Ignite Creation Date:
2025-12-25 @ 4:25 AM
Ignite Modification Date:
2025-12-26 @ 3:28 AM
Study NCT ID:
NCT06209320
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-07-30
First Post:
2024-01-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of the Efficacy and Safety of Two Low-concentration Atropine Sulfate Eye Drops
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': 'D001285', 'term': 'Atropine'}], 'ancestors': [{'id': 'D001286', 'term': 'Atropine Derivatives'}, {'id': 'D014326', 'term': 'Tropanes'}, {'id': 'D053961', 'term': 'Azabicyclo Compounds'}, {'id': 'D001372', 'term': 'Aza Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001533', 'term': 'Belladonna Alkaloids'}, {'id': 'D012991', 'term': 'Solanaceous Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D019086', 'term': 'Bridged Bicyclo Compounds, Heterocyclic'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 777}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-03-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-25', 'studyFirstSubmitDate': '2024-01-06', 'studyFirstSubmitQcDate': '2024-01-06', 'lastUpdatePostDateStruct': {'date': '2025-07-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Relationship between age and slow myopia progression', 'timeFrame': '24 months', 'description': 'Relationship between age and slow in myopia progression (SER change from baseline)'}], 'primaryOutcomes': [{'measure': 'Cycloplegic Autorefraction(SER)', 'timeFrame': '24 months', 'description': 'Between-group difference in the mean change from baseline in SER at visit M24'}], 'secondaryOutcomes': [{'measure': 'Axial Length', 'timeFrame': '24 months', 'description': 'Between-group difference in the mean change from baseline in axial length at visit M24'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Myopia']}, 'descriptionModule': {'briefSummary': 'A randomized, double-blind, placebo-controlled, multicenter, phase III clinical study of the efficacy and safety of two low-concentration atropine sulfate eye drops in slowing the progression of myopia in children', 'detailedDescription': 'Primary objective is to evaluate the efficacy and safety of atropine sulfate eye drops versus placebo for 12 months in slowing the progression of myopia in children.\n\nThe study was designed to enroll approximately 777 subjects. Eligible subjects were randomly assigned to the placebo control group, Lower dose atropine group and Lower dose atropine group. Subjects received the study medication in both eyes, 1 drop each time, once every night at bedtime.\n\nStatistical analyses were performed with the use of SAS software, version 9.4, without any specific description. All statistical tests were two-sided at a 0.05 level.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Child (female or male) aged 6 to 12 years.\n2. Myopia (SER of at least -0.50 D and no more myopic than -6.00 D) in each eye as measuredby cycloplegic autorefraction.\n3. If present, astigmatism of ≤1.50 D in each eye as measured by cycloplegic autorefraction.\n4. Anisometropia SER of \\< 1.50 D as measured by cycloplegic autorefraction.\n\nExclusion Criteria:\n\n1. Have used other myopia control methods other than those used in this study, such as instruments (orthokeratology lenses, multifocal glasses, progressive glasses), drugs (atropine, etc.); Only single vision glasses are allowed for myopia correction;\n2. Have used myopic control methods such as traditional Chinese medicine, auricular acupuncture, massage, and reverse beat within 30 days before screening;\n3. Use of any local or systemic antimuscarinic/anticholinergic medication (e.g., atropine, scopolamine, tropicamide, phenamine, diphenhydramine, oxytropine, tricyclic antidepressant, etc.) within 21 days before screening; Allowing for tests such as cycloplegic optometry;'}, 'identificationModule': {'nctId': 'NCT06209320', 'acronym': 'China-CHAMP', 'briefTitle': 'A Study of the Efficacy and Safety of Two Low-concentration Atropine Sulfate Eye Drops', 'organization': {'class': 'INDUSTRY', 'fullName': 'Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.'}, 'officialTitle': 'A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase III Clinical Study of the Efficacy and Safety of Two Low-concentration Atropine Sulfate Eye Drops in Slowing the Progression of Myopia in Children', 'orgStudyIdInfo': {'id': 'ZKO-ATP-202105-China-CHAMP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Experimental group 1', 'description': 'Lower dose atropine sulfate eye drops', 'interventionNames': ['Drug: Lower dose atropine sulfate eye drops']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Experimental group 2', 'description': 'Low dose atropine sulfate eye drops', 'interventionNames': ['Drug: Low dose atropine sulfate eye drops']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'control group', 'description': 'placebo', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'Lower dose atropine sulfate eye drops', 'type': 'DRUG', 'otherNames': ['Lower dose atropine sulfate'], 'description': 'administer to eyes', 'armGroupLabels': ['Experimental group 1']}, {'name': 'Low dose atropine sulfate eye drops', 'type': 'DRUG', 'otherNames': ['Low dose atropine sulfate'], 'description': 'administer to eyes', 'armGroupLabels': ['Experimental group 2']}, {'name': 'placebo', 'type': 'DRUG', 'otherNames': ['Vehicle'], 'description': 'administer to eyes', 'armGroupLabels': ['control group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Beijing Tongren Hospital, Capital Medical University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'Ningli Wang', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Beijing Tongren Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}