Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2026-01-07 @ 9:30 AM
Study NCT ID:
NCT06528860
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-30
First Post:
2024-07-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dual-focus Soft Contact Lenses for Controlling Rapid Progressive Myopia in Young Adults
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003263', 'term': 'Contact Lenses, Hydrophilic'}], 'ancestors': [{'id': 'D003261', 'term': 'Contact Lenses'}, {'id': 'D007909', 'term': 'Lenses'}, {'id': 'D055096', 'term': 'Optical Devices'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR'], 'maskingDescription': 'This study will utilize a Central Randomization System (CRS) for the random grouping and glasses allocation of study subjects during the clinical trial. Investigators and participants will be blinded to the intervention received until unblinding.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Intervention Group: Daily disposable bifocal soft corneal contact lenses: MiSight® 1 day soft contact lens (CooperVision, material: omafilcon A, water content: 60%).\n\nControl Group: Daily disposable single-focus soft corneal contact lenses: Proclear® 1 day soft contact lens (CooperVision, material: omafilcon A, water content: 60%)'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 144}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-08-31', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2027-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-26', 'studyFirstSubmitDate': '2024-07-26', 'studyFirstSubmitQcDate': '2024-07-26', 'lastUpdatePostDateStruct': {'date': '2024-07-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in cycloplegic spherical equivalent after 2 years', 'timeFrame': '2 years after the baseline', 'description': 'The difference in the change of cycloplegic spherical equivalent between the intervention group and the control group.'}], 'secondaryOutcomes': [{'measure': 'Change in axial length after 2 years', 'timeFrame': '2 years after the baseline', 'description': 'The difference in the change of axial length between the intervention group and the control group.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Myopia', 'Dual-focus contact lenses', 'Young adults', 'Adult myopia progression'], 'conditions': ['Myopia']}, 'referencesModule': {'references': [{'pmid': '32915454', 'type': 'BACKGROUND', 'citation': 'Ruiz-Pomeda A, Villa-Collar C. Slowing the Progression of Myopia in Children with the MiSight Contact Lens: A Narrative Review of the Evidence. Ophthalmol Ther. 2020 Dec;9(4):783-795. doi: 10.1007/s40123-020-00298-y. Epub 2020 Sep 11.'}, {'pmid': '37126362', 'type': 'BACKGROUND', 'citation': 'Bullimore MA, Lee SS, Schmid KL, Rozema JJ, Leveziel N, Mallen EAH, Jacobsen N, Iribarren R, Verkicharla PK, Polling JR, Chamberlain P. IMI-Onset and Progression of Myopia in Young Adults. Invest Ophthalmol Vis Sci. 2023 May 1;64(6):2. doi: 10.1167/iovs.64.6.2.'}]}, 'descriptionModule': {'briefSummary': 'This study aims to evaluate the effectiveness and acceptability of dual-focus soft contact lenses in controlling rapid myopia progression in adults through a randomized controlled trial. By applying myopia control measures to the adult population, we hope to provide scientific evidence for the effective control of adult myopia progression and offer insights into the understanding of myopia progression during early adulthood.', 'detailedDescription': 'It has long been believed that the progression of myopia mainly occurs during the elementary to high school stages. However, some studies and clinical practice suggest that a considerable proportion of adults still experience myopia progression in their adulthood, especially in those who have prolonged near work or screen usage time. At present, there is insufficient evidence on whether these population needs myopia control intervention. Most adults experiencing myopia progression do not receive appropriate myopic intervention measures, leading to an increase of dioptre, which may affect the quality of daily life, and raise the risk of high myopia and blinding myopia complications.\n\nThis study aims to evaluate the effectiveness and acceptability of dual-focus soft contact lenses in controlling rapid myopia progression in adults through a randomized controlled trial. By applying myopia control measures to the adult population, we hope to provide scientific evidence for the effective control of adult myopia progression and offer insights into the understanding of myopia progression during early adulthood.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '25 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age 18-25 years;\n* Myopia progression \\<= -0.50D in either eye in the past year (evaluated by -manifest refraction);\n* The subject eye: cycloplegic spherical equivalent ranges from -2.00D to -6.0D and cylinder power doesn't exceed -1.50D;\n* The subject eye's best corrected visual acuity \\<= logMAR 0.1;\n* Anisometropia does not exceed 1.50D.\n\nExclusion Criteria:\n\n* Current use of MC interventions or prior use of MC interventions within the past 6 months;\n* Disease or anatomical factors that affect the wearing of contact lenses;\n* History of myopia correction surgery;\n* Suffering from ocular or systemic diseases that may be related to myopia, such as Marfan syndrome, retinopathy of prematurity, diabetes, etc.;\n* pregnant female;\n* Other conditions deemed unsuitable by the investigators."}, 'identificationModule': {'nctId': 'NCT06528860', 'briefTitle': 'Dual-focus Soft Contact Lenses for Controlling Rapid Progressive Myopia in Young Adults', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Eye Disease Prevention and Treatment Center'}, 'officialTitle': 'The Effectiveness and Acceptability of Dual-focus Soft Contact Lenses for Controlling Rapid Progressive Myopia in Young Adults: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'QX-2024-A-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dual-focus CL', 'description': 'Wearing dual-focus CL for 2 years', 'interventionNames': ['Device: MiSight® 1 day soft contact lenses']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Single-vision CL', 'description': 'Wearing single-vision CL for 2 years', 'interventionNames': ['Device: Proclear® 1 day soft contact lenses']}], 'interventions': [{'name': 'MiSight® 1 day soft contact lenses', 'type': 'DEVICE', 'otherNames': ['CooperVision'], 'description': 'Dual-focus contact lenses, daily disposable, material: omafilcon A, water content: 60%.', 'armGroupLabels': ['Dual-focus CL']}, {'name': 'Proclear® 1 day soft contact lenses', 'type': 'DEVICE', 'otherNames': ['CooperVision'], 'description': 'Single-vision contact lenses, daily disposable, material: omafilcon A, water content: 60%.', 'armGroupLabels': ['Single-vision CL']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200041', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'contacts': [{'name': 'Xiangui He', 'role': 'CONTACT', 'email': 'xianhezi@163.com', 'phone': '(86)15000755422'}, {'name': 'Hotin Wu', 'role': 'CONTACT', 'email': '24499980@sjtu.edu.cn', 'phone': '(86)19821287621'}], 'facility': 'Shanghai Eye Disease Prevention & Treatment Center', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Xiangui He', 'role': 'CONTACT', 'email': 'xianhezi@163.com', 'phone': '(86)15000755422'}, {'name': 'Hotin Wu', 'role': 'CONTACT', 'email': '24499980@sjtu.edu.cn', 'phone': '(86)19821287621'}], 'overallOfficials': [{'name': 'Xiangui He', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shanghai Eye Disease Prevention & Treatment Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Eye Disease Prevention and Treatment Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}