Ignite Creation Date:
2025-12-24 @ 12:13 PM
Ignite Modification Date:
2025-12-27 @ 10:37 PM
Study NCT ID:
NCT04098861
Status:
UNKNOWN
Last Update Posted:
2019-09-23
First Post:
2019-09-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Latanoprost/Timolol for Primary Open Angle Glaucoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005902', 'term': 'Glaucoma, Open-Angle'}], 'ancestors': [{'id': 'D005901', 'term': 'Glaucoma'}, {'id': 'D009798', 'term': 'Ocular Hypertension'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077338', 'term': 'Latanoprost'}, {'id': 'D013999', 'term': 'Timolol'}], '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'}, {'id': 'D011412', 'term': 'Propanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D020005', 'term': 'Propanols'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D013830', 'term': 'Thiadiazoles'}, {'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D009025', 'term': 'Morpholines'}, {'id': 'D010078', 'term': 'Oxazines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'A single-center, randomized open-labeled, prospective, crossover study.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-01-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2020-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-09-19', 'studyFirstSubmitDate': '2019-09-19', 'studyFirstSubmitQcDate': '2019-09-19', 'lastUpdatePostDateStruct': {'date': '2019-09-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-09-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy: Intraocular pressure reduction', 'timeFrame': '4 weeks', 'description': 'IOP reduction with LTFC given once and twice daily in POAG patients'}], 'secondaryOutcomes': [{'measure': 'Safety: Side effects', 'timeFrame': '4 weeks', 'description': 'Side effects of LTFC given twice daily in POAG patients'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Primary Open Angle Glaucoma']}, 'descriptionModule': {'briefSummary': 'Intraocular pressure (IOP) is the most important modifiable risk factor to prevent and delay progression of glaucoma. IOP reduction has been proven to delay the onset and progression of glaucoma, and uncontrolled IOP is constantly associated with progression of visual field loss.\n\nMedical therapy is the first line in IOP reduction for Primary Open Angle Glaucoma (POAG). It is a known fact that glaucoma patients often require addition of a second antiglaucoma medications when disease progresses or tachyphylaxis occurs. It was reported that more than 50% of patients require 2 or more medications to achieve optimum IOP control.\n\nNevertheless, compliance and adherence are often impaired with multiple-drug therapy. Combining two ocular hypotensive agents in one bottle may help patients adhere to therapeutic regimen by reducing the number of medications used and the total number of doses administered.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'gender identity', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age 18 and above\n2. Able to provide informed consent\n3. Diagnosed as having unilateral or bilateral, mild to moderate POAG\n4. The POAG treated with only two antiglaucoma\n\nExclusion Criteria:\n\n1. Advanced POAG\n2. Patient with contraindication for topical use of a-blocker and prostaglandin analogue\n3. Patient with contraindication for systemic use of a-blocker\n4. Patient on systemic use of a-blocker such as metoprolol, propranolol, atenolol\n5. History of orbital or ocular trauma.\n6. History of cataract surgery less than 6 months.\n7. History of previous ocular surgery; e.g. vitreoretinal surgery, corneal transplantation or glaucoma surgery\n8. Any active eye infections or corneal ulceration.\n9. Patient with ocular surface disease\n10. Other ocular disease that might interfere with IOP measurements or result\n11. Precious eye i.e patient with only one good eye\n12. Contact lens is not allowed within 1 week before the start of study and during the study'}, 'identificationModule': {'nctId': 'NCT04098861', 'briefTitle': 'Efficacy and Safety of Latanoprost/Timolol for Primary Open Angle Glaucoma', 'organization': {'class': 'OTHER', 'fullName': 'Universiti Kebangsaan Malaysia Medical Centre'}, 'officialTitle': 'Efficacy and Safety of Latanoprost/Timolol Fixed Combination Dosed Twice Daily Compared to Once Daily in Patients With Primary Open Angle Glaucoma', 'orgStudyIdInfo': {'id': 'FF-2019-058'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'once daily group', 'description': 'Latanoprost/Timolol Fixed Combination (LTFC) will be administered once daily for 4 weeks. The IOP will be determined on Day 14 and 28. The following examinations will be performed: evaluation of conjunctiva hyperemia, anterior chamber reaction, applanation tonometry, measurement of blood pressure and heart rate.\n\nFor once daily dosing, the eye drops will be instilled at 8am every morning. The IOP will be taken at 9am-12pm on study day.', 'interventionNames': ['Drug: Latanoprost/Timolol']}, {'type': 'EXPERIMENTAL', 'label': 'twice daily group', 'description': 'Latanoprost/Timolol Fixed Combination (LTFC) will be administered twice daily for 4 weeks. The IOP will be determined on Day 14 and 28. The following examinations will be performed: evaluation of conjunctiva hyperemia, anterior chamber reaction, applanation tonometry, measurement of blood pressure and heart rate.\n\nFor twice dosing, the eye drops will be instilled at 8am and 8pm. The IOP will be taken at 9am-12pm on study day.', 'interventionNames': ['Drug: Latanoprost/Timolol']}], 'interventions': [{'name': 'Latanoprost/Timolol', 'type': 'DRUG', 'description': 'Latanoprost/Timolol Fixed Combination', 'armGroupLabels': ['once daily group', 'twice daily group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '56000', 'city': 'Cheras', 'state': 'Kuala Lumpur', 'status': 'RECRUITING', 'country': 'Malaysia', 'contacts': [{'name': 'Mohd Hairul', 'role': 'CONTACT', 'email': 'hairulnizam@ppukm.ukm.edu.my', 'phone': '192347377'}], 'facility': 'Universiti Kebangsaan Malaysia Medical Centre'}], 'centralContacts': [{'name': 'Mohd Hairul Nizam Harun, MSc', 'role': 'CONTACT', 'email': 'hairulnizam@ppukm.ukm.edu.my', 'phone': '+0391457447'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universiti Kebangsaan Malaysia Medical Centre', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Norshamsiah Md Din', 'investigatorAffiliation': 'Universiti Kebangsaan Malaysia Medical Centre'}}}}