Ignite Creation Date:
2025-12-24 @ 4:27 PM
Ignite Modification Date:
2026-01-24 @ 6:28 AM
Study NCT ID:
NCT01670266
Status:
COMPLETED
Last Update Posted:
2013-06-03
First Post:
2012-08-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Single and Multiple Dose Escalation and Two-sequence Crossover Study of ONO-9054 in Patients With Ocular Hypertension or Mild Open-angle Glaucoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009798', 'term': 'Ocular Hypertension'}, {'id': 'D005902', 'term': 'Glaucoma, Open-Angle'}, {'id': 'D005901', 'term': 'Glaucoma'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000607345', 'term': 'propan-2-yl 4-(6-(4-(2,5-difluorophenoxy)-3-hydroxybut-1-en-1-yl)-7-hydroxyoctahydro-2H-cyclopenta(b)oxepin-3-yl)butanoate'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-05', 'lastUpdateSubmitDate': '2013-05-31', 'studyFirstSubmitDate': '2012-08-15', 'studyFirstSubmitQcDate': '2012-08-17', 'lastUpdatePostDateStruct': {'date': '2013-06-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-08-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety and tolerability of ONO-9054', 'timeFrame': 'up to 14 days', 'description': 'Safety and tolerability of ONO-9054 will be measured using vital signs, ECGs, laboratory tests, ocular exams, physical examination and incidence/severity of adverse events over a dosing period of up to 14 days'}], 'secondaryOutcomes': [{'measure': 'Characterization of PK profiles', 'timeFrame': 'up to 14 days', 'description': 'The mean concentrations of ONO-9054 and its active metabolite will be measured in plasma in order to determine peak and trough levels over a dosing period of 14 days'}, {'measure': 'Evaluation of PD measurements', 'timeFrame': 'up to 14 days', 'description': 'The pharmacodynamic measurement will be intraocular pressure. Relative changes with respect to baseline will be assessed after 14 days of administration under both AM and PM dosing conditions.'}, {'measure': 'Comparison of safety, tolerability between once daily morning and once daily evening', 'timeFrame': '14 days', 'description': 'Safety and tolerability of a single concentration will be evaluated by review of adverse events and any change from baseline in ocular symptoms in a crossover arm in which the active drug is administered for 14 days under both AM and PM dosing conditions.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['ONO-9054', 'ocular hypertension', 'OHT', 'Open angle-glaucoma', 'OAG', 'Glaucoma', 'Eye diseases'], 'conditions': ['Ocular Hypertension (OHT)', 'Mild Open Angle-glaucoma (OAG)']}, 'referencesModule': {'references': [{'pmid': '26453641', 'type': 'DERIVED', 'citation': 'Berlin MS, Rowe-Rendleman C, Ahmed I, Ross DT, Fujii A, Ouchi T, Quach C, Wood A, Ward CL. EP3/FP dual receptor agonist ONO-9054 administered morning or evening to patients with open-angle glaucoma or ocular hypertension: results of a randomised crossover study. Br J Ophthalmol. 2016 Jun;100(6):843-7. doi: 10.1136/bjophthalmol-2015-307000. Epub 2015 Oct 9.'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to evaluate the safety and tolerability of 3 planned doses of ONO-9054 in the eyes of adult male and female patients with ocular hypertension (OHT) or mild open angle-glaucoma (OAG).\n\nThe secondary objectives are to evaluate Pharmacodynamics (PD) and to characterize the pharmacokinetic (PK) profile of ONO-9054 and its metabolite in plasma and to compare its tolerability following morning and evening dosing.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female subjects age 18-80 (inclusive) with confirmed diagnosis of OHT or OAG\n* Confirmed diagnosis of bilateral OHT or chronic open-angle glaucoma\n* Able to undergo washout of all ocular drugs\n* An IOP ≥ 22mmHg at 8:00 AM and ≥ 21 mmHg at 10:00 AM in at least one eye; but ≤ 35 mmHg at all time points in both eyes on Day -2 and Day -1\n* Central corneal thickness 500-600 µm at screening in both eyes\n* BCVA 20/100 or better in both eyes\n\nExclusion Criteria:\n\n* Any history of severe ocular trauma in either eye at any time\n* Any history of previous intraocular or ocular laser surgery within the past 3 months or any refractive surgery procedure within the past 6 months of screening visit in the study eye(s)\n* Cataracts that prevent observation of the fundus in either eye'}, 'identificationModule': {'nctId': 'NCT01670266', 'briefTitle': 'Single and Multiple Dose Escalation and Two-sequence Crossover Study of ONO-9054 in Patients With Ocular Hypertension or Mild Open-angle Glaucoma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ono Pharmaceutical Co. Ltd'}, 'officialTitle': 'A Double-masked, Placebo-controlled, Dose-escalation Study and Double-masked, Two-sequence, Crossover Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ONO-9054 in Patients With Ocular Hypertension or Mild Open-Angle Glaucoma', 'orgStudyIdInfo': {'id': 'ONO-9054IOU002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental Arm 1', 'description': 'Experimental Eye drops 3.0 µg/mL QD both eyes on Day 1, 5-18', 'interventionNames': ['Drug: ONO-9054']}, {'type': 'EXPERIMENTAL', 'label': 'Experimental Arm 2', 'description': 'Experimental Eye drops 10.0 µg/mL QD both eyes on Day 1, 5-18', 'interventionNames': ['Drug: ONO-9054']}, {'type': 'EXPERIMENTAL', 'label': 'Experimental Arm 3', 'description': 'Experimental Eye drop 30.0 µg/mL QD both eyes on day 1, 5-18', 'interventionNames': ['Drug: ONO-9054']}, {'type': 'EXPERIMENTAL', 'label': 'Experimental Arm 4', 'description': 'Experimental Eye drop, 2 sequence crossover Cohort \\[1 dose; 1-30 µg/mL\\]to be determined and placebo', 'interventionNames': ['Drug: ONO-9054', 'Drug: Placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Arm', 'description': 'Matched placebo eye drops dosed in same manner as ONO-9054', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'ONO-9054', 'type': 'DRUG', 'armGroupLabels': ['Experimental Arm 1', 'Experimental Arm 2', 'Experimental Arm 3', 'Experimental Arm 4']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Experimental Arm 4', 'Placebo Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92626', 'city': 'Costa Mesa', 'state': 'California', 'country': 'United States', 'facility': 'Costa Mesa Clinical Site', 'geoPoint': {'lat': 33.64113, 'lon': -117.91867}}, {'zip': '92663', 'city': 'Newport Beach', 'state': 'California', 'country': 'United States', 'facility': 'Newport Beach (satellite site)', 'geoPoint': {'lat': 33.61891, 'lon': -117.92895}}, {'zip': '92705', 'city': 'Santa Ana', 'state': 'California', 'country': 'United States', 'facility': 'Santa Ana (satellite site)', 'geoPoint': {'lat': 33.74557, 'lon': -117.86783}}], 'overallOfficials': [{'name': 'Ono Pharma USA, Inc.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ono Pharmaceutical Co. Ltd'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ono Pharma USA Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}