Ignite Creation Date:
2025-12-25 @ 1:38 AM
Ignite Modification Date:
2025-12-26 @ 1:24 AM
Study NCT ID:
NCT06291194
Status:
RECRUITING
Last Update Posted:
2024-04-08
First Post:
2024-02-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of AJU-S56 5% in Dry Eye Syndrome Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015352', 'term': 'Dry Eye Syndromes'}], 'ancestors': [{'id': 'D007766', 'term': 'Lacrimal Apparatus Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, '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': 396}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-11-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2024-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-04', 'studyFirstSubmitDate': '2024-02-27', 'studyFirstSubmitQcDate': '2024-03-01', 'lastUpdatePostDateStruct': {'date': '2024-04-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total corneal staining score (TCSS)', 'timeFrame': 'WEEK 4, 8, 12', 'description': 'TCSS ≥4 at baseline (Total Max score : 15)'}], 'secondaryOutcomes': [{'measure': 'LGCSS', 'timeFrame': 'WEEK 4, 8, 12', 'description': 'Lissamine Green Conjunctival Staining Score(Total score : 0\\~18)'}, {'measure': 'TFBUT', 'timeFrame': 'WEEK 4, 8, 12', 'description': 'Tear Film Break Up Time'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Dry eye'], 'conditions': ['Dry Eye Syndromes']}, 'descriptionModule': {'briefSummary': 'This study is planned to Evaluate the Efficacy and Safety of test drug (AJU-S56 5%) compared to control drug(vehicle) in Patients with Dry Eye Disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and Female who over 19 years old\n* Moderate to Severe Dry Eye Disease Patients\n* Must meet all criteria listed below at least in one eye or both eyes.\n\n 1. TCSS (National eye institute (NEI) scale)≥ 4\n 2. Ocular discomfort score (ODS) ≥ 3\n 3. Schirmer test(without anesthesia) ≤ 10mm in 5 mins\n 4. Tear break-up time ≤ 6 secs\n* Written informed consent to participate in the trial\n\nExclusion Criteria:\n\n* Those who have clinically significant eye disease not related to dry eye syndrome\n* Those who have worn contact lenses before 1week Screening visit or have to wear contact lenses or need to wear contact lenses during study period\n* Those who have medical history with intraocular surgery 12months before screening visit\n* Use of corticosteroid, beta blocker and anticholinergic agent within 4 weeks\n* Participation in other studies within 4weeks of screening visit'}, 'identificationModule': {'nctId': 'NCT06291194', 'briefTitle': 'Efficacy and Safety of AJU-S56 5% in Dry Eye Syndrome Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'AJU Pharm Co., Ltd.'}, 'officialTitle': 'The Purpose of This Clinical Study is to Prove That the Test Drug (AJU-S56 5%) is Superior to the Control Drug After 24 Weeks of Administration to Patients Who Have Moderate or Severe Dry Eye Syndrome', 'orgStudyIdInfo': {'id': '22DE30902'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Test group(AJU-S56 5%)', 'description': 'QID(4 times in a day) for 24 Weeks after Randomization', 'interventionNames': ['Drug: AJU-S56 5%']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo group(Vehicle)', 'description': 'QID(4 times in a day) for 24 Weeks after Randomization', 'interventionNames': ['Drug: Placebo Group(Vehicle)']}], 'interventions': [{'name': 'AJU-S56 5%', 'type': 'DRUG', 'otherNames': ['Test Group'], 'description': 'After Randomization(Week 0), Participants will be administered with the durg, QID(4 times in a day, and 1 drop per each times) until end of trial(Week 24).', 'armGroupLabels': ['Test group(AJU-S56 5%)']}, {'name': 'Placebo Group(Vehicle)', 'type': 'DRUG', 'otherNames': ['Control Group'], 'description': 'After Randomization(Week 0), Participants will be administered with the durg, QID(4 times in a day, and 1 drop per each times) until end of trial(Week 24).', 'armGroupLabels': ['Placebo group(Vehicle)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'JUNGMIN LEE', 'role': 'CONTACT', 'email': 'ajuf13001@ajupharm.co.kr', 'phone': '+82-02-2630-0700'}], 'facility': 'AJU Pharm Co., Ltd.', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'JUNNGMIN LEE', 'role': 'CONTACT', 'email': 'ajuf13001@ajupharm.co.kr', 'phone': '+82-02-2630-0700'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AJU Pharm Co., Ltd.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'GL Pharm Tech Corporation', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}