Ignite Creation Date:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2026-01-04 @ 9:38 PM
Study NCT ID:
NCT04127851
Status:
COMPLETED
Last Update Posted:
2022-06-08
First Post:
2019-10-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluating HA 0.15% Compared With Cyclosporine 0.05%, and Efficacy of Combination Therapy in Dry Eye Disease 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': 'D003524', 'term': 'Cyclosporins'}, {'id': 'D059039', 'term': 'Standard of Care'}, {'id': 'C035361', 'term': 'MCC protocol'}], 'ancestors': [{'id': 'D010456', 'term': 'Peptides, Cyclic'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A Multicenter, Randomized, Single-blind Study for Evaluating the Efficacy of HA 0.15% Compared with Cyclosporine 0.05% in Moderate to Severe Dry Eye Syndrome'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 438}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-11-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2021-10-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-06-06', 'studyFirstSubmitDate': '2019-10-14', 'studyFirstSubmitQcDate': '2019-10-14', 'lastUpdatePostDateStruct': {'date': '2022-06-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Corneal Staining Score at Week 12', 'timeFrame': 'Baseline and Week 12', 'description': 'After 12 weeks of administration of the drugs compare the therapeutic effectiveness between control drug and trial drug evaluated as the corneal staining score change.\n\n* Scale: "Oxford grading system" that divides into six groups according to severity from 0 (absent) to 5 (severe).\n* The higher scores mean a worse outcome.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Corneal Staining Score at Week 4 and Week 8', 'timeFrame': 'Baseline, Week 4 and Week 8', 'description': 'After 4, 8 weeks of administration of the drugs compare the therapeutic effectiveness between control drug and trial drug evaluated as the corneal staining score change.\n\n* Scale: "Oxford grading system" that divides into six groups according to severity from 0 (absent) to 5 (severe).\n* The higher scores mean a worse outcome.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dry Eye', 'Dry Eye Syndromes']}, 'descriptionModule': {'briefSummary': 'In patients with moderate to severe dry eye syndrome, the test drug (HA 0.15% eye drop) or the control drug (cyclosporin 0.05% eye drop) is administered for 12 weeks, and the corneal staining of each group would be evaluated. The study objective is to demonstrate that the test drug is not clinically inferior to the control drug.\n\nFurthermore, the efficacy of combination therapy would be evaluated through exploratory combination therapy group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male or female, age 20 or over\n* Moderate to Severe Dry Eye Disease Patients\n* Written informed consent to participate in the trial\n\nExclusion Criteria:\n\n* Any laser or ocular surgery within 2 months prior screening\n* Use of contact lenses\n* Any condition limiting patient's ability to participate in the trial"}, 'identificationModule': {'nctId': 'NCT04127851', 'briefTitle': 'Evaluating HA 0.15% Compared With Cyclosporine 0.05%, and Efficacy of Combination Therapy in Dry Eye Disease Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Taejoon Pharmaceutical Co., Ltd.'}, 'officialTitle': 'A Phase IV, Multicenter, Randomized, Single-blinded(Evaluator), Active-controlled, Parallel Study for Evaluating HA 0.15% Compared With Cyclosporine 0.05%, and Efficacy of Combination Therapy in Moderate to Severe Dry Eye Disease Patients', 'orgStudyIdInfo': {'id': 'TJO-018'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sodium Hyaluronate 0.15% mono-therapy', 'description': 'HA 0.15% group was treated with HA 0.15% six times daily for 12 weeks', 'interventionNames': ['Drug: TJO-018 (HA 0.15%)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Cyclosporin 0.05% + carboxymethylcellulose (CMC) 0.5% (standard therapy)', 'description': 'CsA 0.05% + CMC 0.5% group was treated with CsA 0.05% two times daily and CMC 0.5% two \\~ six times daily for 12 weeks.', 'interventionNames': ['Drug: Cyclosporine Ophthalmic Emulsion 0.05% standard therapy (CMC 0.5% add)']}, {'type': 'OTHER', 'label': 'HA 0.15% + CsA 0.05% (combination therapy)', 'description': 'HA 0.15% + CsA 0.05% group was treated with HA 0.15% six times daily and CsA 0.05% twice daily for 12 weeks.', 'interventionNames': ['Drug: TJO-018 (HA 0.15%) + Cyclosporine Ophthalmic Emulsion 0.05%']}], 'interventions': [{'name': 'TJO-018 (HA 0.15%)', 'type': 'DRUG', 'description': 'TJO-018 / one drop / 6 times daily in both eyes', 'armGroupLabels': ['Sodium Hyaluronate 0.15% mono-therapy']}, {'name': 'Cyclosporine Ophthalmic Emulsion 0.05% standard therapy (CMC 0.5% add)', 'type': 'DRUG', 'description': 'Cyclosporine / one drop / twice daily in both eyes carboxymethylcellulose (CMC) / one drop / two\\~six times daily in both eyes', 'armGroupLabels': ['Cyclosporin 0.05% + carboxymethylcellulose (CMC) 0.5% (standard therapy)']}, {'name': 'TJO-018 (HA 0.15%) + Cyclosporine Ophthalmic Emulsion 0.05%', 'type': 'DRUG', 'description': 'TJO-018 (HA0.15%)/ one drop 6 times daily in both eyes Cyclosporine 0.05% /one drop twice daily in both eyes', 'armGroupLabels': ['HA 0.15% + CsA 0.05% (combination therapy)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'Taejoon Pharmaceutical Co., Ltd.', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Taejoon Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}