Ignite Creation Date:
2025-12-24 @ 9:06 PM
Ignite Modification Date:
2026-01-02 @ 2:18 AM
Study NCT ID:
NCT05245604
Status:
UNKNOWN
Last Update Posted:
2022-02-18
First Post:
2022-02-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluating the Efficacy and Safety of TJO-087 in Moderate to Severe 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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 182}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-06-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2023-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-02-08', 'studyFirstSubmitDate': '2022-02-08', 'studyFirstSubmitQcDate': '2022-02-08', 'lastUpdatePostDateStruct': {'date': '2022-02-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Non-anesthetic Schirmer Test at Week 32', 'timeFrame': 'Baseline and Week 32', 'description': 'The Schirmer test without anesthesia was used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Non-anesthetic Schirmer Test at Week 8, 16, 24', 'timeFrame': 'Baseline, Week 8, 16 and 24', 'description': 'The Schirmer test without anesthesia was used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac.'}, {'measure': 'Change From Baseline in Corneal Fluorescein Staining Score at Week 8, 16, 24 and 32', 'timeFrame': 'Baseline, Week 8, 16, 24 and 32', 'description': 'Change from Baseline in corneal staining of the worse eye using blue fluorescein staining procedure.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dry Eye Syndrome']}, 'referencesModule': {'references': [{'pmid': '36450107', 'type': 'DERIVED', 'citation': 'Eom Y, Yoon KC, Kim HK, Song JS, Hyon JY, Kim HM. A Multicenter, Randomized, Double-Blind Evaluation of the Efficacy of TJO-087 Versus 0.05% Cyclosporine A in Moderate to Severe Dry Eye. J Ocul Pharmacol Ther. 2023 Jan-Feb;39(1):27-35. doi: 10.1089/jop.2022.0119. Epub 2022 Nov 24.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this clinical study is to prove that the test drug (TJO-087) is not clinically inferior to the control drug after 32 weeks of administration to patients with suppressed tear production due to moderate or severe dry eye syndrome.'}, '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* Patients with moderate to severe dry eye\n* Screening both eyes, the corrected visual acuity is 0.2 or more\n* Written informed consent to participate in the trial\n\nExclusion Criteria:\n\n* Screening visits within 2 weeks who treated with topical NSAIDs/hyaluronate sodium ophthalmic solutions\n* Screening visits within 2 months the patients with systemic or ocular disorders affected the test results (ocular surgery, trauma, or disease)\n* Intraocular pressure(IOP)\\> 25 mmHg\n* Patient using or to use punctual plug within 1 months.\n* Patients with contact lens.'}, 'identificationModule': {'nctId': 'NCT05245604', 'briefTitle': 'Evaluating the Efficacy and Safety of TJO-087 in Moderate to Severe Dry Eye Disease Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Taejoon Pharmaceutical Co., Ltd.'}, 'officialTitle': 'A Phase Ⅲ, Multicenter, Randomized, Double-blind, Active-controlled, Parallel Study of TJO-087 for Evaluating 32 Weeks Safety and Efficacy in Moderate to Severe Dry Eye Disease Patients', 'orgStudyIdInfo': {'id': 'TJO-087-301'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TJO-087', 'interventionNames': ['Drug: TJO-087']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Cyclosporine 0.05%', 'interventionNames': ['Drug: Cyclosporine ophthalmic solution 0.05%']}], 'interventions': [{'name': 'TJO-087', 'type': 'DRUG', 'description': 'Cyclosporine ophthalmic nano-emulsion 0.08%, 1 drop once daily', 'armGroupLabels': ['TJO-087']}, {'name': 'Cyclosporine ophthalmic solution 0.05%', 'type': 'DRUG', 'description': 'Cyclosporine ophthalmic solution 0.05%, 1 drop twice/day', 'armGroupLabels': ['Cyclosporine 0.05%']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Hyo Myung Kim, MD, PhD', 'role': 'CONTACT'}], 'facility': 'Hyo Myung, Kim', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Sukyoung Kwon', 'role': 'CONTACT', 'email': 'skkwon@taejoon.co.kr', 'phone': '82-2-799-0184'}], 'overallOfficials': [{'name': 'Hyo Myung Kim, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Korea University Anam Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Taejoon Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}