Ignite Creation Date:
2025-12-25 @ 12:43 AM
Ignite Modification Date:
2025-12-29 @ 7:11 AM
Study NCT ID:
NCT00800267
Status:
COMPLETED
Last Update Posted:
2021-02-18
First Post:
2008-11-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Glaucoma or Ocular Hypertension in Patients Within the United States
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009798', 'term': 'Ocular Hypertension'}, {'id': 'D005901', 'term': 'Glaucoma'}], 'ancestors': [{'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 418}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1997-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-03', 'completionDateStruct': {'date': '1999-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-17', 'studyFirstSubmitDate': '2008-11-03', 'studyFirstSubmitQcDate': '2008-12-01', 'lastUpdatePostDateStruct': {'date': '2021-02-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-12-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '1999-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The differences from baseline in diurnal IOP reduction after six months of treatment will be tested between the fixed combination and the monotherapy groups.', 'timeFrame': '6 months'}, {'measure': 'Primary objective: to demonstrate that the fixed combination of latanoprost and timolol has a better IOP-reducing effect than the individual monotherapies.', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'To examine, within treatment groups, the diurnal IOP reducing effect from baseline for all effect from baseline between the monotherapies latanoprost and timolol', 'timeFrame': '6 months'}, {'measure': 'To compare the diurnal IOP reducing effect from baseline between the monotherapies latanoprost and timolol at Week 26', 'timeFrame': '6 months'}, {'measure': 'To compared the number of treatment failures and patients withdrawn due to uncontrolled IOP from baseline to Week 26 between treatment groups', 'timeFrame': '6 months'}, {'measure': 'To describe the IOP development from baseline to Week 26 for all treatment groups', 'timeFrame': '6 months'}, {'measure': 'To compared the IOP reducing effect from baseline to Week 26 of the monotherapies with the IOP reducing effect from Week 26 to Week 52 of the fixed combination', 'timeFrame': '6 months'}, {'measure': 'To examine, within the fixed combination treatment group, the diurnal IOP reducing effect from baseline to Week 26 and Week 52', 'timeFrame': '6 months'}, {'measure': 'To follow the safety variables throughout the study periods.', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['glaucoma', 'ocular hypertension', 'Fixed combination latanoprost-timolol', 'latanoprost', 'timolol'], 'conditions': ['Ocular Hypertension', 'Glaucoma']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=96TIPG005&StudyName=A%20study%20of%20glaucoma%20or%20ocular%20hypertension%20in%20patients%20within%20the%20United%20States.', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'Safety and efficacy study comparing between fixed combination latanoprost-timolol and its component parts.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Unilateral or bilateral primary open angle glaucoma, capsular glaucoma, pigmentary glaucoma or ocular hypertension.\n* Patients currently on IOP reducing therapy: IOP greater than or equal to 25mmHg (Ltwo IOP determinations at pre-study separated by at least one hour) OR Patients without IOP reducing therapy: IOP greater than or equal to 30mmHg (two IOP determinations at pre-study separated by at least one hour).\n\nExclusion Criteria:\n\n* History of acute angle closure or closed/barely open anterior chamber angle.\n* Current use of contact lenses.\n* Ocular surgery or argon laser trabeculoplasty (ALT) within three months prior to pre-study visit.\n* Ocular inflammation/infection occurring within three months prior to pre-study visit.\n* Hypersensitivity to benzalkonium chloride or to any other component of the study drug solutions.\n* Other abnormal ocular condition or symptom preventing the patient from entering the study, according to the investigator's judgement.\n* Patients with conditions in which treatment with B-blocking agents are contraindicated: cardiac failure, sinus bradycardia, second and third degree atrio-ventricular block.\n* Patients with conditions in which treatment with B-blocking agents are contraindicated: bronchial asthma, history of bronchial asthma or chronic obstructive pulmonary disease.\n* Inability to adhere to treatment/visit plan.\n* Have participated in any other clinical study within one month prior to pre-study visit."}, 'identificationModule': {'nctId': 'NCT00800267', 'briefTitle': 'A Study of Glaucoma or Ocular Hypertension in Patients Within the United States', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A 6-month, Randomized, Double-masked Comparison of Fixed Combination of Latanoprost and Timolol With the Individual Components, Continuing Into a 6-month Open Label Safety Study of Fixed Combination in Patients With Glaucoma or Ocular Hypertension. A Multicenter Study in the United States', 'orgStudyIdInfo': {'id': '96TIPG005'}, 'secondaryIdInfos': [{'id': 'A6641006'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fixed combination of latanoprost 0.005% and timolol 0.5%', 'interventionNames': ['Drug: fixed combination latanoprost-timolol']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'latanoprost 0.005%', 'interventionNames': ['Drug: latanoprost 0.005%']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Timolol - 0.5%', 'interventionNames': ['Drug: timolol 0.5%']}], 'interventions': [{'name': 'latanoprost 0.005%', 'type': 'DRUG', 'description': 'placebo in the morning and latanoprost .005% in the evening', 'armGroupLabels': ['latanoprost 0.005%']}, {'name': 'fixed combination latanoprost-timolol', 'type': 'DRUG', 'description': 'one drop in the morning and placebo in the evening', 'armGroupLabels': ['Fixed combination of latanoprost 0.005% and timolol 0.5%']}, {'name': 'timolol 0.5%', 'type': 'DRUG', 'description': 'one drop in the morning and evening', 'armGroupLabels': ['Timolol - 0.5%']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92801', 'city': 'Anaheim', 'state': 'California', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}, {'zip': '92807', 'city': 'Anaheim', 'state': 'California', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}, {'zip': '95819', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '95823', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '94115', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 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