Ignite Creation Date:
2025-12-24 @ 12:45 PM
Ignite Modification Date:
2025-12-27 @ 10:13 PM
Study NCT ID:
NCT04647461
Status:
UNKNOWN
Last Update Posted:
2020-12-01
First Post:
2020-11-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Efficacy and Ocular Surface Disease Assessment Between BRIDIN-T Eye Drops 0.15% and ALPHAGAN-P Eye Drops 0.15% in Glaucoma or Ocular Hypertensive Patients : Phase 4, Parallel Group Design, Investigator-blind, Active-control, Randomized, Multi-center Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005901', 'term': 'Glaucoma'}], 'ancestors': [{'id': 'D009798', 'term': 'Ocular Hypertension'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068438', 'term': 'Brimonidine Tartrate'}], 'ancestors': [{'id': 'D011810', 'term': 'Quinoxalines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 61}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2019-03-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2021-01-29', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-11-23', 'studyFirstSubmitDate': '2020-11-23', 'studyFirstSubmitQcDate': '2020-11-23', 'lastUpdatePostDateStruct': {'date': '2020-12-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01-29', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Corneal staining test', 'timeFrame': 'Administered 12 weeks after', 'description': 'The degree of staining of the cornea after blue fluorescein staining under the slit lamp illumination of a cobalt blue light source using a yellow filter was evaluated on a 6 point scale according to the oxford grading system'}, {'measure': 'Conjunctival staining test', 'timeFrame': 'Administered 12 weeks after', 'description': 'After lysamine green staining under slit lamps, the conjunctiva was divided into the nasal side and the lateral side, and the degree of nasal conjunctiva and bilateral conjunctival staining was evaluated on a 6-point scale according to the oxford grading system'}, {'measure': 'Ocular surface disease index (OSDI)', 'timeFrame': 'Administered 12 weeks after', 'description': 'The ocular surface disease index was assessed for ocular surface disease, including visual function (five items), eye symptoms (four items), and environmental factors (three items) , 0 point for no symptoms, 1 point for occasional symptoms, 2 points for symptoms of half a day, 3 points for most symptoms, and 4 points for symptoms during the whole day.'}, {'measure': 'Questionnaire (Evaluation of Satisfaction with Medication, Ocular tolerance)', 'timeFrame': 'Administered 12 weeks after', 'description': 'The evaluation of satisfaction with medication is conducted with a questionnaire evaluation on the convenience of use, storage of investigational product, and the ocular tolerance.\n\nEvaluation is conducted on 8 symptoms of tingling/hot, sticky, itchy, blurred vision, foreign body sensation, dryness, glare, and pain. Assess the severity of symptoms (0-3 points) and duration of symptoms (immediate, continuous)'}], 'secondaryOutcomes': [{'measure': 'Corneal staining test', 'timeFrame': 'Administered 4 weeks after', 'description': 'The degree of staining of the cornea after blue fluorescein staining under the slit lamp illumination of a cobalt blue light source using a yellow filter was evaluated on a 6 point scale according to the oxford grading system'}, {'measure': 'Conjunctival staining test', 'timeFrame': 'Administered 4 weeks after', 'description': 'After lysamine green staining under slit lamps, the conjunctiva was divided into the nasal side and the lateral side, and the degree of nasal conjunctiva and bilateral conjunctival staining was evaluated on a 6-point scale according to the oxford grading system'}, {'measure': 'Ocular surface disease index (OSDI)', 'timeFrame': 'Administered 4 weeks after', 'description': 'The ocular surface disease index was assessed for ocular surface disease, including visual function (five items), eye symptoms (four items), and environmental factors (three items) , 0 point for no symptoms, 1 point for occasional symptoms, 2 points for symptoms of half a day, 3 points for most symptoms, and 4 points for symptoms during the whole day.'}, {'measure': 'IOP(Intraocular pressure)', 'timeFrame': 'Administered 4, 12 weeks after', 'description': 'IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and measured in millimeters of mercury (mmHg). Data at 10:00 AM from Weeks 4, 8, and 12 were pooled. A more negative change indicates a greater amount of improvement. One eye (study eye) was subject to analysis.'}, {'measure': 'Tear break up time (TBUT)', 'timeFrame': 'Administered 4, 12 weeks after', 'description': 'After blinking blue fluorescein staining of the cobalt blue light source using a yellow filter, it was observed from the blinking point that there was a black spot, a streak pattern or a fluorine defect in the fluorescein-tear layer Was measured in seconds. The measurement results were repeated three times and average values were used.'}, {'measure': 'Slit Lamp Biomicroscopy Findings - Limbal Redness', 'timeFrame': 'Administered 4, 12 weeks after', 'description': 'Slit lamp Biomicroscopy findings will be assessed on Efron Grading scales scored to the nearest 0.1 on a scale of 0 - 4 (0=normal, 1=trace, 2=mild, 3=moderate, 4=severe).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Glaucoma', 'Ocular Hypertensive']}, 'descriptionModule': {'briefSummary': 'Comparison of Efficacy and Ocular Surface Disease Assessment between BRIDIN-T Eye drops 0.15% and ALPHAGAN-P Eye drops 0.15% in Glaucoma or Ocular Hypertensive Patients : Phase 4, Parallel Group Design, Investigator-blind, Active-control, Randomized, Multi-center Trial', 'detailedDescription': 'Following 12 weeks of administration of BRIDIN-T Eye drops 0.15%(non preservative) or ALPHAGAN-P Eye drops 0.15%(preservatives) for patients with glaucoma or Ocular Hypertensive Patients. The use of BRIDIN-T Eye drops(non preservative) is less harmful to external ophthalmicus diseases and increase of medication compliance for ophthalmic drugs than the ALPHAGAN-P Eye drops 0.15%(preservatives)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Adult(Male or Female) over 19 years who were diagnosed with glaucoma or ocular hypertension\n2. In the case of a person receiving a glaucoma treatment drug, a person who has completed the appropriate in wash-out period for the existing glaucoma drug before the investigational product is administered.\n3. Intraocular pressure (IOP) \\>/= 15mmHg and \\< 40mmHg in each eye using Goldmann applanation tonometry at visit 2\n4. Written consent voluntarily to participate in this clinical trial\n\nExclusion Criteria:\n\n1. Patients with primary closed-angle glaucoma, congenital glaucoma and secondary glaucoma caused by steroid drugs, etc.\n2. BCVA (best-corrected visual acuity) Snellen equivalent of Snellen 20/80(logMar 0.25) or less.\n3. Those who have ongoing medical history as intraocular inflamation.\n4. Central corneal thickness is not between 470um and 591um.\n5. Patients who have received lacrimal passive occlusion within the last three months or who have surgery plans during the clinical trial period.\n6. Pregnant or nursing women.\n7. Patients judged coexisting disease that could interfere with the completion of the treatment or safety of this clinical trial. Patients that other researchers are determined inadequately'}, 'identificationModule': {'nctId': 'NCT04647461', 'briefTitle': 'Comparison of Efficacy and Ocular Surface Disease Assessment Between BRIDIN-T Eye Drops 0.15% and ALPHAGAN-P Eye Drops 0.15% in Glaucoma or Ocular Hypertensive Patients : Phase 4, Parallel Group Design, Investigator-blind, Active-control, Randomized, Multi-center Trial', 'organization': {'class': 'OTHER', 'fullName': 'CHA University'}, 'officialTitle': 'Comparison of Efficacy and Ocular Surface Disease Assessment Between BRIDIN-T Eye Drops 0.15% and ALPHAGAN-P Eye Drops 0.15% in Glaucoma or Ocular Hypertensive Patients : Phase 4, Parallel Group Design, Investigator-blind, Active-control, Randomized, Multi-center Trial', 'orgStudyIdInfo': {'id': 'BAT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BRIDIN-T Eye drops 0.15%(Non preservative)', 'description': 'Brimonidine Tartrate 1.5mg : 1 drop 3 times a day for 12 weeks to target eyes', 'interventionNames': ['Drug: Brimonidine Tartrate 1.5mg']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'ALPHAGAN-P Eye drops 0.15%(Preservatives)', 'description': 'Brimonidine Tartrate 1.5mg : 1 drop 3 times a day for 12 weeks to target eyes', 'interventionNames': ['Drug: Brimonidine Tartrate 1.5mg']}], 'interventions': [{'name': 'Brimonidine Tartrate 1.5mg', 'type': 'DRUG', 'otherNames': ['BRIDIN-T Eye drops 0.15%'], 'description': '1 drop 3 times a day for 12 weeks to target eyes', 'armGroupLabels': ['BRIDIN-T Eye drops 0.15%(Non preservative)']}, {'name': 'Brimonidine Tartrate 1.5mg', 'type': 'DRUG', 'otherNames': ['ALPHAGAN-P Eye drops 0.15%'], 'description': '1 drop 3 times a day for 12 weeks to target eyes', 'armGroupLabels': ['ALPHAGAN-P Eye drops 0.15%(Preservatives)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13497', 'city': 'Seongnam', 'state': 'Bundang-gu', 'country': 'South Korea', 'facility': 'CHA University Bundang Medical Center', 'geoPoint': {'lat': 35.54127, 'lon': 127.39683}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CHA University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hanlim Pharm. Co., Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor., M.D., Ph.D.', 'investigatorFullName': 'Seungsoo Rho', 'investigatorAffiliation': 'CHA University'}}}}