Ignite Creation Date:
2025-12-24 @ 11:28 PM
Ignite Modification Date:
2026-01-02 @ 3:29 AM
Study NCT ID:
NCT05529056
Status:
UNKNOWN
Last Update Posted:
2023-02-23
First Post:
2022-08-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Atropine Therapeutic Effect on Myopic 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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 472}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-05-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-02-21', 'studyFirstSubmitDate': '2022-08-10', 'studyFirstSubmitQcDate': '2022-09-01', 'lastUpdatePostDateStruct': {'date': '2023-02-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Spherical Equivalent over 12-month', 'timeFrame': '12 months', 'description': 'Change in spherical equivalent measured by cycloplegic autorefraction at 12 months after administration of clinical trial drug compared to baseline'}], 'secondaryOutcomes': [{'measure': 'Change in Spherical Equivalent', 'timeFrame': '4, 8 months', 'description': 'Change in spherical equivalent measured by cycloplegic autorefraction at 4, 8 months after administration of clinical trial drug compared to baseline'}, {'measure': 'Change in Axial length (mm)', 'timeFrame': '4, 8, 12 months', 'description': 'Change in Axial length (mm) at 4, 8, 12 months after administration of clinical trial drug compared to baseline'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Myopia', 'Children']}, 'descriptionModule': {'briefSummary': 'This study is to evaluate the therapeutic effect and safety of LPTAT in children with myopia.', 'detailedDescription': 'The primary objective is to evaluate the superiority of LPTAT to placebo in slowing myopia progression through the change of SE(Spherical Equivalent), which is measured by cycloplegic autorefraction after 12-month treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Aged 5 to 12 years at the time of consent\n* Refractive error of SE at least -1.0 D and no greater than -8.0 D in both eyes as measured by cycloplegic autorefraction at visit 1 and visit 2.\n* Confirmed myopia progression of 0.5D or more within past 1year\n* Astigmatism of 2.5D or less in both eyes\n* Distance Best Corrective Visual Acuity to logMAR 0.2 or better in both eyes at visit1.\n* Normal IOP under 21mmHg in both eyes.\n* Anisometropia of SE less than 2.0D as measured by cycloplegic autorefraction at visit 1.\n* Written informed consent willingly obtained by both subject and his/her parents\n\nExclusion Criteria:\n\n* Hypersensitivity to atropine or other cycloplegic agent.\n* History of the surgery of refractive correction\n* Having ocular disease affect to visual function or refractive error: history of glaucoma, macula r degeneration, diabetic eye disease, uveitis, etc, or presence of conjunctivitis at screening visit.\n* Having systemic diseases that affect to vision loss\n* Having risk of IOP elevation such as narrow angle, Shallow Anterior Chambers, etc\n* Presence of binocular function disorder or stereopsis disorder\n* Amblyopia or manifest strabismus\n* History of premature birth(less than 37weeks) or low birth weight(less than 2,500g)\n* Previous or current use of atropine or Ortho-K lens for myopia\n* Down syndrome, spastic paralysis, brain damage, spastic palsy, bladder\n* Presence of neurological diseases like epilepsy, etc. which could expect difficulties in compliant to the ocular examinations.\n* Presence of clinically significant cardiac and respiratory diseases\n* Participation in any other clinical study of an investigational product within 3-month prior to current IP administration.\n* Based on the investigator's discretion, subject who is not proper to participate in the trial."}, 'identificationModule': {'nctId': 'NCT05529056', 'acronym': 'STAMP', 'briefTitle': 'Study of Atropine Therapeutic Effect on Myopic Progression', 'organization': {'class': 'INDUSTRY', 'fullName': 'LitePharmTech Co., Ltd.'}, 'officialTitle': 'A Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Therapeutic Effect and Safety of LPTAT in Children With Myopia', 'orgStudyIdInfo': {'id': 'LPT-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Test Arm 1', 'description': 'LPTAT01', 'interventionNames': ['Drug: Atropine Sulfate 01']}, {'type': 'EXPERIMENTAL', 'label': 'Test Arm 2', 'description': 'LPTAT02', 'interventionNames': ['Drug: Atropine Sulfate 02']}, {'type': 'EXPERIMENTAL', 'label': 'Test Arm 3', 'description': 'LPTAT03', 'interventionNames': ['Drug: Atropine Sulfate 03']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Reference Arm', 'description': 'LPTAT04', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Atropine Sulfate 01', 'type': 'DRUG', 'otherNames': ['LPTAT01'], 'description': 'Atropine sulfate 01 ophthalmic solution', 'armGroupLabels': ['Test Arm 1']}, {'name': 'Atropine Sulfate 02', 'type': 'DRUG', 'otherNames': ['LPTAT02'], 'description': 'Atropine sulfate 02 ophthalmic solution', 'armGroupLabels': ['Test Arm 2']}, {'name': 'Atropine Sulfate 03', 'type': 'DRUG', 'otherNames': ['LPTAT03'], 'description': 'Atropine sulfate 03 ophthalmic solution', 'armGroupLabels': ['Test Arm 3']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['LPTAT04'], 'description': 'Placebo ophthalmic solution', 'armGroupLabels': ['Reference Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '49241', 'city': 'Busan', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Choi', 'role': 'CONTACT'}], 'facility': 'Pusan National University Hospital', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'city': 'Busan', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Moon', 'role': 'CONTACT'}], 'facility': 'Inje University Busan Paik Hospital', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'city': 'Chuncheon', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Yoo', 'role': 'CONTACT'}], 'facility': 'Kangwon National University Hospital', 'geoPoint': {'lat': 37.87472, 'lon': 127.73417}}, {'city': 'Daejeon', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Lee', 'role': 'CONTACT'}], 'facility': 'Chungnam National University Hospital', 'geoPoint': {'lat': 36.34913, 'lon': 127.38493}}, {'city': 'Gwangmyeong', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Kim', 'role': 'CONTACT'}], 'facility': 'Chung-Ang University Gwang Myeong hospital', 'geoPoint': {'lat': 37.47722, 'lon': 126.86639}}, {'zip': '21565', 'city': 'Incheon', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Paik', 'role': 'CONTACT'}], 'facility': 'Gachon University Gil Hospital', 'geoPoint': {'lat': 37.45646, 'lon': 126.70515}}, {'city': 'Incheon', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Kim', 'role': 'CONTACT'}], 'facility': 'HanGil Eye Hospital', 'geoPoint': {'lat': 37.45646, 'lon': 126.70515}}, {'city': 'Seongnam-si', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Yang', 'role': 'CONTACT'}], 'facility': 'Seoul National University Bundang Hospital', 'geoPoint': {'lat': 37.43861, 'lon': 127.13778}}, {'zip': '07301', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Baek', 'role': 'CONTACT'}], 'facility': "Kim'S Eye Hospital", 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Oh', 'role': 'CONTACT'}], 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Lee', 'role': 'CONTACT'}], 'facility': 'Seoul Asan Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Kim', 'role': 'CONTACT'}], 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Shin', 'role': 'CONTACT'}], 'facility': "The Catholic University of Korea Seoul St. Mary's Hospital", 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Suwon', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Chung', 'role': 'CONTACT'}], 'facility': 'Ajou University Hospital', 'geoPoint': {'lat': 37.29111, 'lon': 127.00889}}, {'city': 'Yŏngin', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Seo', 'role': 'CONTACT'}], 'facility': 'Yongin Severance Hospital', 'geoPoint': {'lat': 36.8553, 'lon': 126.9537}}], 'centralContacts': [{'name': 'GH KIM', 'role': 'CONTACT', 'email': 'ghkim@litepharm.com', 'phone': '82-70-8805-9682'}], 'overallOfficials': [{'name': 'Sei Yeul Oh', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Samsung Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'LitePharmTech Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}