Ignite Creation Date:
2025-12-25 @ 2:39 AM
Ignite Modification Date:
2026-03-02 @ 8:17 AM
Study NCT ID:
NCT02622334
Status:
COMPLETED
Last Update Posted:
2018-03-14
First Post:
2015-12-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO5093151 in Patients With Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT).
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': 'D000077338', 'term': 'Latanoprost'}], 'ancestors': [{'id': 'D011461', 'term': 'Prostaglandins F, Synthetic'}, {'id': 'D011465', 'term': 'Prostaglandins, Synthetic'}, {'id': 'D011453', 'term': 'Prostaglandins'}, {'id': 'D015777', 'term': 'Eicosanoids'}, {'id': 'D005231', 'term': 'Fatty Acids, Unsaturated'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D012898', 'term': 'Autacoids'}, {'id': 'D018836', 'term': 'Inflammation Mediators'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-12-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2016-07-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-03-13', 'studyFirstSubmitDate': '2015-12-02', 'studyFirstSubmitQcDate': '2015-12-02', 'lastUpdatePostDateStruct': {'date': '2018-03-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-12-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-07-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of adverse events', 'timeFrame': 'Up to 12 weeks'}, {'measure': 'Changes in vital signs, electrocardiogram (ECG), opthalmologic assessments, and clinical laboratory results', 'timeFrame': 'Up to 12 weeks'}, {'measure': 'Change in mean IOP after 7 days treatment vs baseline: change from baseline for RO5093151 and latanoprost and difference in change from baseline between RO5093151 and latanoprost', 'timeFrame': 'Baseline (Day 1) and Day 8'}], 'secondaryOutcomes': [{'measure': 'Change in IOP at matched clock-times after 7 days of treatment vs baseline (diurnal IOP) and between RO5093151 and latanoprost', 'timeFrame': 'Baseline and Day 8'}, {'measure': 'Maximum observed plasma concentration (Cmax)', 'timeFrame': 'Day 1: Pre-dose (morning); 30 minutes, 1, 4, 8, 11 (evening pre-dose) and 12 hours post-dose; Day 7: Pre-dose (evening), 1, 12 (Day 8), 16 (Day 8), 20 (Day 8) hours post-dose'}, {'measure': 'Time to maximum observed plasma concentration (Tmax)', 'timeFrame': 'Day 1: Pre-dose (morning); 30 minutes, 1, 4, 8, 11 (evening pre-dose) and 12 hours post-dose; Day 7: Pre-dose (evening), 1, 12 (Day 8), 16 (Day 8), 20 (Day 8) hours post-dose'}, {'measure': 'Concentration at the end of a dosing interval before the next dose administration (Ctrough)', 'timeFrame': 'Day 1: Pre-dose (morning); 30 minutes, 1, 4, 8, 11 (evening pre-dose) and 12 hours post-dose; Day 7: Pre-dose (evening), 1, 12 (Day 8), 16 (Day 8), 20 (Day 8) hours post-dose'}, {'measure': 'Area under the plasma concentration versus time curve from zero to 24 h post-dose (AUC0-24)', 'timeFrame': 'Day 1: Pre-dose (morning); 30 minutes, 1, 4, 8, 11 (evening pre-dose) and 12 hours post-dose; Day 7: Pre-dose (evening), 1, 12 (Day 8), 16 (Day 8), 20 (Day 8) hours post-dose'}, {'measure': 'Area under the plasma concentration versus time curve up to the last measurable concentration (AUClast)', 'timeFrame': 'Day 1: Pre-dose (morning); 30 minutes, 1, 4, 8, 11 (evening pre-dose) and 12 hours post-dose; Day 7: Pre-dose (evening), 1, 12 (Day 8), 16 (Day 8), 20 (Day 8) hours post-dose'}, {'measure': 'Apparent terminal half-life (T1/2)', 'timeFrame': 'Day 1: Pre-dose (morning); 30 minutes, 1, 4, 8, 11 (evening pre-dose) and 12 hours post-dose; Day 7: Pre-dose (evening), 1, 12 (Day 8), 16 (Day 8), 20 (Day 8) hours post-dose'}]}, 'conditionsModule': {'conditions': ['Glaucoma']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to assess the safety, tolerability, and IOP effects of RO5093151 following 7 days of topical ocular treatment in patients with primary open angle glaucoma or ocular hypertension.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Diagnosis of ocular hypertension (OHT) or primary open angle glaucoma (POAG) in at least one eye (qualifying eye) as determined by the Investigator at screening or based on a reliable and documented assessment done within the last 6 months prior to screening provided that no progression of visual field damage is expected\n* At baseline visit, intraocular pressure (IOP) \\>= 24 mmHg in the morning and \\>= 21 mmHg in the afternoon measurement in at least one eye (qualifying eye = study eye) and =\\< 34 mmHg at all time points in both eyes\n* Best corrected logMAR visual acuity score of 0.7 (20/100 Snellen) or better in each eye as measured by ETDRS visual acuity test at screening\n* Central corneal pachymetry measurement 420 to 620 micrometer in qualifying eye at screening\n* Cup-to-disk ratio =\\< 0.8 (both eyes) at screening\n* Anterior chamber angle is open and non-occludable as confirmed by the Investigator by gonioscopy examination at screening\n\nExclusion Criteria:\n\n* History of any clinically significant gastrointestinal, renal, hepatic, bronchopulmonary, neurological, psychiatric, cardio-vascular, endocrinological, hematological or allergic disease (multiple allergies, seasonal allergy is acceptable), metabolic disorder, cancer or cirrhosis\n* Uncontrolled hypertension (SBP \\>= 160 mmHg and/or DBP \\>= 100 mmHg) despite treatment at the time of screening confirmed by the average of \\>= 3 blood pressure measurements, properly measured with well-maintained equipment\n* Clinically significant abnormalities in laboratory test results at screening\n* Hypersensitivity to RO5093151 or any of the components of its formulation, or hypersensitivity to latanoprost or any of the components of its formulation (Part B only)\n* Donation of blood over 500 mL within three months prior to screening\n* Positive result on hepatitis B (HBV), hepatitis C (HCV), or HIV 1 and 2\n* Presence of narrow angle (=\\< grade 2 Shaffer gonioscopic classification) or complete or partial closure, as measured by gonioscopy or at risk for angle closure as assessed by the Investigator\n* Other forms of glaucoma than POAG or OHT in the study eye\n* Any abnormality preventing reliable applanation tonometry\n* Any clinically significant corneal scarring, haze or opacity\n* Patient uncooperativeness that restricts adequate examination of IOP, ocular fundus or anterior chamber\n* Evidence of clinically significant blepharitis, concurrent infectious/non-infectious conjunctivitis, keratitis or uveitis\n* History or signs of penetrating ocular trauma. Uneventful (uncomplicated) cataract surgery performed 3 months prior to screening is allowed\n* According to the Investigator's best judgment, risk of visual field or visual acuity worsening in either eye as a consequence of glaucoma progression or consequence of participation in the trial (i.e., during washout of ocular hypotensive medications or treatment with placebo) or any other ocular disease\n* Unable to safely stop ocular hypotension medications prior to randomization according to the required minimum washout periods\n* History of any ocular filtering surgical intervention, previous glaucoma intraocular surgery, or laser trabeculoplasty\n* History of refractive surgery (laser assisted in-situ keratomileusis, laser epithelial keratomileusis, photorefractive keratectomy, phototherapeutic keratectomy)\n* Any other intraocular surgery within 6 months of screening\n* Advanced age-related macular degeneration (wet or dry), vitreous hemorrhage, diabetic retinopathy or any progressive retinal or optic nerve disease from any cause other than glaucoma"}, 'identificationModule': {'nctId': 'NCT02622334', 'briefTitle': 'A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO5093151 in Patients With Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT).', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'A MULTIPLE-CENTER, INVESTIGATOR/SUBJECT MASKED, ADAPTIVE, MULTIPLE ASCENDING DOSE, RANDOMIZED, PLACEBO-CONTROLLED, PARALLEL STUDY TO INVESTIGATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF RO5093151 FOLLOWING 7 DAYS ADMINISTRATION IN PATIENTS WITH PRIMARY OPEN ANGLE GLAUCOMA OR OCULAR HYPERTENSION', 'orgStudyIdInfo': {'id': 'BP30002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part A', 'description': 'Participants will receive up to 3 multiple ascending dose levels with the starting dose of 0.1% RO5093151 (topical ocular instillation) and sequentially 0.5% and 1% RO5093151 doses or placebo (3:1, active:placebo) twice a day (BID) on Day 1 and once a day (QD) for 6 days.', 'interventionNames': ['Drug: Placebo', 'Drug: RO5093151']}, {'type': 'EXPERIMENTAL', 'label': 'Part B', 'description': 'Participants will receive highest feasible dose (HFD) or maximum tolerated dose (MTD) of RO5093151 from Part A or 0.005% latanoprost (topical ocular instillation) once daily for 7 days.', 'interventionNames': ['Drug: Latanoprost', 'Drug: RO5093151']}], 'interventions': [{'name': 'Latanoprost', 'type': 'DRUG', 'description': 'Latanoprost is a ophthalmic solution, available in dose strength as 0.005%.', 'armGroupLabels': ['Part B']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Matching placebo formulation will be administered in Part A.', 'armGroupLabels': ['Part A']}, {'name': 'RO5093151', 'type': 'DRUG', 'description': 'RO5093151 is a ophthalmic solution, available in dose strengths as 0.1%, 0.5% and 1%.', 'armGroupLabels': ['Part A', 'Part B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90701', 'city': 'Artesia', 'state': 'California', 'country': 'United States', 'facility': 'Sall Research Medical Center', 'geoPoint': {'lat': 33.86585, 'lon': -118.08312}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'Rocky Mountain Lions Eye Inst', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '30260', 'city': 'Morrow', 'state': 'Georgia', 'country': 'United States', 'facility': 'Eye Care Centers Management, Inc. (Clayton Eye Center)', 'geoPoint': {'lat': 33.58317, 'lon': -84.33937}}, {'zip': '10003', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'New York Eye and Ear Infirmary of Mt. Sinai; New York Glaucoma Research Institute', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '27262', 'city': 'High Point', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Cornerstone Eye Care, Div of Cornerstone Health Care', 'geoPoint': {'lat': 35.95569, 'lon': -80.00532}}, {'zip': '26506', 'city': 'Morgantown', 'state': 'West Virginia', 'country': 'United States', 'facility': 'West Virginia University Eye Institute', 'geoPoint': {'lat': 39.62953, 'lon': -79.9559}}, {'zip': '168751', 'city': 'Singapore', 'country': 'Singapore', 'facility': 'Singapore National Eye Centre; Glaucoma Department', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hoffmann-La Roche'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}