Ignite Creation Date:
2025-12-24 @ 9:34 PM
Ignite Modification Date:
2026-01-05 @ 6:27 PM
Study NCT ID:
NCT03106532
Status:
COMPLETED
Last Update Posted:
2018-10-26
First Post:
2017-03-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of PHP-201 Ophthalmic Solution in Patients With Normal Tension Glaucoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D057066', 'term': 'Low Tension Glaucoma'}], 'ancestors': [{'id': 'D005901', 'term': 'Glaucoma'}, {'id': 'D009798', 'term': 'Ocular Hypertension'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D009901', 'term': 'Optic Nerve Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000723048', 'term': 'sovesudil'}, {'id': 'D009883', 'term': 'Ophthalmic Solutions'}], 'ancestors': [{'id': 'D019999', 'term': 'Pharmaceutical Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D020313', 'term': 'Specialty Uses of Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 119}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-03-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2018-05-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-25', 'studyFirstSubmitDate': '2017-03-30', 'studyFirstSubmitQcDate': '2017-04-07', 'lastUpdatePostDateStruct': {'date': '2018-10-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-05-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean diurnal IOP change', 'timeFrame': '4 weeks', 'description': 'Mean diurnal IOP change from baseline at post-treatment time point of 4 weeks'}], 'secondaryOutcomes': [{'measure': 'The number of patient with adverse events', 'timeFrame': '28 days', 'description': 'The number of patient with adverse events including ocular adverse events'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Normal Tension Glaucoma']}, 'descriptionModule': {'briefSummary': 'Evaluation of the optimal dose for the efficacy in reduction of intraocular pressure and safety of PHP-201 ophthalmic solution in patients with normal tension glaucoma', 'detailedDescription': 'Data collection (electronic case report forms), Data dictionary (MedDRA)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 19 years and older, female and male\n* IOP ≤21 mmHg\n* Subject showing open angle finding, glaucomatous optic nerve damage and visual field defects\n* BCVA ≥+0.2\n\nExclusion Criteria:\n\n* Subject with the disease and surgery history that are not eligible to participate (acute closed angle glaucoma, narrow angle glaucoma, advanced glaucomatous loss, ocular trauma, eye surgery or laser surgery, unstable angina, myocardial infarction, uncontrolled hypertension and diabetes, etc)\n* Subject who can't discontinue contact lenses\n* Subject who can't discontinue topical/systemic IOP lowering medication"}, 'identificationModule': {'nctId': 'NCT03106532', 'briefTitle': 'Evaluation of PHP-201 Ophthalmic Solution in Patients With Normal Tension Glaucoma', 'organization': {'class': 'INDUSTRY', 'fullName': 'pH Pharma'}, 'officialTitle': 'A Multicenter, Randomized, Placebo-controlled, Double-blind, Dose-finding Phase 2 Clinical Trial to Evaluate the Efficacy in Reduction of Intraocular Pressure and Safety of PHP-201 in Patients With Normal Tension Glaucoma', 'orgStudyIdInfo': {'id': 'PHP-201-S203'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PHP-201 0.25% ophthalmic solution', 'description': 'PHP-201 0.25% ophthalmic solution, TID', 'interventionNames': ['Drug: PHP-201 0.25% ophthalmic solution']}, {'type': 'EXPERIMENTAL', 'label': 'PHP-201 0.5% ophthalmic solution', 'description': 'PHP-201 0.5% ophthalmic solution, TID', 'interventionNames': ['Drug: PHP-201 0.5% ophthalmic solution']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo ophthalmic solution', 'description': 'Placebo ophthalmic solution, TID', 'interventionNames': ['Drug: Placebo ophthalmic solution']}], 'interventions': [{'name': 'PHP-201 0.25% ophthalmic solution', 'type': 'DRUG', 'otherNames': ['PHP-201'], 'description': '3 drops daily, 28 days', 'armGroupLabels': ['PHP-201 0.25% ophthalmic solution']}, {'name': 'PHP-201 0.5% ophthalmic solution', 'type': 'DRUG', 'otherNames': ['PHP-201'], 'description': '3 drops daily, 28 days', 'armGroupLabels': ['PHP-201 0.5% ophthalmic solution']}, {'name': 'Placebo ophthalmic solution', 'type': 'DRUG', 'otherNames': ['PHP-201'], 'description': '3 drops daily, 28 days', 'armGroupLabels': ['Placebo ophthalmic solution']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'pH Pharma', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}