Ignite Creation Date:
2025-12-24 @ 2:06 PM
Ignite Modification Date:
2026-02-20 @ 10:56 PM
Study NCT ID:
NCT03274895
Status:
COMPLETED
Last Update Posted:
2023-08-22
First Post:
2017-09-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Polihexanide (PHMB) Eye Drops in Patients Affected by Acanthamoeba Keratitis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015823', 'term': 'Acanthamoeba Keratitis'}], 'ancestors': [{'id': 'D015822', 'term': 'Eye Infections, Parasitic'}, {'id': 'D010272', 'term': 'Parasitic Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D000562', 'term': 'Amebiasis'}, {'id': 'D011528', 'term': 'Protozoan Infections'}, {'id': 'D007634', 'term': 'Keratitis'}, {'id': 'D003316', 'term': 'Corneal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D015817', 'term': 'Eye Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C031233', 'term': 'polihexanide'}, {'id': 'C053597', 'term': 'dibrompropamidine'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jelle.kleijn@sifigroup.com', 'phone': '+31615643708', 'title': 'Dr. Jelle Kleijn', 'organization': 'SIFI SpA'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '1 year', 'eventGroups': [{'id': 'EG000', 'title': 'PHMB 0.08% Plus Placebo', 'description': 'polihexanide (PHMB) 0.08% and placebo were administered in the affected eye until clinical resolution for a maximum of 12 months', 'otherNumAtRisk': 69, 'deathsNumAtRisk': 69, 'otherNumAffected': 31, 'seriousNumAtRisk': 69, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'PHMB 0.02% Plus Propamidine 0.1%', 'description': 'polihexanide (PHMB) 0.02% and propamidine 0.1% were administered in the affected eye until clinical resolution for a maximum of 12 months', 'otherNumAtRisk': 65, 'deathsNumAtRisk': 65, 'otherNumAffected': 29, 'seriousNumAtRisk': 65, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'eye pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 11, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'ocular hyperemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 9, 'numAffected': 7}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'lacrimation increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'conjunctival hyperemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'eye irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'photophobia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'eye inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 3, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'corneal epithelium defect', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'corneal infiltrates', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'eye pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'eye discharge', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'eye swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'keratitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'ocular discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Clinical Resolution Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PHMB 0.08% Plus Placebo', 'description': 'Polihexanide (PHMB) 0.08% and placebo were administered in the affected eye until clinical resolution for a maximum of 12 months'}, {'id': 'OG001', 'title': 'PHMB 0.02% Plus Propamidine 0.1%', 'description': 'polihexanide (PHMB) 0.02% and propamidine 0.1% were administered in the affected eye until clinical resolution for a maximum of 12 months'}], 'classes': [{'categories': [{'measurements': [{'value': '84.8', 'groupId': 'OG000', 'lowerLimit': '73.9', 'upperLimit': '92.5'}, {'value': '88.5', 'groupId': 'OG001', 'lowerLimit': '77.8', 'upperLimit': '95.3'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'difference in proportion of resolution r', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.036', 'ciLowerLimit': '-0.154', 'ciUpperLimit': '0.081', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Non-inferiority margin= 0.20'}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'description': 'Percentage of patients cured 30 days after discontinuing all study therapies, within 12 months of randomization', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat'}, {'type': 'SECONDARY', 'title': 'Time to Cure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PHMB 0.08% Plus Placebo', 'description': 'Polihexanide (PHMB) 0.08% and placebo were administered in the affected eye until clinical resolution for a maximum of 12 months'}, {'id': 'OG001', 'title': 'PHMB 0.02% Plus Propamidine 0.1%', 'description': 'Polihexanide (PHMB) 0.02% and propamidine 0.1% were administered in the affected eye until clinical resolution for a maximum of 12 months'}], 'classes': [{'categories': [{'measurements': [{'value': '140', 'groupId': 'OG000', 'lowerLimit': '117', 'upperLimit': '150'}, {'value': '114', 'groupId': 'OG001', 'lowerLimit': '91', 'upperLimit': '127'}]}]}], 'analyses': [{'pValue': '0.042', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'maximum 12 months', 'description': 'Time needed to reach a clinical resolution', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat'}, {'type': 'SECONDARY', 'title': 'Visual Acuity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PHMB 0.08% Plus Placebo', 'description': '16 drops of each solution in a day for 5 days,8 drops each in a day for 7 days,6 drops each in a day for 7 days and 4 drops each in a day up to clinical resolution'}, {'id': 'OG001', 'title': 'PHMB 0.02% Plus Propamidine 0.1%', 'description': '16 drops of each solution in a day for 5 days,8 drops each in a day for 7 days,6 drops each in a day for 7 days and 4 drops each in a day up to clinical resolution'}], 'classes': [{'categories': [{'measurements': [{'value': '0.000', 'groupId': 'OG000', 'lowerLimit': '0.000', 'upperLimit': '0.250'}, {'value': '0.000', 'groupId': 'OG001', 'lowerLimit': '-0.080', 'upperLimit': '0.150'}]}]}], 'analyses': [{'pValue': '0.577', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'maximum 12 months', 'description': 'Final visual acuity (best corrected)', 'unitOfMeasure': 'LogMAR', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'PHMB 0.08% Plus Placebo', 'description': '16 drops of each solution in a day for 5 days,8 drops each in a day for 7 days,6 drops each in a day for 7 days and 4 drops each in a day up to clinical resolution'}, {'id': 'FG001', 'title': 'PHMB 0.02% Plus Propamidine 0.1%', 'description': '16 drops of each solution in a day for 5 days,8 drops each in a day for 7 days,6 drops each in a day for 7 days and 4 drops each in a day up to clinical resolution'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': '3 patients had no confirmation of diagnosis and therefore the overall number of participants analyzed is 66', 'groupId': 'FG000', 'numSubjects': '69'}, {'comment': '4 patients had no confimation of diagnosis and therefore the overall number of participants analyzed is 61', 'groupId': 'FG001', 'numSubjects': '65'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '56'}, {'groupId': 'FG001', 'numSubjects': '54'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '11'}]}], 'dropWithdraws': [{'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Diagnosis not confirmed', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}]}]}], 'recruitmentDetails': 'Participants were recruited from August 2017 and March 2021. Of the 135 enrolled participants 134 were randomized to treatment'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '134', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'PHMB 0.08% Plus Placebo', 'description': 'Polihexanide (PHMB) 0.08% and placebo were administered in the affected eye until clinical resolution for a maximum of 12 months'}, {'id': 'BG001', 'title': 'PHMB 0.02% Plus Propamidine 0.1%', 'description': 'Polihexanide (PHMB) 0.02% and propamidine 0.1% were administered in the affected eye until clinical resolution for a maximum of 12 months'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '134', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '33', 'groupId': 'BG000', 'lowerLimit': '25', 'upperLimit': '43'}, {'value': '36', 'groupId': 'BG001', 'lowerLimit': '26', 'upperLimit': '49'}, {'value': '35', 'groupId': 'BG002', 'lowerLimit': '25', 'upperLimit': '46'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '134', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '78', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '56', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Visual acuity (best corrected)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '134', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0.350', 'groupId': 'BG000', 'lowerLimit': '0.150', 'upperLimit': '0.70'}, {'value': '0.260', 'groupId': 'BG001', 'lowerLimit': '0.100', 'upperLimit': '0.480'}, {'value': '0.300', 'groupId': 'BG002', 'lowerLimit': '0.150', 'upperLimit': '0.700'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'LogMAR', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Culture positivity for Acanthamoeba', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '134', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'PCR positivity for Acanthamoeba', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '134', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-10-08', 'size': 3392779, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-09-12T10:01', 'hasProtocol': True}, {'date': '2021-07-01', 'size': 2372939, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-09-12T10:03', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 135}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-08-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2022-03-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-02', 'studyFirstSubmitDate': '2017-09-05', 'resultsFirstSubmitDate': '2022-09-12', 'studyFirstSubmitQcDate': '2017-09-05', 'lastUpdatePostDateStruct': {'date': '2023-08-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-08-01', 'studyFirstPostDateStruct': {'date': '2017-09-07', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-08-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical Resolution Rate', 'timeFrame': '12 months', 'description': 'Percentage of patients cured 30 days after discontinuing all study therapies, within 12 months of randomization'}], 'secondaryOutcomes': [{'measure': 'Time to Cure', 'timeFrame': 'maximum 12 months', 'description': 'Time needed to reach a clinical resolution'}, {'measure': 'Visual Acuity', 'timeFrame': 'maximum 12 months', 'description': 'Final visual acuity (best corrected)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['polihexanide', 'propamidine', 'confocal microscopy'], 'conditions': ['Acanthamoeba Keratitis']}, 'referencesModule': {'references': [{'pmid': '31401556', 'type': 'BACKGROUND', 'citation': 'Papa V, Rama P, Radford C, Minassian DC, Dart JKG. Acanthamoeba keratitis therapy: time to cure and visual outcome analysis for different antiamoebic therapies in 227 cases. Br J Ophthalmol. 2020 Apr;104(4):575-581. doi: 10.1136/bjophthalmol-2019-314485. Epub 2019 Aug 10.'}, {'pmid': '33239413', 'type': 'BACKGROUND', 'citation': 'Papa V, van der Meulen I, Rottey S, Sallet G, Overweel J, Asero N, Minassian DC, Dart JKG. Safety and tolerability of topical polyhexamethylene biguanide: a randomised clinical trial in healthy adult volunteers. Br J Ophthalmol. 2022 Feb;106(2):190-196. doi: 10.1136/bjophthalmol-2020-317848. Epub 2020 Nov 25.'}, {'pmid': '37802392', 'type': 'DERIVED', 'citation': 'Dart JKG, Papa V, Rama P, Knutsson KA, Ahmad S, Hau S, Sanchez S, Franch A, Birattari F, Leon P, Fasolo A, Kominek EM, Jadczyk-Sorek K, Carley F, Hossain P, Minassian DC. The Orphan Drug for Acanthamoeba Keratitis (ODAK) Trial: PHMB 0.08% (Polihexanide) and Placebo versus PHMB 0.02% and Propamidine 0.1. Ophthalmology. 2024 Mar;131(3):277-287. doi: 10.1016/j.ophtha.2023.09.031. Epub 2023 Oct 5.'}]}, 'descriptionModule': {'briefSummary': 'Prospective randomized study to evaluate the efficacy, safety and tolerability of 0.08% polihexanide (PHMB) eye drops in patients affected by acanthamoeba keratitis.\n\n130 subjects were assigned to one of the following 2 treatment groups: Group 1: 0.08% polihexanide (PHMB) + placebo Group 2: 0.02% polihexanide (PHMB) + 0.1% propamidine', 'detailedDescription': 'This was a randomized, assessor-masked, active-controlled, multiple center, parallel-group phase 3 study to evaluate the efficacy, safety and tolerability of 0.08% polihexanide (PHMB) ophthalmic solution compared to the conventional 0.02% polihexanide (PHMB) + 0.1% propamidine in patients affected by acanthamoeba keratitis.\n\nThe study was designed as a superiority study with the possibility to test for non-inferiority if the superiority hypothesis was not met (CPMP/EWP/482/99).The study consisted of an eligibility screening visit, a treatment period including monthly follow-up visits until a clinical resolution was obtained (within a maximum of 1 year), followed by 2 post-treatment off-therapy visits (30 and 90 days after treatment discontinuation). 130 subjects with confirmed diagnosis of acanthamoeba keratitis (clinical signs plus positive confocal microscopy findings) were assigned to one of the following treatment groups in a ratio of 1:1.\n\nGroup 1: 0.08% PHMB + placebo Group 2: 0.02% PHMB + 0.1% propamidine'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '13 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. willing to give informed consent\n2. man or woman of any race and ≥12 years of age\n3. able to understand and willing to comply with study procedures, restrictions and requirements\n4. Clinical findings consistent with Acanthamoeba keratitis\n5. Confocal microscopy findings consistent with Acanthamoeba keratitis\n6. The following previous treatments for Acanthamoeba keratitis are eligible: antibiotics, antiviral and antifungal drugs, antiinflammatory drugs\n7. Females of childbearing potential will be included if they are either sexually inactive or using one highly effective contraceptive\n8. Females of childbearing potential agree to remain sexually inactive or to keep the same birth control method for at least 28 days following the last study drug dose\n9. A female of non-childbearing potential must have undergone one sterilization procedures at least 6 months prior to the first study drug dose\n10. A non-vasectomized male subject agrees to use a condom with spermicide or abstain from sexual intercourse during the study until 90 days beyond the last dose of study drug and the female partner agrees to comply with inclusion 7 or 8. For a vasectomized male who has had his vasectomy 6 months or more prior to study start, it is required that they use a condom during sexual intercourse. A male who has been vasectomized less than 6 months prior to study start must follow the same restrictions as a non-vasectomized male.\n11. If male, they must agree not to donate sperm from the first study drug dose until 90 days after dosing\n\nExclusion Criteria:\n\n1. Subject with documented history and/or clinical signs of concomitant presence of an ocular infection caused by viruses (herpes simplex virus \\[HSV\\]) or fungi.\n2. Subject treated with drugs having effects on Acanthamoeba cysts prior to study entry, including biguanides (PHMB, chlorhexidine) and diamidines (propamidine, hexamidine).\n3. Subjects requiring systemic immunosuppression for Acanthamoeba associated scleritis.\n4. Subjects requiring urgent surgical intervention for advanced Acanthamoeba keratitis in either eye (e.g., for advanced corneal thinning/melting etc.).\n5. Subject with known or suspected allergy to biguanides, diamidines or intolerance to any other ingredient of the investigational treatments.\n6. Subject affected by immunodeficiency diseases or taking systemic immunosuppressive therapy.\n7. Subject with a major systemic disease or other illness that would, in the opinion of the investigator, compromise subject's safety or interfere with the collection or interpretation of study results.\n8. If female, pregnancy, planned pregnancy, or breast-feeding\n9. Subject is participating in another interventional clinical study with an experimental or unapproved/unlicensed therapy or has participated in another interventional clinical study within 4 weeks prior to this study."}, 'identificationModule': {'nctId': 'NCT03274895', 'briefTitle': 'Polihexanide (PHMB) Eye Drops in Patients Affected by Acanthamoeba Keratitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'SIFI SpA'}, 'officialTitle': 'Randomized, Active-Controlled, Phase 3 Study to Evaluate Efficacy, Safety and Tolerability of 0.08% PHMB Ophthalmic Solution in Comparison With 0.02% PHMB + 0.1% Propamidine Combination Therapy in Subjects Affected by Acanthamoeba Keratitis', 'orgStudyIdInfo': {'id': '043/SI'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PHMB 0.08% plus placebo', 'description': 'polihexanide (PHMB) 0.08% and placebo were administered in the affected eye until clinical resolution for a maximum of 12 months', 'interventionNames': ['Drug: PHMB 0.08%', 'Drug: placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'PHMB 0.02% plus propamidine 0.1%', 'description': 'polihexanide (PHMB) 0.02% and propamidine 0.1% were administered in the affected eye until clinical resolution for a maximum of 12 months', 'interventionNames': ['Drug: Propamidine 0.1%', 'Drug: PHMB 0.02%']}], 'interventions': [{'name': 'PHMB 0.08%', 'type': 'DRUG', 'otherNames': ['Polihexanide 0.8 mg/ml'], 'description': '16 drops in a day in the affected eye for 5 days followed by 8 drops in a day for 7 days,6 drops in a day for 7 days and 4 drops in a day up to clinical resolution', 'armGroupLabels': ['PHMB 0.08% plus placebo']}, {'name': 'Propamidine 0.1%', 'type': 'DRUG', 'otherNames': ['Brolene eye drops'], 'description': '16 drops in a day in the affected eye for 5 days followed by 8 drops in a day for 7 days,6 drops in a day for 7 days and 4 drops in a day up to clinical resolution', 'armGroupLabels': ['PHMB 0.02% plus propamidine 0.1%']}, {'name': 'placebo', 'type': 'DRUG', 'otherNames': ['Brolene vehicle'], 'description': '16 drops in a day in the affected eye for 5 days followed by 8 drops in a day for 7 days,6 drops in a day for 7 days and 4 drops in a day up to clinical resolution', 'armGroupLabels': ['PHMB 0.08% plus placebo']}, {'name': 'PHMB 0.02%', 'type': 'DRUG', 'otherNames': ['Polihexanide 0.2 mg/ml'], 'description': '16 drops in a day in the affected eye for 5 days followed by 8 drops in a day for 7 days,6 drops in a day for 7 days and 4 drops in a day up to clinical resolution', 'armGroupLabels': ['PHMB 0.02% plus propamidine 0.1%']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Milan', 'country': 'Italy', 'facility': 'San Raffaele Hospital', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'city': 'Venice', 'country': 'Italy', 'facility': 'San Giovanni and Paolo Hospital', 'geoPoint': {'lat': 45.43713, 'lon': 12.33265}}, {'city': 'Katowice', 'country': 'Poland', 'facility': 'University Clinical Center Medical University of Silesia', 'geoPoint': {'lat': 50.2597, 'lon': 19.02173}}, {'city': 'London', 'country': 'United Kingdom', 'facility': 'Moorfields Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'city': 'Manchester', 'country': 'United Kingdom', 'facility': 'Manchester Royal Eye Hospital', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}, {'city': 'Southampton', 'country': 'United Kingdom', 'facility': 'University Hospital Southampton', 'geoPoint': {'lat': 50.90395, 'lon': -1.40428}}], 'overallOfficials': [{'name': 'John Dart, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Moorfield's Hospital London"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'SIFI SpA', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}