Ignite Creation Date:
2025-12-24 @ 9:11 PM
Ignite Modification Date:
2025-12-26 @ 5:13 PM
Study NCT ID:
NCT05794204
Status:
COMPLETED
Last Update Posted:
2024-12-06
First Post:
2023-03-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
RMP-A03 Ocular Suspension in Patients With Pterygium
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011625', 'term': 'Pterygium'}], 'ancestors': [{'id': 'D003229', 'term': 'Conjunctival Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Sponsor/CRO clinical operations team will also be masked. Sponsor/CRO biostats team and drug supply manager will be unmasked.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Patients will be randomized in a 1:1:1 fashion'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 77}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-06-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'dispFirstSubmitDate': '2024-12-02', 'completionDateStruct': {'date': '2024-01-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-03', 'studyFirstSubmitDate': '2023-03-20', 'studyFirstSubmitQcDate': '2023-03-20', 'dispFirstPostDateStruct': {'date': '2024-04-16', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2024-12-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in pterygium hyperemia grading at Day 28', 'timeFrame': '28 days', 'description': 'Pterygium hyperemia grading will be assessed by the principal investigator based on predefined vascularity scale.'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in pterygium characteristics at Day 28', 'timeFrame': '28 days', 'description': 'Pterygium size will be measured by the principal investigator based on predefined scale'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pterygium']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to test the safety and efficacy of an ocular medication on the treatment of pterygium.', 'detailedDescription': 'Following informed consent, patients with pterygium who meet all eligibility criteria will be randomized to an 84-day double-blinded study to measure the safety and efficacy of the study drug as compared to placebo.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Must be at least 18 years old\n* Diagnosis of pterygium with specified characteristics\n* BCVA of 20/200 or better\n* Willingness to attend all study visits and comply with the study procedures\n\nExclusion Criteria:\n\n* Presence of ocular disease\n* Double pterygium\n* History of ocular surgery\n* Presence of ocular trauma\n* Use of any ocular medication\n* Use of contact lens\n* Allergy to any of the components of study drug\n* Cannot properly administer study drug\n* Clinically significant systemic disease that may place the subject at risk or confound study results\n* Participation in an investigational study within 30 days prior to screening\n* Female participants who are pregnant, nursing, planning a pregnancy, or not using a medically acceptable form of birth control (WOCBP).'}, 'identificationModule': {'nctId': 'NCT05794204', 'briefTitle': 'RMP-A03 Ocular Suspension in Patients With Pterygium', 'organization': {'class': 'INDUSTRY', 'fullName': 'Suzhou Raymon Pharmaceuticals Company, Ltd.'}, 'officialTitle': 'A Phase 2a Study Evaluating the Safety and Efficacy of RMP-A03 Ocular Suspension in Patients With Pterygium', 'orgStudyIdInfo': {'id': 'RMP-A03-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patients randomized to dose 1 study drug', 'description': 'Approximately 25 patients randomized to dose 1 of RMP-A03', 'interventionNames': ['Drug: RMP-A03 - Dose 1']}, {'type': 'EXPERIMENTAL', 'label': 'Patients randomized to dose 2 of study drug', 'description': 'Approximately 25 patients randomized to dose 2 of RMP-A03', 'interventionNames': ['Drug: RMP-A03 - Dose 2']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Patients randomized to placebo', 'description': 'Approximately 25 patients randomized to placebo.', 'interventionNames': ['Drug: RMP-A03 Placebo']}], 'interventions': [{'name': 'RMP-A03 - Dose 1', 'type': 'DRUG', 'description': 'Patients will randomized to low dose of RMP-A03', 'armGroupLabels': ['Patients randomized to dose 1 study drug']}, {'name': 'RMP-A03 - Dose 2', 'type': 'DRUG', 'description': 'Patients will be randomized to high dose of RMP-A03', 'armGroupLabels': ['Patients randomized to dose 2 of study drug']}, {'name': 'RMP-A03 Placebo', 'type': 'DRUG', 'description': 'Patients will be randomized to RMP-A03 Placebo', 'armGroupLabels': ['Patients randomized to placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91204', 'city': 'Glendale', 'state': 'California', 'country': 'United States', 'facility': 'Global Research Management', 'geoPoint': {'lat': 34.14251, 'lon': -118.25508}}, {'zip': '90301', 'city': 'Inglewood', 'state': 'California', 'country': 'United States', 'facility': 'United Medical Research Institute', 'geoPoint': {'lat': 33.96168, 'lon': -118.35313}}, {'zip': '92663', 'city': 'Newport Beach', 'state': 'California', 'country': 'United States', 'facility': 'Eye Research Foundation Inc', 'geoPoint': {'lat': 33.61891, 'lon': -117.92895}}, {'zip': '33144', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Oceane7 Medical & Research Center Inc.', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '37215', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Toyos Clinic', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '78731', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Keystone Research', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Suzhou Raymon Pharmaceuticals Company, Ltd.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'WuXi Clinical', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}