitle': 'Clinical Investigation of a Novel Spectacle Lens on Slowing Down Juvenile Myopia Progression', 'organization': {'class': 'INDUSTRY', 'fullName': 'Essilor International'}, 'officialTitle': 'Clinical Investigation of a Novel Spectacle Lens on Slowing Down Juvenile Myopia Progression', 'orgStudyIdInfo': {'id': 'WS10367'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A', 'description': '(Year 1) OD: SVL with passive red-light emission; OS: SVL (Year 2) OD: MCL; OS: MCL with passive red-light emission', 'interventionNames': ['Device: SVL', 'Device: SVL with passive red-light emission', 'Device: MCL', 'Device: MCL with passive red-light emission']}, {'type': 'EXPERIMENTAL', 'label': 'Group B', 'description': '(Year 1) OD: SVL; OS: SVL with passive red-light emission (Year 2) OD: MCL with passive red-light emission; OS: MCL', 'interventionNames': ['Device: SVL', 'Device: SVL with passive red-light emission', 'Device: MCL', 'Device: MCL with passive red-light emission']}], 'interventions': [{'name': 'SVL', 'type': 'DEVICE', 'description': 'Dispensed to one eye in Year 1', 'armGroupLabels': ['Group A', 'Group B']}, {'name': 'SVL with passive red-light emission', 'type': 'DEVICE', 'description': 'Dispensed to the contralateral eye in Year 1.', 'armGroupLabels': ['Group A', 'Group B']}, {'name': 'MCL', 'type': 'DEVICE', 'description': 'Dispensed to one eye in Year 2 (if used SVL with passive red-light emission in Year 1).', 'armGroupLabels': ['Group A', 'Group B']}, {'name': 'MCL with passive red-light emission', 'type': 'DEVICE', 'description': 'Dispensed to the contralateral eye in Year 2 (if used SVL in Year 1).', 'armGroupLabels': ['Group A', 'Group B']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Singapore', 'status': 'RECRUITING', 'country': 'Singapore', 'contacts': [{'name': 'Celine Carimalo', 'role': 'CONTACT', 'email': 'carimalc@essilor.com.sg', 'phone': '67134617'}], 'facility': 'Essilor R&D Centre Singapore', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}], 'centralContacts': [{'name': 'Celine Carimalo', 'role': 'CONTACT', 'email': 'carimalc@essilor.com.sg', 'phone': '+65 67134617'}, {'name': 'Thomas Boudenne', 'role': 'CONTACT', 'email': 'thomas.boudenne@essilor.com'}], 'overallOfficials': [{'name': 'Andrew Tan', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Essilor R&D Centre Singapore'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Essilor International', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}