Ignite Creation Date:
2025-12-24 @ 7:40 PM
Ignite Modification Date:
2026-03-01 @ 12:04 PM
Study NCT ID:
NCT06765603
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-01-09
First Post:
2025-01-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluating the Efficacy of the Combination of Multi-zonal Contact Lens and Atropine for Controlling Myopia Progression
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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'RCT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 180}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-02-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2029-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-03', 'studyFirstSubmitDate': '2025-01-03', 'studyFirstSubmitQcDate': '2025-01-03', 'lastUpdatePostDateStruct': {'date': '2025-01-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in spherical equivalent', 'timeFrame': '12 months', 'description': 'Change in spherical equivalent at 12 months'}], 'secondaryOutcomes': [{'measure': 'Change in axial length', 'timeFrame': '12 months', 'description': 'Change in axial length at 12 months'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['myopia intervention'], 'conditions': ['Myopia']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to explore efficacy of combination Atropine and multifocal CL. Randomized Control Trial including 4 arms: Atropine / multizonal CL; Atropine/ SV CL, Placebo drop/ multizonal CL; Placebo drop/ SV CL. Followed over 1 year with outcome measure of change in spherical equivalent and axial length.', 'detailedDescription': 'see above'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '13 Years', 'minimumAge': '7 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Between 7 and 12 (inclusive) years of age at the time of screening.\n* spherical equivalent of cycloplegic objective refraction (by autorefraction) range of -0.75 D to -4.50 D (inclusive) in each eye.\n* Refractive cylinder less than 1.12 D (inclusive)\n* Best-corrected visual acuity (BCVA) of 0.04 logMAR or better in each eye, with difference less than 0.20 logMAR between eyes.\n* Have normal eyes (i.e., no ocular medications or infections of any type).\n\nExclusion Criteria:\n\n* Past or current use of myopia control treatment or involvement in previous myopia control study\n* Any current or seasonal use of ocular medication (eg. for allergy or chronic blepharitis).\n* hypersensitivity or allergic reaction to atropine, cyclopentolate, topical anesthetics or study approved rewetting drop solutions available in local markets.\n* previous history or signs of a contact lens-related corneal inflammatory event (e.g., past ulcer or scar) that may contraindicate contact lens wear.\n* Any ocular allergies, infections or other ocular abnormalities that are known to interfere with contact lens wear and/or participation in the study. This may include, but not be limited to entropion, ectropion, extrusions, chalazia, recurrent styes, ocular hypertension, glaucoma, history of recurrent corneal erosions, aphakia, uveitis, severe keratoconjunctivitis sicca, keratoconus, keratoconus suspect, and pellucid marginal degeneration.\n* Grade 3 or greater palpebral conjunctival observations or any other Grade 2 or greater slit-lamp findings (eg. edema, corneal neovascularization, corneal staining, conjunctival injection) on the ISO 11980 classification scale.\n* Any central corneal scar or corneal distortion resulting from ocular diseases or previous hard or rigid permeable contact lens wear.'}, 'identificationModule': {'nctId': 'NCT06765603', 'briefTitle': 'Evaluating the Efficacy of the Combination of Multi-zonal Contact Lens and Atropine for Controlling Myopia Progression', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Singapore National Eye Centre'}, 'officialTitle': 'Evaluating the Efficacy of the Combination of Multi-zonal Contact Lens and Atropine for Controlling Myopia Progression', 'orgStudyIdInfo': {'id': 'R1867/109/2021'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Atropine - SVCL', 'description': 'Atropine 0.025%', 'interventionNames': ['Drug: Atropine 0.025%', 'Device: Single vision Contact lens']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Atropine- multizonal CL', 'description': 'Atropine 0.025% and multizonal CL', 'interventionNames': ['Drug: Atropine 0.025%', 'Device: Multizonal contact lens']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Multizonal CL - placebo drop', 'description': 'Multizonal CL', 'interventionNames': ['Device: Multizonal contact lens', 'Drug: Placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo drop and SVCL', 'description': 'Placebo', 'interventionNames': ['Drug: Placebo', 'Device: Single vision Contact lens']}], 'interventions': [{'name': 'Atropine 0.025%', 'type': 'DRUG', 'description': 'Atropine 0.025%', 'armGroupLabels': ['Atropine - SVCL', 'Atropine- multizonal CL']}, {'name': 'Multizonal contact lens', 'type': 'DEVICE', 'description': 'Multizonal CL', 'armGroupLabels': ['Atropine- multizonal CL', 'Multizonal CL - placebo drop']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo', 'armGroupLabels': ['Multizonal CL - placebo drop', 'Placebo drop and SVCL']}, {'name': 'Single vision Contact lens', 'type': 'DEVICE', 'description': 'Single vision contact lens', 'armGroupLabels': ['Atropine - SVCL', 'Placebo drop and SVCL']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'audrey chia, PhD', 'role': 'CONTACT', 'email': 'audrey.chia.w.l@singhealth.com.sg', 'phone': '65 62277255'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Singapore National Eye Centre', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'pi', 'investigatorFullName': 'Audrey Wei-Lin Chia', 'investigatorAffiliation': 'Singapore National Eye Centre'}}}}