Ignite Creation Date:
2025-12-25 @ 3:38 AM
Ignite Modification Date:
2026-03-03 @ 4:07 PM
Study NCT ID:
NCT02975102
Status:
COMPLETED
Last Update Posted:
2024-06-24
First Post:
2016-11-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Evaluate the Performance and Safety of CBL-101 Versus Vismed® Multi Eye Drops in the Management of Dry Eye
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015352', 'term': 'Dry Eye Syndromes'}], 'ancestors': [{'id': 'D007766', 'term': 'Lacrimal Apparatus Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'natasa.orlic-pleyer@bausch.com', 'phone': '+49 30 330 93', 'title': 'Associate Director, Global Clinical Operations', 'phoneExt': '318', 'organization': 'Bausch + Lomb'}, 'certainAgreement': {'otherDetails': 'Sponsor have at least 60 days to review any publication or presentation. The first release of results will involve all sites in this multicenter study.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'The participants were not masked to treatment as the compared products were provided in their original bottles to maintain their aseptic conditions but all the bottles were relabelled with no trade name. Labels and outer packaging were identical except for randomization number. Participants received sealed boxes and returned sealed boxes with instructions to keep the investigator masked.'}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected during the whole treatment period from the first instillation until the last study visit (90 ± 10 days).', 'description': 'Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the investigational medical device. Adverse event reports were elicited from the participants or resulted from the assessments at each study visit and recorded.', 'eventGroups': [{'id': 'EG000', 'title': 'CBL-101 Eye Drops', 'description': 'Participants received CBL-101 Eye Drops, 3 to 6 times daily for 3 months in both eyes.\n\nCBL-101 Eye Drops: CE-marked medical device with 0.15% sodium hyaluronate and 0.5% polyethylene glycol (PEG)', 'otherNumAtRisk': 45, 'deathsNumAtRisk': 45, 'otherNumAffected': 2, 'seriousNumAtRisk': 45, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Vismed® Multi Eye Drops', 'description': 'Participants received Vismed® Multi Eye Drops, 3 to 6 times daily for 3 months in both eyes.\n\nVismed® Multi: CE-marked medical device with 0.18% sodium hyaluronate', 'otherNumAtRisk': 38, 'deathsNumAtRisk': 38, 'otherNumAffected': 1, 'seriousNumAtRisk': 38, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Eye irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '4'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Ocular Surface Fluorescein Staining Score at Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CBL-101 Eye Drops', 'description': 'Participants received CBL-101 Eye Drops, 3 to 6 times daily for 3 months in both eyes.\n\nCBL-101 Eye Drops: CE-marked medical device with 0.15% sodium hyaluronate and 0.5% polyethylene glycol (PEG)'}, {'id': 'OG001', 'title': 'Vismed® Multi Eye Drops', 'description': 'Participants received Vismed® Multi Eye Drops, 3 to 6 times daily for 3 months in both eyes.\n\nVismed® Multi: CE-marked medical device with 0.18% sodium hyaluronate'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.9', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '-2.4', 'spread': '0.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.4', 'ciLowerLimit': '-1.2', 'ciUpperLimit': '0.3', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.4', 'estimateComment': 'Treatment difference : CBL-101 - Vismed Multi', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'A sample size of 33 evaluable patients per treatment group was calculated to provide at least 90% power to demonstrate non-inferiority of CBL-101 to Vismed Multi. Assumptions included a non-inferiority margin of 2 grades and a standard deviation of 2.5'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (Day 0), Visit 4 (Day 28)', 'description': 'Mean change from baseline (CFB) in the study eye in Ocular Surface Fluorescein Staining (OSFS) scored according to the Oxford Scheme.\n\nThe Oxford Scheme is a validated scale consisting of a series of panels labelled A to E in order of increasing severity. Grade 0 corresponds to panel A increasing to Grade 5 corresponding to more than Panel E, with punctate dots representing staining. The 3 regions, cornea, nasal and temporal bulbar conjunctiva are graded separately from 0 to 5, with the OSFS score ranging from 0 (best outcome) to 15 (worst outcome). The OSFS is the sum score of the 3 subscores (cornea, nasal and temporal regions).\n\nThe study eye was the eligible eye with the highest OSFS score at baseline, which needed to be ≥4 and ≤9 on the 15-grade Oxford Scheme. If both eyes were eligible and had the same OSFS score, the study eye was the right eye.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed as planned on the Per-protocol population (78 participants) . The Per-protocol population consisted of all randomized participants with at least one instillation and one post-baseline assessment without any major protocol deviation (defined as impacting the primary endpoint)'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Ocular Surface Fluorescein Staining Score at Day 7 (Visit 3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CBL-101 Eye Drops', 'description': 'Participants received CBL-101 Eye Drops, 3 to 6 times daily for 3 months in both eyes.\n\nCBL-101 Eye Drops: CE-marked medical device with 0.15% sodium hyaluronate and 0.5% polyethylene glycol (PEG)'}, {'id': 'OG001', 'title': 'Vismed® Multi Eye Drops', 'description': 'Participants received Vismed® Multi Eye Drops, 3 to 6 times daily for 3 months in both eyes.\n\nVismed® Multi: CE-marked medical device with 0.18% sodium hyaluronate'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.7', 'spread': '0.2', 'groupId': 'OG000'}, {'value': '-1.4', 'spread': '0.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '> 0.05', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Significance level of 0.05', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjustment for baseline'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (Day 0), Visit 3 (Day 7)', 'description': 'Mean change from baseline (CFB) in the study eye in Ocular Surface Fluorescein Staining (OSFS) scored according to the Oxford Scheme.\n\nThe Oxford Scheme is a validated scale consisting of a series of panels labelled A to E in order of increasing severity. Grade 0 corresponds to panel A increasing to Grade 5 corresponding to more than Panel E, with punctate dots representing staining. The 3 regions, cornea, nasal and temporal bulbar conjunctiva are graded separately from 0 to 5, with the OSFS score ranging from 0 (best outcome) to 15 (worst outcome). The OSFS is the sum score of the 3 subscores (cornea, nasal and temporal regions).\n\nThe study eye was the eligible eye with the highest OSFS score at baseline, which needed to be ≥4 and ≤9 on the 15-grade Oxford Scheme. If both eyes were eligible and had the same OSFS score, the study eye was the right eye.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the Per-protocol population as planned. Two participants of the per-protocol population, one in each group did not have the Day 7 visit.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Ocular Surface Fluorescein Staining Score at Day 90 (Visit 5)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CBL-101 Eye Drops', 'description': 'Participants received CBL-101 Eye Drops, 3 to 6 times daily for 3 months in both eyes.\n\nCBL-101 Eye Drops: CE-marked medical device with 0.15% sodium hyaluronate and 0.5% polyethylene glycol (PEG)'}, {'id': 'OG001', 'title': 'Vismed® Multi Eye Drops', 'description': 'Participants received Vismed® Multi Eye Drops, 3 to 6 times daily for 3 months in both eyes.\n\nVismed® Multi: CE-marked medical device with 0.18% sodium hyaluronate'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.0', 'spread': '0.2', 'groupId': 'OG000'}, {'value': '-2.6', 'spread': '0.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0002', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Significance level of 0.05', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjustment for baseline'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (Day 0), Visit 5 (Day 90)', 'description': 'Mean change from baseline (CFB) in the study eye in Ocular Surface Fluorescein Staining (OSFS) scored according to the Oxford Scheme.\n\nThe Oxford Scheme is a validated scale consisting of a series of panels labelled A to E in order of increasing severity. Grade 0 corresponds to panel A increasing to Grade 5 corresponding to more than Panel E, with punctate dots representing staining. The 3 regions, cornea, nasal and temporal bulbar conjunctiva are graded separately from 0 to 5, with the OSFS score ranging from 0 (best outcome) to 15 (worst outcome). The OSFS is the sum score of the 3 subscores (cornea, nasal and temporal regions).\n\nThe study eye was the eligible eye with the highest OSFS score at baseline, which needed to be ≥4 and ≤9 on the 15-grade Oxford Scheme. If both eyes were eligible and had the same OSFS score, the study eye was the right eye.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Two participants of the per-protocol population, one in each group withdrew before the Day 90 visit.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Corneal Fluorescein Staining Score at Day 7 (Visit 3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CBL-101 Eye Drops', 'description': 'Participants received CBL-101 Eye Drops, 3 to 6 times daily for 3 months in both eyes.\n\nCBL-101 Eye Drops: CE-marked medical device with 0.15% sodium hyaluronate and 0.5% polyethylene glycol (PEG)'}, {'id': 'OG001', 'title': 'Vismed® Multi Eye Drops', 'description': 'Participants received Vismed® Multi Eye Drops, 3 to 6 times daily for 3 months in both eyes.\n\nVismed® Multi: CE-marked medical device with 0.18% sodium hyaluronate'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.5', 'spread': '0.1', 'groupId': 'OG000'}, {'value': '-0.4', 'spread': '0.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '> 0.05', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Significance level of 0.05', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjustment for baseline'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (Day 0), Visit 3 (Day 7)', 'description': 'Mean change from baseline (CFB) in the study eye in Corneal Fluorescein Staining scored according to the Oxford Scheme.\n\nThe Oxford Scheme is a validated scale consisting of a series of panels labelled A to E in order of increasing severity. Grade 0 corresponds to panel A increasing to Grade 5 corresponding to more than Panel E, with punctate dots representing staining. The Corneal region is graded separately from 0 (best outcome) to 5 (worst outcome).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the Per-protocol population as planned. Two participants of the per-protocol population, one in each group did not have the Day 7 visit.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Corneal Fluorescein Staining Score at Day 28 (Visit 4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CBL-101 Eye Drops', 'description': 'Participants received CBL-101 Eye Drops, 3 to 6 times daily for 3 months in both eyes.\n\nCBL-101 Eye Drops: CE-marked medical device with 0.15% sodium hyaluronate and 0.5% polyethylene glycol (PEG)'}, {'id': 'OG001', 'title': 'Vismed® Multi Eye Drops', 'description': 'Participants received Vismed® Multi Eye Drops, 3 to 6 times daily for 3 months in both eyes.\n\nVismed® Multi: CE-marked medical device with 0.18% sodium hyaluronate'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.9', 'spread': '0.1', 'groupId': 'OG000'}, {'value': '-0.8', 'spread': '0.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '> 0.05', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Significance level of 0.05', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjustment for baseline'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (Day 0), Visit 4 (Day 28)', 'description': 'Mean change from baseline (CFB) in the study eye in Corneal Fluorescein Staining scored according to the Oxford Scheme.\n\nThe Oxford Scheme is a validated scale consisting of a series of panels labelled A to E in order of increasing severity. Grade 0 corresponds to panel A increasing to Grade 5 corresponding to more than Panel E, with punctate dots representing staining. The Corneal region is graded separately from 0 (best outcome) to 5 (worst outcome).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed as planned on the Per-protocol population (78 participants) . The Per-protocol population consisted of all randomized participants with at least one instillation and one post-baseline assessment without any major protocol deviation (defined as impacting the primary endpoint)'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Corneal Fluorescein Staining Score at Day 90 (Visit 5)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CBL-101 Eye Drops', 'description': 'Participants received CBL-101 Eye Drops, 3 to 6 times daily for 3 months in both eyes.\n\nCBL-101 Eye Drops: CE-marked medical device with 0.15% sodium hyaluronate and 0.5% polyethylene glycol (PEG)'}, {'id': 'OG001', 'title': 'Vismed® Multi Eye Drops', 'description': 'Participants received Vismed® Multi Eye Drops, 3 to 6 times daily for 3 months in both eyes.\n\nVismed® Multi: CE-marked medical device with 0.18% sodium hyaluronate'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.2', 'spread': '0.1', 'groupId': 'OG000'}, {'value': '-0.8', 'spread': '0.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0186', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Significance level of 0.05', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjustment for baseline'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (Day 0), Visit 5 (Day 90)', 'description': 'Mean change from baseline (CFB) in the study eye in Corneal Fluorescein Staining scored according to the Oxford Scheme.\n\nThe Oxford Scheme is a validated scale consisting of a series of panels labelled A to E in order of increasing severity. Grade 0 corresponds to panel A increasing to Grade 5 corresponding to more than Panel E, with punctate dots representing staining. The Corneal region is graded separately from 0 (best outcome) to 5 (worst outcome).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Two participants of the per-protocol population, one in each group withdrew before the Day 90 visit.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Nasal Conjunctival Fluorescein Staining Score at Day 7 (Visit 3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CBL-101 Eye Drops', 'description': 'Participants received CBL-101 Eye Drops, 3 to 6 times daily for 3 months in both eyes.\n\nCBL-101 Eye Drops: CE-marked medical device with 0.15% sodium hyaluronate and 0.5% polyethylene glycol (PEG)'}, {'id': 'OG001', 'title': 'Vismed® Multi Eye Drops', 'description': 'Participants received Vismed® Multi Eye Drops, 3 to 6 times daily for 3 months in both eyes.\n\nVismed® Multi: CE-marked medical device with 0.18% sodium hyaluronate'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.6', 'spread': '0.1', 'groupId': 'OG000'}, {'value': '-0.6', 'spread': '0.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '> 0.05', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Significance level of 0.05', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjustment for baseline'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (Day 0), Visit 3 (Day 7)', 'description': 'Mean change from baseline (CFB) in the study eye in Nasal conjunctival Fluorescein Staining scored according to the Oxford Scheme.\n\nThe Oxford Scheme is a validated scale consisting of a series of panels labelled A to E in order of increasing severity. Grade 0 corresponds to panel A increasing to Grade 5 corresponding to more than Panel E, with punctate dots representing staining. The Nasal conjunctival region is graded separately from 0 (best outcome) to 5 (worst outcome).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the Per-protocol population as planned. Two participants of the per-protocol population, one in each group did not have the Day 7 visit.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Nasal Conjunctival Fluorescein Staining Score at Day 28 (Visit 4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CBL-101 Eye Drops', 'description': 'Participants received CBL-101 Eye Drops, 3 to 6 times daily for 3 months in both eyes.\n\nCBL-101 Eye Drops: CE-marked medical device with 0.15% sodium hyaluronate and 0.5% polyethylene glycol (PEG)'}, {'id': 'OG001', 'title': 'Vismed® Multi Eye Drops', 'description': 'Participants received Vismed® Multi Eye Drops, 3 to 6 times daily for 3 months in both eyes.\n\nVismed® Multi: CE-marked medical device with 0.18% sodium hyaluronate'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.0', 'spread': '0.1', 'groupId': 'OG000'}, {'value': '-0.9', 'spread': '0.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '> 0.05', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Significance level of 0.05', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjustment for baseline'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (Day 0), Visit 4 (Day 28)', 'description': 'Mean change from baseline (CFB) in the study eye in Nasal conjunctival Fluorescein Staining scored according to the Oxford Scheme.\n\nThe Oxford Scheme is a validated scale consisting of a series of panels labelled A to E in order of increasing severity. Grade 0 corresponds to panel A increasing to Grade 5 corresponding to more than Panel E, with punctate dots representing staining. The Nasal conjunctival region is graded separately from 0 (best outcome) to 5 (worst outcome).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed as planned on the Per-protocol population (78 participants) . The Per-protocol population consisted of all randomized participants with at least one instillation and one post-baseline assessment without any major protocol deviation (defined as impacting the primary endpoint)'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Nasal Conjunctival Fluorescein Staining Score at Day 90 (Visit 5)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CBL-101 Eye Drops', 'description': 'Participants received CBL-101 Eye Drops, 3 to 6 times daily for 3 months in both eyes.\n\nCBL-101 Eye Drops: CE-marked medical device with 0.15% sodium hyaluronate and 0.5% polyethylene glycol (PEG)'}, {'id': 'OG001', 'title': 'Vismed® Multi Eye Drops', 'description': 'Participants received Vismed® Multi Eye Drops, 3 to 6 times daily for 3 months in both eyes.\n\nVismed® Multi: CE-marked medical device with 0.18% sodium hyaluronate'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.4', 'spread': '0.1', 'groupId': 'OG000'}, {'value': '-0.8', 'spread': '0.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0011', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Significance level of 0.05', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjustment for baseline'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (Day 0), Visit 5 (Day 90)', 'description': 'Mean change from baseline (CFB) in the study eye in Nasal Conjunctival Fluorescein Staining scored according to the Oxford Scheme.\n\nThe Oxford Scheme is a validated scale consisting of a series of panels labelled A to E in order of increasing severity. Grade 0 corresponds to panel A increasing to Grade 5 corresponding to more than Panel E, with punctate dots representing staining. The Nasal conjunctival region is graded separately from 0 (best outcome) to 5 (worst outcome).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Two participants of the per-protocol population, one in each group withdrew before the Day 90 visit.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Temporal Conjunctival Fluorescein Staining Score at Day 7 (Visit 3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CBL-101 Eye Drops', 'description': 'Participants received CBL-101 Eye Drops, 3 to 6 times daily for 3 months in both eyes.\n\nCBL-101 Eye Drops: CE-marked medical device with 0.15% sodium hyaluronate and 0.5% polyethylene glycol (PEG)'}, {'id': 'OG001', 'title': 'Vismed® Multi Eye Drops', 'description': 'Participants received Vismed® Multi Eye Drops, 3 to 6 times daily for 3 months in both eyes.\n\nVismed® Multi: CE-marked medical device with 0.18% sodium hyaluronate'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.6', 'spread': '0.1', 'groupId': 'OG000'}, {'value': '-0.4', 'spread': '0.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '> 0.05', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Significance level of 0.05', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjustment for baseline'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (Day 0), Visit 3 (Day 7)', 'description': 'Mean change from baseline (CFB) in the study eye in Temporal Conjunctival Fluorescein Staining scored according to the Oxford Scheme.\n\nThe Oxford Scheme is a validated scale consisting of a series of panels labelled A to E in order of increasing severity. Grade 0 corresponds to panel A increasing to Grade 5 corresponding to more than Panel E, with punctate dots representing staining. The Temporal conjunctival region is graded separately from 0 (best outcome) to 5 (worst outcome).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the Per-protocol population as planned. Two participants of the per-protocol population, one in each group did not have the Day 7 visit.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Temporal Conjunctival Fluorescein Staining Score at Day 28 (Visit 4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CBL-101 Eye Drops', 'description': 'Participants received CBL-101 Eye Drops, 3 to 6 times daily for 3 months in both eyes.\n\nCBL-101 Eye Drops: CE-marked medical device with 0.15% sodium hyaluronate and 0.5% polyethylene glycol (PEG)'}, {'id': 'OG001', 'title': 'Vismed® Multi Eye Drops', 'description': 'Participants received Vismed® Multi Eye Drops, 3 to 6 times daily for 3 months in both eyes.\n\nVismed® Multi: CE-marked medical device with 0.18% sodium hyaluronate'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.9', 'spread': '0.1', 'groupId': 'OG000'}, {'value': '-0.8', 'spread': '0.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '> 0.05', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Significance level of 0.05', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjustment for baseline'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (Day 0), Visit 4 (Day 28)', 'description': 'Mean change from baseline (CFB) in the study eye in Temporal Conjunctival Fluorescein Staining scored according to the Oxford Scheme.\n\nThe Oxford Scheme is a validated scale consisting of a series of panels labelled A to E in order of increasing severity. Grade 0 corresponds to panel A increasing to Grade 5 corresponding to more than Panel E, with punctate dots representing staining. The Temporal conjunctival region is graded separately from 0 (best outcome) to 5 (worst outcome).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed as planned on the Per-protocol population (78 participants) . The Per-protocol population consisted of all randomized participants with at least one instillation and one post-baseline assessment without any major protocol deviation (defined as impacting the primary endpoint)'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Temporal Conjunctival Fluorescein Staining Score at Day 90 (Visit 5)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CBL-101 Eye Drops', 'description': 'Participants received CBL-101 Eye Drops, 3 to 6 times daily for 3 months in both eyes.\n\nCBL-101 Eye Drops: CE-marked medical device with 0.15% sodium hyaluronate and 0.5% polyethylene glycol (PEG)'}, {'id': 'OG001', 'title': 'Vismed® Multi Eye Drops', 'description': 'Participants received Vismed® Multi Eye Drops, 3 to 6 times daily for 3 months in both eyes.\n\nVismed® Multi: CE-marked medical device with 0.18% sodium hyaluronate'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.4', 'spread': '0.1', 'groupId': 'OG000'}, {'value': '-0.9', 'spread': '0.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.005', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Significance level of 0.05', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjustment for baseline'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (Day 0), Visit 5 (Day 90)', 'description': 'Mean change from baseline (CFB) in the study eye in Temporal Conjunctival Fluorescein Staining scored according to the Oxford Scheme.\n\nThe Oxford Scheme is a validated scale consisting of a series of panels labelled A to E in order of increasing severity. Grade 0 corresponds to panel A increasing to Grade 5 corresponding to more than Panel E, with punctate dots representing staining. The Temporal conjunctival region is graded separately from 0 (best outcome) to 5 (worst outcome).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Two participants of the per-protocol population, one in each group withdrew before the Day 90 visit.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Global Sum Score of Dry Eye Symptoms at Day 28 (Visit 4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CBL-101 Eye Drops', 'description': 'Participants received CBL-101 Eye Drops, 3 to 6 times daily for 3 months in both eyes.\n\nCBL-101 Eye Drops: CE-marked medical device with 0.15% sodium hyaluronate and 0.5% polyethylene glycol (PEG)'}, {'id': 'OG001', 'title': 'Vismed® Multi Eye Drops', 'description': 'Participants received Vismed® Multi Eye Drops, 3 to 6 times daily for 3 months in both eyes.\n\nVismed® Multi: CE-marked medical device with 0.18% sodium hyaluronate'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.2', 'spread': '0.4', 'groupId': 'OG000'}, {'value': '-2.2', 'spread': '0.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0008', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Significance level of 0.05', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjustment for baseline'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Visit 4 (Day 28)', 'description': 'The global sum score (scale 0-28) of dry eye symptoms assessed 7 items: sensation of dryness, foreign body, burning, stinging, itching, blurred vision, sensitivity to light, each graded from 0 (absent) to 4(severe and/or disabling and constant).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed as planned on the Per-protocol population (78 participants) . The Per-protocol population consisted of all randomized participants with at least one instillation and one post-baseline assessment without any major protocol deviation (defined as impacting the primary endpoint)'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Global Sum Score of Dry Eye Symptoms at Day 90 (Visit 5)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CBL-101 Eye Drops', 'description': 'Participants received CBL-101 Eye Drops, 3 to 6 times daily for 3 months in both eyes.\n\nCBL-101 Eye Drops: CE-marked medical device with 0.15% sodium hyaluronate and 0.5% polyethylene glycol (PEG)'}, {'id': 'OG001', 'title': 'Vismed® Multi Eye Drops', 'description': 'Participants received Vismed® Multi Eye Drops, 3 to 6 times daily for 3 months in both eyes.\n\nVismed® Multi: CE-marked medical device with 0.18% sodium hyaluronate'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.1', 'spread': '0.4', 'groupId': 'OG000'}, {'value': '-3.1', 'spread': '0.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0026', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Significance level of 0.05', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjustment for baseline'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Visit 5 (Day 90)', 'description': 'The global sum score (scale 0-28) of dry eye symptoms assessed 7 items: sensation of dryness, foreign body, burning, stinging, itching, blurred vision, sensitivity to light, each graded from 0 (absent) to 4 (severe and/or disabling and constant).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Two participants of the per-protocol population, one in each group withdrew before the Day 90 visit.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Ocular Surface Disease-Quality of Life (OSD-QoL®) at Day 90 (Visit 5)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CBL-101 Eye Drops', 'description': 'Participants received CBL-101 Eye Drops, 3 to 6 times daily for 3 months in both eyes.\n\nCBL-101 Eye Drops: CE-marked medical device with 0.15% sodium hyaluronate and 0.5% polyethylene glycol (PEG)'}, {'id': 'OG001', 'title': 'Vismed® Multi Eye Drops', 'description': 'Participants received Vismed® Multi Eye Drops, 3 to 6 times daily for 3 months in both eyes.\n\nVismed® Multi: CE-marked medical device with 0.18% sodium hyaluronate'}], 'classes': [{'title': 'Daily activities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12.0', 'spread': '1.9', 'groupId': 'OG000'}, {'value': '5.3', 'spread': '2.2', 'groupId': 'OG001'}]}]}, {'title': 'Handicap and work difficulties', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10.8', 'spread': '2.0', 'groupId': 'OG000'}, {'value': '2.4', 'spread': '2.0', 'groupId': 'OG001'}]}]}, {'title': 'Giving up makeup', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12.2', 'spread': '3.9', 'groupId': 'OG000'}, {'value': '5.5', 'spread': '4.2', 'groupId': 'OG001'}]}]}, {'title': 'Acknowledgement of the disease', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.8', 'spread': '3.6', 'groupId': 'OG000'}, {'value': '2.6', 'spread': '4.2', 'groupId': 'OG001'}]}]}, {'title': 'Acceptance of the disease', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.5', 'spread': '3.6', 'groupId': 'OG000'}, {'value': '-1.5', 'spread': '4.1', 'groupId': 'OG001'}]}]}, {'title': 'Fear for the future', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '15.5', 'spread': '2.2', 'groupId': 'OG000'}, {'value': '5.3', 'spread': '2.6', 'groupId': 'OG001'}]}]}, {'title': 'Emotional well-being', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.8', 'spread': '1.9', 'groupId': 'OG000'}, {'value': '2.6', 'spread': '2.2', 'groupId': 'OG001'}]}]}, {'title': 'Global Question', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '17.5', 'spread': '3.0', 'groupId': 'OG000'}, {'value': '9.1', 'spread': '3.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.077', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Significance level of 0.05 . P-Value result provided only for Global Question', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjustment for baseline'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (Day 0), Visit 5 (Day 90)', 'description': 'The OSD-QoL® questionnaire is a validated instrument for measuring dry eye severity and impairment. It includes 28 items divided into 7 dimensions: Daily activities, Difficulties with work and handicap, Giving up makeup, Acknowledgement of the disease, Acceptance of the disease, Fear for the future, and Emotional well-being. A Global Question: "How do you feel when considering your eye problems?" (included in the Fear for the future dimension) was also evaluated separately. The converted score for each dimension ranges from 0 to 100, with a higher score reflecting a better quality of life.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included participants in the per-protocol population with evaluable Global question on Day 0 and Day 90.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Tear Film Break Up Time (TFBUT) at Day 7 (Visit 3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CBL-101 Eye Drops', 'description': 'Participants received CBL-101 Eye Drops, 3 to 6 times daily for 3 months in both eyes.\n\nCBL-101 Eye Drops: CE-marked medical device with 0.15% sodium hyaluronate and 0.5% polyethylene glycol (PEG)'}, {'id': 'OG001', 'title': 'Vismed® Multi Eye Drops', 'description': 'Participants received Vismed® Multi Eye Drops, 3 to 6 times daily for 3 months in both eyes.\n\nVismed® Multi: CE-marked medical device with 0.18% sodium hyaluronate'}], 'classes': [{'categories': [{'measurements': [{'value': '0.9', 'spread': '0.2', 'groupId': 'OG000'}, {'value': '0.7', 'spread': '0.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.6097', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Significance level of 0.05', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjustment for baseline'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (Day 0), Visit 3 (Day 7)', 'description': 'The Tear Film Break Up Time (TFBUT) after fluorescein instillation, measured the time between the last blink and the first appearance of a dry spot or disruption of the tear film. The TFBUT was measured in tenths of seconds with a stopwatch provided to the sites. It was conducted 3 times and the mean was calculated.', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the Per-protocol population as planned. Two participants of the per-protocol population, one in each group did not have the Day 7 visit.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Tear Film Break Up Time (TFBUT) at Day 28 (Visit 4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CBL-101 Eye Drops', 'description': 'Participants received CBL-101 Eye Drops, 3 to 6 times daily for 3 months in both eyes.\n\nCBL-101 Eye Drops: CE-marked medical device with 0.15% sodium hyaluronate and 0.5% polyethylene glycol (PEG)'}, {'id': 'OG001', 'title': 'Vismed® Multi Eye Drops', 'description': 'Participants received Vismed® Multi Eye Drops, 3 to 6 times daily for 3 months in both eyes.\n\nVismed® Multi: CE-marked medical device with 0.18% sodium hyaluronate'}], 'classes': [{'categories': [{'measurements': [{'value': '1.2', 'spread': '0.2', 'groupId': 'OG000'}, {'value': '0.8', 'spread': '0.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.231', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Significance level of 0.05', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjustment for baseline'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (Day 0), Visit 4 (Day 28)', 'description': 'The Tear Film Break Up Time (TFBUT) after fluorescein instillation, measured the time between the last blink and the first appearance of a dry spot or disruption of the tear film. The TFBUT was measured in tenths of seconds with a stopwatch provided to the sites. It was conducted 3 times and the means was calculated.', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed as planned on the Per-protocol population (78 participants) . The Per-protocol population consisted of all randomized participants with at least one instillation and one post-baseline assessment without any major protocol deviation (defined as impacting the primary endpoint)'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Tear Film Break Up Time (TFBUT) at Day 90 (Visit 5)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CBL-101 Eye Drops', 'description': 'Participants received CBL-101 Eye Drops, 3 to 6 times daily for 3 months in both eyes.\n\nCBL-101 Eye Drops: CE-marked medical device with 0.15% sodium hyaluronate and 0.5% polyethylene glycol (PEG)'}, {'id': 'OG001', 'title': 'Vismed® Multi Eye Drops', 'description': 'Participants received Vismed® Multi Eye Drops, 3 to 6 times daily for 3 months in both eyes.\n\nVismed® Multi: CE-marked medical device with 0.18% sodium hyaluronate'}], 'classes': [{'categories': [{'measurements': [{'value': '1.7', 'spread': '0.2', 'groupId': 'OG000'}, {'value': '0.7', 'spread': '0.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0135', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Significance level of 0.05', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjustment for baseline'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (Day 0), Visit 5 (Day 90)', 'description': 'The Tear Film Break Up Time (TFBUT) after fluorescein instillation, measured the time between the last blink and the first appearance of a dry spot or disruption of the tear film. The TFBUT was measured in tenths of seconds with a stopwatch provided to the sites. It was conducted 3 times and the means was calculated.', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Two participants of the per-protocol population, one in each group withdrew before the Day 90 visit.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Schirmer Test at Day 28 (Visit 4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CBL-101 Eye Drops', 'description': 'Participants received CBL-101 Eye Drops, 3 to 6 times daily for 3 months in both eyes.\n\nCBL-101 Eye Drops: CE-marked medical device with 0.15% sodium hyaluronate and 0.5% polyethylene glycol (PEG)'}, {'id': 'OG001', 'title': 'Vismed® Multi Eye Drops', 'description': 'Participants received Vismed® Multi Eye Drops, 3 to 6 times daily for 3 months in both eyes.\n\nVismed® Multi: CE-marked medical device with 0.18% sodium hyaluronate'}], 'classes': [{'categories': [{'measurements': [{'value': '1.9', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '1.5', 'spread': '0.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.575', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Significance level of 0.05', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjustment for baseline'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (Day 0), Visit 4 (Day 28)', 'description': "Tear fluid secretion was assessed by the unanaesthetized Schirmer's test in the study eye with graduated strips in millimeters.\n\nSchirmer paper test strips were carefully inserted over the lower eyelid margin. The strips were removed after 5 minutes and the amount of tear fluid secretion read to the nearest mm from the graduated strip markings.", 'unitOfMeasure': 'mm / 5 min', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included participants in the per-protocol population with evaluable Schirmer test on Day 0 and Day 28.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'CBL-101 Eye Drops', 'description': 'Participants received CBL-101 Eye Drops, 3 to 6 times daily for 3 months in both eyes.\n\nCBL-101 Eye Drops: CE-marked medical device with 0.15% sodium hyaluronate and 0.5% polyethylene glycol (PEG)'}, {'id': 'FG001', 'title': 'Vismed® Multi Eye Drops', 'description': 'Participants received Vismed® Multi Eye Drops, 3 to 6 times daily for 3 months in both eyes.\n\nVismed® Multi: CE-marked medical device with 0.18% sodium hyaluronate'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'comment': 'Randomized', 'achievements': [{'groupId': 'FG000', 'numSubjects': '45'}, {'groupId': 'FG001', 'numSubjects': '38'}]}, {'type': 'Safety Population', 'achievements': [{'groupId': 'FG000', 'numSubjects': '45'}, {'groupId': 'FG001', 'numSubjects': '38'}]}, {'type': 'Intention-to-treat Population', 'achievements': [{'groupId': 'FG000', 'numSubjects': '45'}, {'groupId': 'FG001', 'numSubjects': '38'}]}, {'type': 'Per Protocol Population Day 7', 'achievements': [{'comment': 'One participant did not attend the Day 7 visit. 2 participants were excluded for major deviation: 1 withdrawal before Day 28, 1 had disallowed concomitant therapy.', 'groupId': 'FG000', 'numSubjects': '42'}, {'comment': 'One participant did not attend the Day 7 visit. 3 participants were excluded for major deviation:3 had inclusion criteria violation.', 'groupId': 'FG001', 'numSubjects': '34'}]}, {'type': 'Per Protocol Population Day 28', 'achievements': [{'comment': '2 participants were excluded for major deviation: 1 withdrawal before Day 28, 1 had disallowed concomitant therapy', 'groupId': 'FG000', 'numSubjects': '43'}, {'comment': '3 participants were excluded for major deviation:3 had inclusion criteria violation', 'groupId': 'FG001', 'numSubjects': '35'}]}, {'type': 'Per Protocol Population Day 90', 'achievements': [{'comment': 'One participant withdrew after Day 28', 'groupId': 'FG000', 'numSubjects': '42'}, {'comment': 'One participant withdrew after Day 28', 'groupId': 'FG001', 'numSubjects': '34'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '43'}, {'groupId': 'FG001', 'numSubjects': '37'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Participants were recruited from 15 sites in France and 3 sites in Belgium', 'preAssignmentDetails': '87 enrolled participants underwent a washout period of 2 weeks with povidone 2% eye drops in both eyes. Following completion of the washout period, 83 participants met inclusion criteria and were randomized either to CBL-101 or Vismed Multi treatment group. Both eyes of each participant were treated with the assigned eye drops.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '83', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'CBL-101 Eye Drops', 'description': 'Participants received CBL-101 Eye Drops, 3 to 6 times daily for 3 months in both eyes.\n\nCBL-101 Eye Drops: CE-marked medical device with 0.15% sodium hyaluronate, and 0.5% polyethylene glycol (PEG)'}, {'id': 'BG001', 'title': 'Vismed® Multi Eye Drops', 'description': 'Participants received Vismed® Multi Eye Drops, 3 to 6 times daily for 3 months in both eyes.\n\nVismed® Multi: CE-marked medical device with 0.18% sodium hyaluronate'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '83', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '63.8', 'spread': '14.0', 'groupId': 'BG000'}, {'value': '60.6', 'spread': '14.1', 'groupId': 'BG001'}, {'value': '62.3', 'spread': '14.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '83', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '20', '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': 'Region of Enrollment', 'classes': [{'title': 'France', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '83', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}]}]}, {'title': 'Belgium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '83', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Ocular surface fluorescein staining', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '83', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '5.4', 'spread': '1.3', 'groupId': 'BG000'}, {'value': '5.3', 'spread': '1.5', 'groupId': 'BG001'}, {'value': '5.3', 'spread': '1.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The Ocular Surface Fluorescein Staining (OSFS) was scored according to a scale (Oxford Scheme) with a total score ranging from a minimum of 0 (best outcome) to a maximum of 15 (worst outcome).\n\nThe OSFS total score is the sum of 3 subscores (corneal, nasal and temporal regions). Each subscore ranges from a minimum of 0 (best outcome) to a maximum of 5 (worst outcome).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Corneal fluorescein staining score', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '83', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1.8', 'spread': '0.7', 'groupId': 'BG000'}, {'value': '1.9', 'spread': '0.8', 'groupId': 'BG001'}, {'value': '1.9', 'spread': '0.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The Corneal fluorescein staining score was measured according to a scale (Oxford Scheme) ranging from a minimum of 0 (best outcome) to a maximum of 5 (worst outcome).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Nasal conjunctival fluorescein staining score', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '83', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1.8', 'spread': '0.7', 'groupId': 'BG000'}, {'value': '1.7', 'spread': '0.7', 'groupId': 'BG001'}, {'value': '1.8', 'spread': '0.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The Nasal conjunctival fluorescein staining score was measured according to a scale (Oxford Scheme) ranging from a minimum of 0 (best outcome) to a maximum of 5 (worst outcome).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Temporal conjunctival fluorescein staining score', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '83', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1.7', 'spread': '0.7', 'groupId': 'BG000'}, {'value': '1.7', 'spread': '0.5', 'groupId': 'BG001'}, {'value': '1.7', 'spread': '0.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The Temporal conjunctival fluorescein staining score was measured according to a scale (Oxford Scheme) ranging from a minimum of 0 (best outcome) to a maximum of 5 (worst outcome).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Global dry eye symptoms score', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '83', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '8.8', 'spread': '2.7', 'groupId': 'BG000'}, {'value': '8.2', 'spread': '3.3', 'groupId': 'BG001'}, {'value': '8.5', 'spread': '3.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The Global dry eye symptom score was the sum score (scale 0-28) of dry eye symptoms assessing 7 items: sensation of dryness, foreign body, burning, stinging, itching, blurred vision, sensitivity to light, each graded from 0 (absent) to 4 (severe and/or disabling and constant).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Ocular surface disease-Quality of life (OSD-QoL®): Global question', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '45.6', 'spread': '21.8', 'groupId': 'BG000'}, {'value': '53.9', 'spread': '22.1', 'groupId': 'BG001'}, {'value': '49.3', 'spread': '22.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The Global Question of the OSD-QoL questionnaire was measured on a scale ranging from 0 (worst outcome) to 4 (best outcome). The result was converted to a reporting score ranging from 0 (poor quality of life) to 100 (good quality of life).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Some of the Quality of Life questionnaires could not be analyzed'}, {'title': 'Tear film break-up time (TFBUT)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '83', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '5.5', 'spread': '1.6', 'groupId': 'BG000'}, {'value': '6.0', 'spread': '1.5', 'groupId': 'BG001'}, {'value': '5.7', 'spread': '1.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The Tear Film Break Up Time (TFBUT) after fluorescein instillation, measured the time between the last blink and the first appearance of a dry spot or disruption of the tear film. The TFBUT was measured in tenths of seconds with a stopwatch provided to the sites. It was conducted 3 times and the mean was calculated.', 'unitOfMeasure': 'seconds', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': "Schirmer's test", 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '83', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '6.8', 'spread': '3.7', 'groupId': 'BG000'}, {'value': '7.4', 'spread': '2.9', 'groupId': 'BG001'}, {'value': '7.1', 'spread': '3.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': "Tear fluid secretion was assessed by the unanaesthetized Schirmer's test in the study eye with graduated strips in millimeters.\n\nSchirmer paper test strips were carefully inserted over the lower eyelid margin. The strips were removed after 5 minutes and the amount of tear fluid secretion read to the nearest mm from the graduated strip markings.", 'unitOfMeasure': 'millimeters', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Baseline participants included all 83 randomized participants.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-06-06', 'size': 646275, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-01-24T07:43', 'hasProtocol': True}, {'date': '2019-11-25', 'size': 548986, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-01-24T07:44', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 87}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2019-09-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-15', 'studyFirstSubmitDate': '2016-11-21', 'resultsFirstSubmitDate': '2023-01-27', 'studyFirstSubmitQcDate': '2016-11-23', 'lastUpdatePostDateStruct': {'date': '2024-06-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-01-15', 'studyFirstPostDateStruct': {'date': '2016-11-29', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2024-06-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Ocular Surface Fluorescein Staining Score at Day 28', 'timeFrame': 'Baseline (Day 0), Visit 4 (Day 28)', 'description': 'Mean change from baseline (CFB) in the study eye in Ocular Surface Fluorescein Staining (OSFS) scored according to the Oxford Scheme.\n\nThe Oxford Scheme is a validated scale consisting of a series of panels labelled A to E in order of increasing severity. Grade 0 corresponds to panel A increasing to Grade 5 corresponding to more than Panel E, with punctate dots representing staining. The 3 regions, cornea, nasal and temporal bulbar conjunctiva are graded separately from 0 to 5, with the OSFS score ranging from 0 (best outcome) to 15 (worst outcome). The OSFS is the sum score of the 3 subscores (cornea, nasal and temporal regions).\n\nThe study eye was the eligible eye with the highest OSFS score at baseline, which needed to be ≥4 and ≤9 on the 15-grade Oxford Scheme. If both eyes were eligible and had the same OSFS score, the study eye was the right eye.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Ocular Surface Fluorescein Staining Score at Day 7 (Visit 3)', 'timeFrame': 'Baseline (Day 0), Visit 3 (Day 7)', 'description': 'Mean change from baseline (CFB) in the study eye in Ocular Surface Fluorescein Staining (OSFS) scored according to the Oxford Scheme.\n\nThe Oxford Scheme is a validated scale consisting of a series of panels labelled A to E in order of increasing severity. Grade 0 corresponds to panel A increasing to Grade 5 corresponding to more than Panel E, with punctate dots representing staining. The 3 regions, cornea, nasal and temporal bulbar conjunctiva are graded separately from 0 to 5, with the OSFS score ranging from 0 (best outcome) to 15 (worst outcome). The OSFS is the sum score of the 3 subscores (cornea, nasal and temporal regions).\n\nThe study eye was the eligible eye with the highest OSFS score at baseline, which needed to be ≥4 and ≤9 on the 15-grade Oxford Scheme. If both eyes were eligible and had the same OSFS score, the study eye was the right eye.'}, {'measure': 'Change From Baseline in Ocular Surface Fluorescein Staining Score at Day 90 (Visit 5)', 'timeFrame': 'Baseline (Day 0), Visit 5 (Day 90)', 'description': 'Mean change from baseline (CFB) in the study eye in Ocular Surface Fluorescein Staining (OSFS) scored according to the Oxford Scheme.\n\nThe Oxford Scheme is a validated scale consisting of a series of panels labelled A to E in order of increasing severity. Grade 0 corresponds to panel A increasing to Grade 5 corresponding to more than Panel E, with punctate dots representing staining. The 3 regions, cornea, nasal and temporal bulbar conjunctiva are graded separately from 0 to 5, with the OSFS score ranging from 0 (best outcome) to 15 (worst outcome). The OSFS is the sum score of the 3 subscores (cornea, nasal and temporal regions).\n\nThe study eye was the eligible eye with the highest OSFS score at baseline, which needed to be ≥4 and ≤9 on the 15-grade Oxford Scheme. If both eyes were eligible and had the same OSFS score, the study eye was the right eye.'}, {'measure': 'Change From Baseline in Corneal Fluorescein Staining Score at Day 7 (Visit 3)', 'timeFrame': 'Baseline (Day 0), Visit 3 (Day 7)', 'description': 'Mean change from baseline (CFB) in the study eye in Corneal Fluorescein Staining scored according to the Oxford Scheme.\n\nThe Oxford Scheme is a validated scale consisting of a series of panels labelled A to E in order of increasing severity. Grade 0 corresponds to panel A increasing to Grade 5 corresponding to more than Panel E, with punctate dots representing staining. The Corneal region is graded separately from 0 (best outcome) to 5 (worst outcome).'}, {'measure': 'Change From Baseline in Corneal Fluorescein Staining Score at Day 28 (Visit 4)', 'timeFrame': 'Baseline (Day 0), Visit 4 (Day 28)', 'description': 'Mean change from baseline (CFB) in the study eye in Corneal Fluorescein Staining scored according to the Oxford Scheme.\n\nThe Oxford Scheme is a validated scale consisting of a series of panels labelled A to E in order of increasing severity. Grade 0 corresponds to panel A increasing to Grade 5 corresponding to more than Panel E, with punctate dots representing staining. The Corneal region is graded separately from 0 (best outcome) to 5 (worst outcome).'}, {'measure': 'Change From Baseline in Corneal Fluorescein Staining Score at Day 90 (Visit 5)', 'timeFrame': 'Baseline (Day 0), Visit 5 (Day 90)', 'description': 'Mean change from baseline (CFB) in the study eye in Corneal Fluorescein Staining scored according to the Oxford Scheme.\n\nThe Oxford Scheme is a validated scale consisting of a series of panels labelled A to E in order of increasing severity. Grade 0 corresponds to panel A increasing to Grade 5 corresponding to more than Panel E, with punctate dots representing staining. The Corneal region is graded separately from 0 (best outcome) to 5 (worst outcome).'}, {'measure': 'Change From Baseline in Nasal Conjunctival Fluorescein Staining Score at Day 7 (Visit 3)', 'timeFrame': 'Baseline (Day 0), Visit 3 (Day 7)', 'description': 'Mean change from baseline (CFB) in the study eye in Nasal conjunctival Fluorescein Staining scored according to the Oxford Scheme.\n\nThe Oxford Scheme is a validated scale consisting of a series of panels labelled A to E in order of increasing severity. Grade 0 corresponds to panel A increasing to Grade 5 corresponding to more than Panel E, with punctate dots representing staining. The Nasal conjunctival region is graded separately from 0 (best outcome) to 5 (worst outcome).'}, {'measure': 'Change From Baseline in Nasal Conjunctival Fluorescein Staining Score at Day 28 (Visit 4)', 'timeFrame': 'Baseline (Day 0), Visit 4 (Day 28)', 'description': 'Mean change from baseline (CFB) in the study eye in Nasal conjunctival Fluorescein Staining scored according to the Oxford Scheme.\n\nThe Oxford Scheme is a validated scale consisting of a series of panels labelled A to E in order of increasing severity. Grade 0 corresponds to panel A increasing to Grade 5 corresponding to more than Panel E, with punctate dots representing staining. The Nasal conjunctival region is graded separately from 0 (best outcome) to 5 (worst outcome).'}, {'measure': 'Change From Baseline in Nasal Conjunctival Fluorescein Staining Score at Day 90 (Visit 5)', 'timeFrame': 'Baseline (Day 0), Visit 5 (Day 90)', 'description': 'Mean change from baseline (CFB) in the study eye in Nasal Conjunctival Fluorescein Staining scored according to the Oxford Scheme.\n\nThe Oxford Scheme is a validated scale consisting of a series of panels labelled A to E in order of increasing severity. Grade 0 corresponds to panel A increasing to Grade 5 corresponding to more than Panel E, with punctate dots representing staining. The Nasal conjunctival region is graded separately from 0 (best outcome) to 5 (worst outcome).'}, {'measure': 'Change From Baseline in Temporal Conjunctival Fluorescein Staining Score at Day 7 (Visit 3)', 'timeFrame': 'Baseline (Day 0), Visit 3 (Day 7)', 'description': 'Mean change from baseline (CFB) in the study eye in Temporal Conjunctival Fluorescein Staining scored according to the Oxford Scheme.\n\nThe Oxford Scheme is a validated scale consisting of a series of panels labelled A to E in order of increasing severity. Grade 0 corresponds to panel A increasing to Grade 5 corresponding to more than Panel E, with punctate dots representing staining. The Temporal conjunctival region is graded separately from 0 (best outcome) to 5 (worst outcome).'}, {'measure': 'Change From Baseline in Temporal Conjunctival Fluorescein Staining Score at Day 28 (Visit 4)', 'timeFrame': 'Baseline (Day 0), Visit 4 (Day 28)', 'description': 'Mean change from baseline (CFB) in the study eye in Temporal Conjunctival Fluorescein Staining scored according to the Oxford Scheme.\n\nThe Oxford Scheme is a validated scale consisting of a series of panels labelled A to E in order of increasing severity. Grade 0 corresponds to panel A increasing to Grade 5 corresponding to more than Panel E, with punctate dots representing staining. The Temporal conjunctival region is graded separately from 0 (best outcome) to 5 (worst outcome).'}, {'measure': 'Change From Baseline in Temporal Conjunctival Fluorescein Staining Score at Day 90 (Visit 5)', 'timeFrame': 'Baseline (Day 0), Visit 5 (Day 90)', 'description': 'Mean change from baseline (CFB) in the study eye in Temporal Conjunctival Fluorescein Staining scored according to the Oxford Scheme.\n\nThe Oxford Scheme is a validated scale consisting of a series of panels labelled A to E in order of increasing severity. Grade 0 corresponds to panel A increasing to Grade 5 corresponding to more than Panel E, with punctate dots representing staining. The Temporal conjunctival region is graded separately from 0 (best outcome) to 5 (worst outcome).'}, {'measure': 'Change From Baseline in Global Sum Score of Dry Eye Symptoms at Day 28 (Visit 4)', 'timeFrame': 'Baseline, Visit 4 (Day 28)', 'description': 'The global sum score (scale 0-28) of dry eye symptoms assessed 7 items: sensation of dryness, foreign body, burning, stinging, itching, blurred vision, sensitivity to light, each graded from 0 (absent) to 4(severe and/or disabling and constant).'}, {'measure': 'Change From Baseline in Global Sum Score of Dry Eye Symptoms at Day 90 (Visit 5)', 'timeFrame': 'Baseline, Visit 5 (Day 90)', 'description': 'The global sum score (scale 0-28) of dry eye symptoms assessed 7 items: sensation of dryness, foreign body, burning, stinging, itching, blurred vision, sensitivity to light, each graded from 0 (absent) to 4 (severe and/or disabling and constant).'}, {'measure': 'Change From Baseline in the Ocular Surface Disease-Quality of Life (OSD-QoL®) at Day 90 (Visit 5)', 'timeFrame': 'Baseline (Day 0), Visit 5 (Day 90)', 'description': 'The OSD-QoL® questionnaire is a validated instrument for measuring dry eye severity and impairment. It includes 28 items divided into 7 dimensions: Daily activities, Difficulties with work and handicap, Giving up makeup, Acknowledgement of the disease, Acceptance of the disease, Fear for the future, and Emotional well-being. A Global Question: "How do you feel when considering your eye problems?" (included in the Fear for the future dimension) was also evaluated separately. The converted score for each dimension ranges from 0 to 100, with a higher score reflecting a better quality of life.'}, {'measure': 'Change From Baseline in Tear Film Break Up Time (TFBUT) at Day 7 (Visit 3)', 'timeFrame': 'Baseline (Day 0), Visit 3 (Day 7)', 'description': 'The Tear Film Break Up Time (TFBUT) after fluorescein instillation, measured the time between the last blink and the first appearance of a dry spot or disruption of the tear film. The TFBUT was measured in tenths of seconds with a stopwatch provided to the sites. It was conducted 3 times and the mean was calculated.'}, {'measure': 'Change From Baseline in Tear Film Break Up Time (TFBUT) at Day 28 (Visit 4)', 'timeFrame': 'Baseline (Day 0), Visit 4 (Day 28)', 'description': 'The Tear Film Break Up Time (TFBUT) after fluorescein instillation, measured the time between the last blink and the first appearance of a dry spot or disruption of the tear film. The TFBUT was measured in tenths of seconds with a stopwatch provided to the sites. It was conducted 3 times and the means was calculated.'}, {'measure': 'Change From Baseline in Tear Film Break Up Time (TFBUT) at Day 90 (Visit 5)', 'timeFrame': 'Baseline (Day 0), Visit 5 (Day 90)', 'description': 'The Tear Film Break Up Time (TFBUT) after fluorescein instillation, measured the time between the last blink and the first appearance of a dry spot or disruption of the tear film. The TFBUT was measured in tenths of seconds with a stopwatch provided to the sites. It was conducted 3 times and the means was calculated.'}, {'measure': 'Change From Baseline in Schirmer Test at Day 28 (Visit 4)', 'timeFrame': 'Baseline (Day 0), Visit 4 (Day 28)', 'description': "Tear fluid secretion was assessed by the unanaesthetized Schirmer's test in the study eye with graduated strips in millimeters.\n\nSchirmer paper test strips were carefully inserted over the lower eyelid margin. The strips were removed after 5 minutes and the amount of tear fluid secretion read to the nearest mm from the graduated strip markings."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dry Eye']}, 'referencesModule': {'references': [{'pmid': '36269661', 'type': 'RESULT', 'citation': 'Labetoulle M, Mortemousque B; CBL-101 Study Group. Performance and Safety of a Sodium Hyaluronate Tear Substitute with Polyethylene Glycol in Dry Eye Disease: A Multicenter, Investigator-Masked, Randomized, Noninferiority Trial. J Ocul Pharmacol Ther. 2022 Nov;38(9):607-616. doi: 10.1089/jop.2022.0048. Epub 2022 Oct 21.'}]}, 'descriptionModule': {'briefSummary': 'The primary objectives of this investigation are to show that the performance of CBL-101 Eye Drops is non-inferior to that of Vismed® Multi eye drops in subjects with moderate to severe keratoconjunctivitis sicca after 28 days, and to assess the safety of CBL-101 Eye Drops during a 90-day period with treatment administered 3 to 6 times per day.', 'detailedDescription': 'Participants in this multicenter, randomized study had a screening visit, then were randomized on Day 0 with follow-up visits on Day 7 (±1), Day 28 (± 3) and Day 90 (±10).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Subjects must be of legal age (at least 18) on the date the Informed Consent Form (ICF) is signed and with the capacity to provide voluntary informed consent\n2. Subjects must be able to read, understand, and provide written informed consent on the Ethics Committee (EC) approved ICF\n3. Subjects who are able and willing to comply with all treatment and follow-up, study procedures\n4. Subjects who have been using tear substitutes for at least 3 months prior to inclusion, and who will use multidose preservative-free artificial tear (Aqualarm U.P. povidone 2% eye drops in 10 mL bottles) up to 6 times a day for at least 2 weeks immediately prior to randomization\n5. Subjects with a score ≥ 1 for at least 2 out of the 7 following symptoms (rated 0 to 4): sensation of dryness, foreign body, burning, stinging, itching, blurred vision, sensitivity to light\n6. Subjects with at least 1 eye with the following signs of keratoconjunctivitis sicca :\n\n * Tear break-up time of ≤ 10sec (mean of 3 measurements) at both screening visit and inclusion visit\n * Total ocular surface staining score ≥ 4 and ≤ 9 at both screening visit and inclusion visit. This assessment combines corneal, nasal and temporal bulbar conjunctival fluorescein staining, each graded 0-5 according to the Oxford Scheme\n7. Subjects who have a decimal visual acuity (VA) with habitual correction equal to or better than 0.1 (Monoyer chart) in both eyes\n8. Subjects with no systemic treatment or who are receiving stable systemic treatment (unchanged for 1 month or longer)\n9. Female subjects who are not of childbearing potential or who have a negative urine pregnancy test result at screening\n\nExclusion Criteria:\n\nOcular Exclusion Criteria\n\n1. Subjects with moderate or severe blepharitis defined by at least moderate (a score of ≥ 2 from a range of 0 to 3) eyelid margin hyperemia or moderate eyelid swelling or both and at least moderate eyelid debris or moderate plugging of meibomian glands or both\n2. Subjects who have severe ocular dryness accompanied by one of the following:\n\n * Lid abnormality (except mild blepharitis)\n * Corneal disease\n * Ocular surface metaplasia\n * Filamentary keratitis\n * Corneal neovascularization\n3. Subjects who currently wear contact lenses or have worn contact lenses within 90 days prior to study start\n4. Subjects who have received ocular surgery, including laser surgery, in either eye within 180 days prior to study start\n5. Subjects with a history of ocular trauma, non-dry eye ocular inflammation, or ocular infection within 90 days prior to study start\n6. Subjects with a history of ocular allergic disease or ocular herpes within 1 year prior to study start\n7. Subjects with a history of any inflammatory ulcerative keratitis, recurrent corneal erosion, or uveitis\n\n Treatment Exclusion Criteria\n8. Subjects with known hypersensitivity or contraindications to any of the ingredients in the test or comparator products or ART\n9. Subjects with initiation of, or changes to, concomitant medication that could affect dry eye within 30 days prior to Visit 1 (Screening) or with planned initiation or changes of such medications during the study\n10. Subjects who have received ocular therapy (either eye) with any ophthalmic medication, except tear substitutes, within 2 weeks prior to study start\n11. Subjects expected to receive ocular therapy during the study\n12. Subjects treated with topical ocular steroidal or non-steroidal antiinflammatory medication within 30 days prior to study start\n13. Subjects expected to receive ocular therapy with immunosuppressants (e.g. cyclosporine) during the study or who have used ocular immunosuppressants within 90 days prior to study start\n14. Subjects who have received occlusion therapy with lacrimal or punctum plugs within 90 days prior to study start\n\n General Exclusion Criteria\n15. Female subjects who are sexually active and who do not fall into 1 of the following categories:\n\n * Post-menopausal\n * Surgically sterile\n * Using one of the following birth control methods throughout the duration of the study: Intrauterine device (at least for 14 days prior to study start) or Barrier method (condom or diaphragm) with spermicide (at least for 14 days prior to study start) or Hormonal contraception (same dose and same formulation for at least 6 months)\n16. Females who are breastfeeding\n17. Subjects participating in any drug or device clinical investigation within 30 days prior to entry into this study and, or during the period of study participation'}, 'identificationModule': {'nctId': 'NCT02975102', 'briefTitle': 'A Study to Evaluate the Performance and Safety of CBL-101 Versus Vismed® Multi Eye Drops in the Management of Dry Eye', 'organization': {'class': 'INDUSTRY', 'fullName': 'Laboratoire Chauvin'}, 'officialTitle': 'A Study to Evaluate the Performance and Safety of CBL-101 Versus Vismed® Multi Eye Drops in the Management of Dry Eye', 'orgStudyIdInfo': {'id': '2016-A01121-50'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CBL-101 Eye Drops', 'description': 'The test article, CBL-101 Eye Drops, is a CE-marked medical device containing 0.15% sodium hyaluronate and polyethylene glycol (PEG) 8000. An oxide (Oxyd®) used as a soft preservative, rapidly turns into oxygen, water and ions on contact with the eye. The formula is presented in 10 mL bottles.', 'interventionNames': ['Device: CBL-101 Eye Drops']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Vismed® Multi Eye Drops', 'description': 'The comparator product, Vismed® Multi ophthalmic solution (CE marked), contains 0.18% sodium hyaluronate, is unpreserved and presented in 10 mL bottles.', 'interventionNames': ['Device: Vismed® Multi Eye Drops']}], 'interventions': [{'name': 'CBL-101 Eye Drops', 'type': 'DEVICE', 'description': 'CBL-101 Eye Drops 3 to 6 times per day for 3 months.', 'armGroupLabels': ['CBL-101 Eye Drops']}, {'name': 'Vismed® Multi Eye Drops', 'type': 'DEVICE', 'description': 'Vismed® Multi 3 to 6 times per day for 3 months.', 'armGroupLabels': ['Vismed® Multi Eye Drops']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Huy', 'country': 'Belgium', 'facility': 'Dr. Nyst private office', 'geoPoint': {'lat': 50.51894, 'lon': 5.23284}}, {'zip': '33000', 'city': 'Bordeaux', 'country': 'France', 'facility': 'Pr Mortemousque private office', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}], 'overallOfficials': [{'name': 'Raphaele Siou Mermet, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Laboratoire Chauvin'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Laboratoire Chauvin', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Bausch & Lomb Incorporated', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}