Ignite Creation Date:
2025-12-25 @ 4:02 AM
Ignite Modification Date:
2025-12-26 @ 2:55 AM
Study NCT ID:
NCT03569202
Status:
COMPLETED
Last Update Posted:
2019-12-13
First Post:
2018-04-24
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Piiloset Trehalose Emulsion Eye Drop Study in Moderate or Severe Dry Eye
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015352', 'term': 'Dry Eye Syndromes'}, {'id': 'D008224', 'term': 'Lymphoma, Follicular'}, {'id': 'D022125', 'term': 'Lacerations'}], 'ancestors': [{'id': 'D007766', 'term': 'Lacrimal Apparatus Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jarmo.laihia@piiloset.fi', 'phone': '358 50 377 1212', 'title': 'Dr. Jarmo Laihia, Manager of Clinical & Formulation Development', 'organization': 'Finnsusp Ltd.'}, 'certainAgreement': {'otherDetails': "The disclosure restrictions on the PI are that the sponsor can review results communications 30 days prior to planned date of public release. If public release of information in communications may jeopardize protecting sponsor's immaterial rights, the sponsor can additionally embargo the communications for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Part 1: 1 day; Part 2: 10 days; Part 3: 30 days', 'description': 'ADE (adverse device effect); AE (adverse event); SADE (serious adverse device effect); SAE (serious adverse event); USADE (unanticipated serious adverse device effect)\n\nTotal Number of Participants at Risk (safety population); Emulsion Eye Drops: 3 + 9 + 26 = 38 participants; Control Eye Drops: 0 + 9 + 26 = 35 participants.\n\nAdverse events were collected throughout the study during visits to study site, in study diaries, and from direct contacts to study personnel between visits.', 'eventGroups': [{'id': 'EG000', 'title': 'Emulsion Eye Drops', 'description': 'Daily treatment with Piiloset Trehalose Emulsion Eye Drops\n\nAdverse events are reported for the safety population in all parts of the study, including all randomized subjects who received Piiloset Trehalose Emulsion Eye Drops at least once and from whom at least one safety measurement was obtained after randomization.', 'otherNumAtRisk': 38, 'deathsNumAtRisk': 38, 'otherNumAffected': 1, 'seriousNumAtRisk': 38, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control Eye Drops', 'description': 'Daily treatment with Hyaluronic Acid Eye Drops (a CE-marked medical device)\n\nAdverse events are reported for the safety population in all parts of the study, including all randomized subjects who received Hyaluronic Acid Eye Drops at least once and from whom at least one safety measurement was obtained after randomization.', 'otherNumAtRisk': 35, 'deathsNumAtRisk': 35, 'otherNumAffected': 0, 'seriousNumAtRisk': 35, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'AE (adverse event)', 'notes': 'Small cutaneous papules all over the body, judged by the Investigator to be unrelated to study treatment.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'EN ISO 14155:2011'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline OSDI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Emulsion Eye Drops', 'description': 'Daily treatment with Piiloset Trehalose Emulsion Eye Drops\n\nResults are reported for Part 3 only:\n\nTopical application of preservative-free multidose Piiloset Trehalose Emulsion Eye Drops on both eyes 3 times a day for 30 days'}, {'id': 'OG001', 'title': 'Control Eye Drops', 'description': 'Daily treatment with Hyaluronic Acid Eye Drops (a CE-marked medical device)\n\nResults are reported for Part 3 only:\n\nTopical application of preservative-free multidose Hyaluronic Acid Eye Drops on both eyes 3 times a day for 30 days'}], 'classes': [{'categories': [{'measurements': [{'value': '-24.64', 'spread': '16.186', 'groupId': 'OG000'}, {'value': '-26.53', 'spread': '14.620', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.662', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.8837', 'ciLowerLimit': '-6.7081', 'ciUpperLimit': '10.4756', 'pValueComment': 'A two-sided p-value less than 0.05 was considered statistically significant.', 'groupDescription': 'Between-group comparison, change from baseline', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-24.6445', 'ciLowerLimit': '-30.7199', 'ciUpperLimit': '-18.5692', 'pValueComment': 'A two-sided p-value less than 0.05 was considered statistically significant.', 'groupDescription': 'Within-group change from baseline', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '<0.0001', 'groupIds': ['OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-26.5283', 'ciLowerLimit': '-32.6036', 'ciUpperLimit': '-20.4529', 'pValueComment': 'A two-sided p-value less than 0.05 was considered statistically significant.', 'groupDescription': 'Within-group change from baseline', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'From baseline to Day 30 (Part 3)', 'description': 'Ocular Surface Disease Index (OSDI) is a questionnaire consisting of 12 questions subdivided into 3 subscales for measuring the frequency of dry eye symptoms, vision-related quality of life and environmental triggers during the previous week. Answers to each question are on a scale of 0 (None of the time) to 4 (All of the time). Both total OSDI and its subscale scores are on a scale of 0 to 100, calculated as follows: score = (sum of scores for questions answered/number of questions answered) x 25. Higher scores represent greater disability.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT) dataset'}, {'type': 'PRIMARY', 'title': 'Change From Baseline Tear Osmolarity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Emulsion Eye Drops', 'description': 'Daily treatment with Piiloset Trehalose Emulsion Eye Drops\n\nResults are reported for Part 3 only:\n\nTopical application of preservative-free multidose Piiloset Trehalose Emulsion Eye Drops on both eyes 3 times a day for 30 days'}, {'id': 'OG001', 'title': 'Control Eye Drops', 'description': 'Daily treatment with Hyaluronic Acid Eye Drops (a CE-marked medical device)\n\nResults are reported for Part 3 only:\n\nTopical application of preservative-free multidose Hyaluronic Acid Eye Drops on both eyes 3 times a day for 30 days'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.75', 'spread': '16.224', 'groupId': 'OG000'}, {'value': '-1.77', 'spread': '21.531', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.575', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.9808', 'ciLowerLimit': '-13.6005', 'ciUpperLimit': '7.6390', 'pValueComment': 'A two-sided p-value less than 0.05 was considered statistically significant.', 'groupDescription': 'Between-group comparison, change from baseline', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.2098', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.7500', 'ciLowerLimit': '-12.2593', 'ciUpperLimit': '2.7593', 'pValueComment': 'A two-sided p-value less than 0.05 was considered statistically significant.', 'groupDescription': 'Within-group change from baseline', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.6381', 'groupIds': ['OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.7692', 'ciLowerLimit': '-9.2785', 'ciUpperLimit': '5.7401', 'pValueComment': 'A two-sided p-value less than 0.05 was considered statistically significant.', 'groupDescription': 'Within-group change from baseline', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'From baseline to Day 30 (Part 3)', 'description': 'Instrumental assay of tear fluid osmolarity (mOsm/L)', 'unitOfMeasure': 'mOsm/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT) dataset'}, {'type': 'PRIMARY', 'title': 'Change From Baseline TBUT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Emulsion Eye Drops', 'description': 'Daily treatment with Piiloset Trehalose Emulsion Eye Drops\n\nResults are reported for Part 3 only:\n\nTopical application of preservative-free multidose Piiloset Trehalose Emulsion Eye Drops on both eyes 3 times a day for 30 days'}, {'id': 'OG001', 'title': 'Control Eye Drops', 'description': 'Daily treatment with Hyaluronic Acid Eye Drops (a CE-marked medical device)\n\nResults are reported for Part 3 only:\n\nTopical application of preservative-free multidose Hyaluronic Acid Eye Drops on both eyes 3 times a day for 30 days'}], 'classes': [{'categories': [{'measurements': [{'value': '1.71', 'spread': '3.424', 'groupId': 'OG000'}, {'value': '0.87', 'spread': '1.809', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.271', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.8462', 'ciLowerLimit': '-0.6792', 'ciUpperLimit': '2.3715', 'pValueComment': 'A two-sided p-value less than 0.05 was considered statistically significant.', 'groupDescription': 'Between-group comparison, change from baseline', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.0025', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.7115', 'ciLowerLimit': '0.6330', 'ciUpperLimit': '2.7901', 'pValueComment': 'A two-sided p-value less than 0.05 was considered statistically significant.', 'groupDescription': 'Within-group change from baseline', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.1134', 'groupIds': ['OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.8654', 'ciLowerLimit': '-0.2132', 'ciUpperLimit': '1.9440', 'pValueComment': 'A two-sided p-value less than 0.05 was considered statistically significant.', 'groupDescription': 'Within-group change from baseline', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'From baseline to Day 30 (Part 3)', 'description': 'Tear film break-up time (TBUT) (s)', 'unitOfMeasure': 's', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT) dataset'}, {'type': 'SECONDARY', 'title': 'Change From Baseline Blink Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Emulsion Eye Drops', 'description': 'Daily treatment with Piiloset Trehalose Emulsion Eye Drops\n\nResults are reported for Part 3 only:\n\nTopical application of preservative-free multidose Piiloset Trehalose Emulsion Eye Drops on both eyes 3 times a day for 30 days'}, {'id': 'OG001', 'title': 'Control Eye Drops', 'description': 'Daily treatment with Hyaluronic Acid Eye Drops (a CE-marked medical device)\n\nResults are reported for Part 3 only:\n\nTopical application of preservative-free multidose Hyaluronic Acid Eye Drops on both eyes 3 times a day for 30 days'}], 'classes': [{'categories': [{'measurements': [{'value': '0.02', 'spread': '8.721', 'groupId': 'OG000'}, {'value': '-2.15', 'spread': '10.161', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.412', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.1731', 'ciLowerLimit': '-3.1016', 'ciUpperLimit': '7.4477', 'pValueComment': 'A two-sided p-value less than 0.05 was considered statistically significant.', 'groupDescription': 'Between-group comparison, change from baseline', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.9918', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.01923', 'ciLowerLimit': '-3.7105', 'ciUpperLimit': '3.7490', 'pValueComment': 'A two-sided p-value less than 0.05 was considered statistically significant.', 'groupDescription': 'Within-group change from baseline', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.2516', 'groupIds': ['OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.1538', 'ciLowerLimit': '-5.8836', 'ciUpperLimit': '1.5759', 'pValueComment': 'A two-sided p-value less than 0.05 was considered statistically significant.', 'groupDescription': 'Within-group change from baseline', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'From baseline to Day 30 (Part 3)', 'description': 'Measurement of spontaneous eyelid blinks per minute', 'unitOfMeasure': 'Blinks/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT) dataset'}, {'type': 'SECONDARY', 'title': 'Change From Baseline Ocular Protection Index (OPI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Emulsion Eye Drops', 'description': 'Daily treatment with Piiloset Trehalose Emulsion Eye Drops\n\nResults are reported for Part 3 only:\n\nTopical application of preservative-free multidose Piiloset Trehalose Emulsion Eye Drops on both eyes 3 times a day for 30 days'}, {'id': 'OG001', 'title': 'Control Eye Drops', 'description': 'Daily treatment with Hyaluronic Acid Eye Drops (a CE-marked medical device)\n\nResults are reported for Part 3 only:\n\nTopical application of preservative-free multidose Hyaluronic Acid Eye Drops on both eyes 3 times a day for 30 days'}], 'classes': [{'categories': [{'measurements': [{'value': '0.56', 'spread': '1.078', 'groupId': 'OG000'}, {'value': '0.05', 'spread': '0.680', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.047', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.5093', 'ciLowerLimit': '0.007267', 'ciUpperLimit': '1.0113', 'pValueComment': 'A two-sided p-value less than 0.05 was considered statistically significant.', 'groupDescription': 'Between-group comparison, change from baseline', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.0026', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.5596', 'ciLowerLimit': '0.2046', 'ciUpperLimit': '0.9146', 'pValueComment': 'A two-sided p-value less than 0.05 was considered statistically significant.', 'groupDescription': 'Within-group change from baseline', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.7770', 'groupIds': ['OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.05032', 'ciLowerLimit': '-0.3047', 'ciUpperLimit': '0.4053', 'pValueComment': 'A two-sided p-value less than 0.05 was considered statistically significant.', 'groupDescription': 'Within-group change from baseline', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'From baseline to Day 30 (Part 3)', 'description': 'OPI is the ratio of TBUT/IBI (IBI, interblink interval calculated from blink rate). An OPI value \\>1 indicates that TBUT (s) exceeds IBI (s) and that the ocular surface is mostly tear-film protected, because tear film break-ups do not take place within spontaneous blink cycles.', 'unitOfMeasure': 'ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT) dataset'}, {'type': 'SECONDARY', 'title': 'Change From Baseline Corneal Staining', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Emulsion Eye Drops', 'description': 'Daily treatment with Piiloset Trehalose Emulsion Eye Drops\n\nResults are reported for Part 3 only:\n\nTopical application of preservative-free multidose Piiloset Trehalose Emulsion Eye Drops on both eyes 3 times a day for 30 days'}, {'id': 'OG001', 'title': 'Control Eye Drops', 'description': 'Daily treatment with Hyaluronic Acid Eye Drops (a CE-marked medical device)\n\nResults are reported for Part 3 only:\n\nTopical application of preservative-free multidose Hyaluronic Acid Eye Drops on both eyes 3 times a day for 30 days'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.38', 'spread': '0.695', 'groupId': 'OG000'}, {'value': '-0.22', 'spread': '0.522', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.447', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Wilcoxon Z statistic', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-0.7604', 'pValueComment': 'A two-sided p-value less than 0.05 was considered statistically significant.', 'groupDescription': 'Between-group comparison, change from baseline', 'statisticalMethod': 'Wilcoxon rank sum test', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.014', 'groupIds': ['OG000'], 'pValueComment': 'A two-sided p-value less than 0.05 was considered statistically significant.', 'groupDescription': 'Within-group change from baseline', 'statisticalMethod': 'Wilcoxon rank sum test', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.070', 'groupIds': ['OG001'], 'pValueComment': 'A two-sided p-value less than 0.05 was considered statistically significant.', 'groupDescription': 'Within-group change from baseline', 'statisticalMethod': 'Wilcoxon rank sum test', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'From baseline to Day 30 (Part 3)', 'description': 'Corneal staining score is assessed as the average number of punctate dots on an ordinal scale of 0, 1, 2, 3, 4, and 5 (Oxford scale) when compared to a pictorial standard. The number of dots increases on a log scale. Higher score represents more intense staining.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-protocol (PP) dataset'}, {'type': 'SECONDARY', 'title': 'Change From Baseline Conjunctival (Temporal) Staining', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Emulsion Eye Drops', 'description': 'Daily treatment with Piiloset Trehalose Emulsion Eye Drops\n\nResults are reported for Part 3 only:\n\nTopical application of preservative-free multidose Piiloset Trehalose Emulsion Eye Drops on both eyes 3 times a day for 30 days'}, {'id': 'OG001', 'title': 'Control Eye Drops', 'description': 'Daily treatment with Hyaluronic Acid Eye Drops (a CE-marked medical device)\n\nResults are reported for Part 3 only:\n\nTopical application of preservative-free multidose Hyaluronic Acid Eye Drops on both eyes 3 times a day for 30 days'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.19', 'spread': '0.507', 'groupId': 'OG000'}, {'value': '-0.02', 'spread': '0.810', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.522', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Wilcoxon Z statistic', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-0.6396', 'pValueComment': 'A two-sided p-value less than 0.05 was considered statistically significant.', 'groupDescription': 'Between-group comparison, change from baseline', 'statisticalMethod': 'Wilcoxon rank sum test', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.119', 'groupIds': ['OG000'], 'pValueComment': 'A two-sided p-value less than 0.05 was considered statistically significant.', 'groupDescription': 'Within-group change from baseline', 'statisticalMethod': 'Wilcoxon rank sum test', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.900', 'groupIds': ['OG001'], 'pValueComment': 'A two-sided p-value less than 0.05 was considered statistically significant.', 'groupDescription': 'Within-group change from baseline', 'statisticalMethod': 'Wilcoxon rank sum test', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'From baseline to Day 30 (Part 3)', 'description': 'Conjunctival staining score is assessed as the average number of punctate dots on an ordinal scale of 0, 1, 2, 3, 4, and 5 (Oxford scale) when compared to a pictorial standard. The number of dots increases on a log scale. Higher score represents more intense staining.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-protocol (PP) dataset'}, {'type': 'SECONDARY', 'title': 'Change From Baseline Conjunctival (Nasal) Staining', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Emulsion Eye Drops', 'description': 'Daily treatment with Piiloset Trehalose Emulsion Eye Drops\n\nResults are reported for Part 3 only:\n\nTopical application of preservative-free multidose Piiloset Trehalose Emulsion Eye Drops on both eyes 3 times a day for 30 days'}, {'id': 'OG001', 'title': 'Control Eye Drops', 'description': 'Daily treatment with Hyaluronic Acid Eye Drops (a CE-marked medical device)\n\nResults are reported for Part 3 only:\n\nTopical application of preservative-free multidose Hyaluronic Acid Eye Drops on both eyes 3 times a day for 30 days'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.27', 'spread': '0.608', 'groupId': 'OG000'}, {'value': '-0.12', 'spread': '0.666', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.590', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Wilcoxon Z statistic', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-0.5387', 'pValueComment': 'A two-sided p-value less than 0.05 was considered statistically significant.', 'groupDescription': 'Between-group comparison, change from baseline', 'statisticalMethod': 'Wilcoxon rank sum test', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.043', 'groupIds': ['OG000'], 'pValueComment': 'A two-sided p-value less than 0.05 was considered statistically significant.', 'groupDescription': 'Within-group change from baseline', 'statisticalMethod': 'Wilcoxon rank sum test', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.442', 'groupIds': ['OG001'], 'pValueComment': 'A two-sided p-value less than 0.05 was considered statistically significant.', 'groupDescription': 'Within-group change from baseline', 'statisticalMethod': 'Wilcoxon rank sum test', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'From baseline to Day 30 (Part 3)', 'description': 'Conjunctival staining score is assessed as the average number of punctate dots on an ordinal scale of 0, 1, 2, 3, 4, and 5 (Oxford scale) when compared to a pictorial standard. The number of dots increases on a log scale. Higher score represents more intense staining.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-protocol (PP) dataset'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change From Baseline Visual Acuity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Emulsion Eye Drops', 'description': 'Daily treatment with Piiloset Trehalose Emulsion Eye Drops\n\nResults are reported for Part 3 only:\n\nTopical application of preservative-free multidose Piiloset Trehalose Emulsion Eye Drops on both eyes 3 times a day for 30 days'}, {'id': 'OG001', 'title': 'Control Eye Drops', 'description': 'Daily treatment with Hyaluronic Acid Eye Drops (a CE-marked medical device)\n\nResults are reported for Part 3 only:\n\nTopical application of preservative-free multidose Hyaluronic Acid Eye Drops on both eyes 3 times a day for 30 days'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.03', 'spread': '0.071', 'groupId': 'OG000'}, {'value': '-0.04', 'spread': '0.080', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From baseline to Day 30 (Part 3)', 'description': 'Best corrected visual acuity (ETDRS charts 1 \\& 2, 2000 series)', 'unitOfMeasure': 'logMAR chart log units', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety dataset'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change From Baseline Conjunctival Redness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Emulsion Eye Drops', 'description': 'Daily treatment with Piiloset Trehalose Emulsion Eye Drops\n\nResults are reported for Part 3 only:\n\nTopical application of preservative-free multidose Piiloset Trehalose Emulsion Eye Drops on both eyes 3 times a day for 30 days'}, {'id': 'OG001', 'title': 'Control Eye Drops', 'description': 'Daily treatment with Hyaluronic Acid Eye Drops (a CE-marked medical device)\n\nResults are reported for Part 3 only:\n\nTopical application of preservative-free multidose Hyaluronic Acid Eye Drops on both eyes 3 times a day for 30 days'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.46', 'spread': '0.647', 'groupId': 'OG000'}, {'value': '-0.27', 'spread': '0.652', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.357', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Wilcoxon Z statistic', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.9208', 'pValueComment': 'A two-sided p-value less than 0.05 was considered statistically significant.', 'groupDescription': 'Between-group comparison, change from baseline', 'statisticalMethod': 'Wilcoxon rank sum test', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.001', 'groupIds': ['OG000'], 'pValueComment': 'A two-sided p-value less than 0.05 was considered statistically significant.', 'groupDescription': 'Within-group change from baseline', 'statisticalMethod': 'Wilcoxon rank sum test', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.065', 'groupIds': ['OG001'], 'pValueComment': 'A two-sided p-value less than 0.05 was considered statistically significant.', 'groupDescription': 'Within-group change from baseline', 'statisticalMethod': 'Wilcoxon rank sum test', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'From baseline to Day 30 (Part 3)', 'description': 'Conjunctival redness score is assessed on an ordinal scale of 0 to 4 (IER grading scale):\n\n0 = not existing, 1 = very slight, 2 = slight, 3 = moderate, 4 = severe. Higher score represents more intense redness.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety dataset'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change From Baseline Lid Redness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Emulsion Eye Drops', 'description': 'Daily treatment with Piiloset Trehalose Emulsion Eye Drops\n\nResults are reported for Part 3 only:\n\nTopical application of preservative-free multidose Piiloset Trehalose Emulsion Eye Drops on both eyes 3 times a day for 30 days'}, {'id': 'OG001', 'title': 'Control Eye Drops', 'description': 'Daily treatment with Hyaluronic Acid Eye Drops (a CE-marked medical device)\n\nResults are reported for Part 3 only:\n\nTopical application of preservative-free multidose Hyaluronic Acid Eye Drops on both eyes 3 times a day for 30 days'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.37', 'spread': '0.672', 'groupId': 'OG000'}, {'value': '-0.19', 'spread': '0.549', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.296', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Wilcoxon Z statistic', 'ciNumSides': 'TWO_SIDED', 'paramValue': '1.0440', 'pValueComment': 'A two-sided p-value less than 0.05 was considered statistically significant.', 'groupDescription': 'Between-group comparison, change from baseline', 'statisticalMethod': 'Wilcoxon rank sum test', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.012', 'groupIds': ['OG000'], 'pValueComment': 'A two-sided p-value less than 0.05 was considered statistically significant.', 'groupDescription': 'Within-group change from baseline', 'statisticalMethod': 'Wilcoxon rank sum test', 'nonInferiorityType': 'OTHER'}, {'pValue': '>0.05', 'groupIds': ['OG001'], 'pValueComment': 'A two-sided p-value less than 0.05 was considered statistically significant.', 'groupDescription': 'Within-group change from baseline', 'statisticalMethod': 'Wilcoxon rank sum test', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'From baseline to Day 30 (Part 3)', 'description': 'Eyelid redness score is assessed on an ordinal scale of 0 to 4 (IER grading scale):\n\n0 = not existing, 1 = very slight, 2 = slight, 3 = moderate, 4 = severe. Higher score represents more intense redness.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety dataset'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change From Baseline Intraocular Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Emulsion Eye Drops', 'description': 'Daily treatment with Piiloset Trehalose Emulsion Eye Drops\n\nResults are reported for Part 3 only:\n\nTopical application of preservative-free multidose Piiloset Trehalose Emulsion Eye Drops on both eyes 3 times a day for 30 days'}, {'id': 'OG001', 'title': 'Control Eye Drops', 'description': 'Daily treatment with Hyaluronic Acid Eye Drops (a CE-marked medical device)\n\nResults are reported for Part 3 only:\n\nTopical application of preservative-free multidose Hyaluronic Acid Eye Drops on both eyes 3 times a day for 30 days'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.12', 'spread': '1.705', 'groupId': 'OG000'}, {'value': '-0.42', 'spread': '1.653', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From baseline to Day 30 (Part 3)', 'description': 'Intraocular pressure measured using Goldmann applanation tonometry (mmHg)', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety dataset'}, {'type': 'POST_HOC', 'title': 'Change From Baseline Tear Osmolarity in Hyperosmolar Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Emulsion Eye Drops', 'description': 'Daily treatment with Piiloset Trehalose Emulsion Eye Drops\n\nResults are reported for Part 3 only:\n\nTopical application of preservative-free multidose Piiloset Trehalose Emulsion Eye Drops on both eyes 3 times a day for 30 days'}, {'id': 'OG001', 'title': 'Control Eye Drops', 'description': 'Daily treatment with Hyaluronic Acid Eye Drops (a CE-marked medical device)\n\nResults are reported for Part 3 only:\n\nTopical application of preservative-free multidose Hyaluronic Acid Eye Drops on both eyes 3 times a day for 30 days'}], 'classes': [{'categories': [{'measurements': [{'value': '-17.06', 'spread': '10.425', 'groupId': 'OG000'}, {'value': '-15.07', 'spread': '16.596', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.764', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.9911', 'ciLowerLimit': '-15.6117', 'ciUpperLimit': '11.6295', 'pValueComment': 'A two-sided p-value less than 0.05 was considered statistically significant.', 'groupDescription': 'Between-group comparison, change from baseline', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.0038', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-17.0625', 'ciLowerLimit': '-27.9280', 'ciUpperLimit': '-6.1970', 'pValueComment': 'A two-sided p-value less than 0.05 was considered statistically significant.', 'groupDescription': 'Within-group change from baseline', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.0011', 'groupIds': ['OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-15.0714', 'ciLowerLimit': '-23.2850', 'ciUpperLimit': '-6.8579', 'pValueComment': 'A two-sided p-value less than 0.05 was considered statistically significant.', 'groupDescription': 'Within-group change from baseline', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'From baseline to Day 30 (Part 3)', 'description': 'Instrumental assay of tear fluid osmolarity (mOsm/L) in a hyperosmolar subgroup of participants (mean of eyes ≥308 mOsm/L)', 'unitOfMeasure': 'mOsm/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population with hyperosmolar tears (mean of eyes ≥308 mOsm/L)'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Emulsion Eye Drops', 'description': 'Daily treatment with Piiloset Trehalose Emulsion Eye Drops\n\nPiiloset Trehalose Emulsion Eye Drops: Topical application of preservative-free multidose Piiloset Trehalose Emulsion Eye Drops\n\n* Part 1: on one eye 4 times during one day\n* Part 2: on one randomized eye 3 times a day for 10 days\n* Part 3: on both eyes 3 times a day for 30 days'}, {'id': 'FG001', 'title': 'Control Eye Drops', 'description': 'Daily treatment with Hyaluronic Acid Eye Drops (a CE-marked medical device)\n\nControl Eye Drops: Topical application of preservative-free multidose Hyaluronic Acid Eye Drops\n\n* Part 1: not used\n* Part 2: on randomized contralateral eye 3 times a day for 10 days\n* Part 3: on both eyes 3 times a day for 30 days'}], 'periods': [{'title': 'Part 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Emulsion Eye Drops were used on one eye only.', 'groupId': 'FG000', 'numUnits': '3', 'numSubjects': '3'}, {'comment': 'Control Eye Drops were not used for Part 1.', 'groupId': 'FG001', 'numUnits': '0', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'No participant completing Part 1 was allowed to continue to Parts 2 or 3.', 'groupId': 'FG000', 'numUnits': '3', 'numSubjects': '3'}, {'groupId': 'FG001', 'numUnits': '0', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG001', 'numUnits': '0', 'numSubjects': '0'}]}]}, {'title': 'Part 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Emulsion Eye Drops were used on one randomized eye. Participants were different from Part 1.', 'groupId': 'FG000', 'numUnits': '9', 'numSubjects': '9'}, {'comment': 'Control Eye Drops were used on contralateral eye. Participants were different from Part 1.', 'groupId': 'FG001', 'numUnits': '9', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'No participant completing Part 2 was allowed to continue to Part 3.', 'groupId': 'FG000', 'numUnits': '9', 'numSubjects': '9'}, {'comment': 'No participant completing Part 2 was allowed to continue to Part 3.', 'groupId': 'FG001', 'numUnits': '9', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG001', 'numUnits': '0', 'numSubjects': '0'}]}]}, {'title': 'Part 3', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Emulsion Eye Drops were used on both eyes. Participants were different from Parts 1 and 2.', 'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '26'}, {'comment': 'Control Eye Drops were used on both eyes. Participants were different from Parts 1 and 2.', 'groupId': 'FG001', 'numUnits': '0', 'numSubjects': '26'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': "Per-protocol (PP) dataset. 'Not Completed' participants are included in safety and ITT datasets.", 'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '24'}, {'comment': "Per-protocol (PP) dataset. 'Not Completed' participants are included in safety and ITT datasets.", 'groupId': 'FG001', 'numUnits': '0', 'numSubjects': '25'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '2'}, {'groupId': 'FG001', 'numUnits': '0', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'typeUnitsAnalyzed': 'Eyes', 'recruitmentDetails': 'The study comprised three sequential parts. Parts 1 to 3 involved different participants each, thus no participant flow between parts (or periods) took place.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Emulsion Eye Drops', 'description': 'Daily treatment with Piiloset Trehalose Emulsion Eye Drops\n\nResults are reported for Part 3 only:\n\nTopical application of preservative-free multidose Piiloset Trehalose Emulsion Eye Drops on both eyes 3 times a day for 30 days'}, {'id': 'BG001', 'title': 'Control Eye Drops', 'description': 'Daily treatment with Hyaluronic Acid Eye Drops (a CE-marked medical device)\n\nResults are reported for Part 3 only:\n\nTopical application of preservative-free multidose Hyaluronic Acid Eye Drops on both eyes 3 times a day for 30 days'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '55.1', 'spread': '13.8', 'groupId': 'BG000'}, {'value': '51.5', 'spread': '11.4', 'groupId': 'BG001'}, {'value': '53.3', 'spread': '12.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '16', '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': 'Finland', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Body Weight', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '75.1', 'spread': '11.7', 'groupId': 'BG000'}, {'value': '76.9', 'spread': '15.8', 'groupId': 'BG001'}, {'value': '76.0', 'spread': '13.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Ocular Surface Disease Index (OSDI)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '48.1', 'spread': '10.8', 'groupId': 'BG000'}, {'value': '45.6', 'spread': '11.3', 'groupId': 'BG001'}, {'value': '46.9', 'spread': '11.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Ocular Surface Disease Index (OSDI) is a questionnaire consisting of 12 questions subdivided into 3 subscales for measuring the frequency of dry eye symptoms, vision-related quality of life and environmental triggers during the previous week. Answers to each question are on a scale of 0 (None of the time) to 4 (All of the time). Both total OSDI and its subscale scores are on a scale of 0 to 100, calculated as follows: score = (sum of scores for questions answered/number of questions answered) x 25. Higher scores represent greater disability.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Tear Break-Up Time (TBUT)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '3.35', 'spread': '2.62', 'groupId': 'BG000'}, {'value': '3.46', 'spread': '2.04', 'groupId': 'BG001'}, {'value': '3.40', 'spread': '2.33', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 's', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Tear osmolarity', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '304.0', 'spread': '11.8', 'groupId': 'BG000'}, {'value': '307.3', 'spread': '12.4', 'groupId': 'BG001'}, {'value': '305.6', 'spread': '12.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mOsm/L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Blink rate', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '18.17', 'spread': '11.49', 'groupId': 'BG000'}, {'value': '22.27', 'spread': '12.93', 'groupId': 'BG001'}, {'value': '20.22', 'spread': '12.28', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Measurement of spontaneous eyelid blinks per minute', 'unitOfMeasure': 'Blinks/min', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Ocular protection index (OPI)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0.98', 'spread': '0.937', 'groupId': 'BG000'}, {'value': '1.23', 'spread': '1.188', 'groupId': 'BG001'}, {'value': '1.11', 'spread': '1.067', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Ocular protection index (OPI) is the ratio of TBUT/IBI (IBI, interblink interval calculated from blink rate). An OPI value \\>1 indicates that TBUT (s) exceeds IBI (s) and that the ocular surface is mostly tear-film protected, because tear film break-ups do not take place within spontaneous blink cycles.', 'unitOfMeasure': 'ratio', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Corneal staining', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1.37', 'spread': '0.794', 'groupId': 'BG000'}, {'value': '1.21', 'spread': '0.603', 'groupId': 'BG001'}, {'value': '1.29', 'spread': '0.703', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Corneal staining score is assessed as the average number of punctate dots on an ordinal scale of 0, 1, 2, 3, 4, and 5 (Oxford scale) when compared to a pictorial standard. The number of dots increases on a log scale. Higher score represents more intense staining.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Conjunctival staining (temporal)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1.06', 'spread': '0.432', 'groupId': 'BG000'}, {'value': '1.06', 'spread': '0.497', 'groupId': 'BG001'}, {'value': '1.06', 'spread': '0.461', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Conjunctival staining score is assessed as the average number of punctate dots on an ordinal scale of 0, 1, 2, 3, 4, and 5 (Oxford scale) when compared to a pictorial standard. The number of dots increases on a log scale. Higher score represents more intense staining.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Conjunctival staining (nasal)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1.23', 'spread': '0.430', 'groupId': 'BG000'}, {'value': '1.23', 'spread': '0.406', 'groupId': 'BG001'}, {'value': '1.23', 'spread': '0.414', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Conjunctival staining score is assessed as the average number of punctate dots on an ordinal scale of 0, 1, 2, 3, 4, and 5 (Oxford scale) when compared to a pictorial standard. The number of dots increases on a log scale. Higher score represents more intense staining.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Conjunctival redness', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1.98', 'spread': '0.685', 'groupId': 'BG000'}, {'value': '1.94', 'spread': '0.829', 'groupId': 'BG001'}, {'value': '1.96', 'spread': '0.753', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Conjunctival redness score is assessed on an ordinal scale of 0 to 4 (Institute for Eye Research (IER) grading scale):\n\n0 = not existing, 1 = very slight, 2 = slight, 3 = moderate, 4 = severe. Higher score represents more intense redness.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Lid redness', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1.29', 'spread': '0.751', 'groupId': 'BG000'}, {'value': '1.29', 'spread': '0.724', 'groupId': 'BG001'}, {'value': '1.29', 'spread': '0.730', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Eyelid redness score is assessed on an ordinal scale of 0 to 4 (Institute for Eye Research (IER) grading scale):\n\n0 = not existing, 1 = very slight, 2 = slight, 3 = moderate, 4 = severe. Higher score represents more intense redness.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Intraocular pressure', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '14.92', 'spread': '2.134', 'groupId': 'BG000'}, {'value': '15.69', 'spread': '2.558', 'groupId': 'BG001'}, {'value': '15.31', 'spread': '2.364', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmHg (Goldmann tonometer)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Ocular surgery, trauma, refractive laser vision correction', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Eye infection', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Allergy', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Current or planned pregnancy and nursing', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Part 3: 52 eyes of 26 pts treated with Emulsion Eye Drops and 52 eyes of 26 pts treated with Control Eye Drops.\n\nResults are reported for Part 3 only.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-04-06', 'size': 596077, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-11-20T07:30', 'hasProtocol': True}, {'date': '2018-12-06', 'size': 371821, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2019-11-20T07:54', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Part 1. Piiloset Trehalose Emulsion Eye Drop is administered on the worst eye four times during office hours of one day at the study centre.\n\nPart 2. Piiloset Trehalose Emulsion Eye Drop is self-administered on a randomized eye and the control eye drops on the contralateral eye three times a day for 10 days in a double-blinded fashion.\n\nPart 3. Either Piiloset Trehalose Emulsion Eye Drop or the control eye drops are self-administered on both eyes three times a day for 30 days in a randomized and double-blinded fashion.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-05-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2018-11-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-11-22', 'studyFirstSubmitDate': '2018-04-24', 'resultsFirstSubmitDate': '2019-10-11', 'studyFirstSubmitQcDate': '2018-06-14', 'lastUpdatePostDateStruct': {'date': '2019-12-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-11-22', 'studyFirstPostDateStruct': {'date': '2018-06-26', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2019-12-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-11-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change From Baseline Visual Acuity', 'timeFrame': 'From baseline to Day 30 (Part 3)', 'description': 'Best corrected visual acuity (ETDRS charts 1 \\& 2, 2000 series)'}, {'measure': 'Change From Baseline Conjunctival Redness', 'timeFrame': 'From baseline to Day 30 (Part 3)', 'description': 'Conjunctival redness score is assessed on an ordinal scale of 0 to 4 (IER grading scale):\n\n0 = not existing, 1 = very slight, 2 = slight, 3 = moderate, 4 = severe. Higher score represents more intense redness.'}, {'measure': 'Change From Baseline Lid Redness', 'timeFrame': 'From baseline to Day 30 (Part 3)', 'description': 'Eyelid redness score is assessed on an ordinal scale of 0 to 4 (IER grading scale):\n\n0 = not existing, 1 = very slight, 2 = slight, 3 = moderate, 4 = severe. Higher score represents more intense redness.'}, {'measure': 'Change From Baseline Intraocular Pressure', 'timeFrame': 'From baseline to Day 30 (Part 3)', 'description': 'Intraocular pressure measured using Goldmann applanation tonometry (mmHg)'}], 'primaryOutcomes': [{'measure': 'Change From Baseline OSDI', 'timeFrame': 'From baseline to Day 30 (Part 3)', 'description': 'Ocular Surface Disease Index (OSDI) is a questionnaire consisting of 12 questions subdivided into 3 subscales for measuring the frequency of dry eye symptoms, vision-related quality of life and environmental triggers during the previous week. Answers to each question are on a scale of 0 (None of the time) to 4 (All of the time). Both total OSDI and its subscale scores are on a scale of 0 to 100, calculated as follows: score = (sum of scores for questions answered/number of questions answered) x 25. Higher scores represent greater disability.'}, {'measure': 'Change From Baseline Tear Osmolarity', 'timeFrame': 'From baseline to Day 30 (Part 3)', 'description': 'Instrumental assay of tear fluid osmolarity (mOsm/L)'}, {'measure': 'Change From Baseline TBUT', 'timeFrame': 'From baseline to Day 30 (Part 3)', 'description': 'Tear film break-up time (TBUT) (s)'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline Blink Rate', 'timeFrame': 'From baseline to Day 30 (Part 3)', 'description': 'Measurement of spontaneous eyelid blinks per minute'}, {'measure': 'Change From Baseline Ocular Protection Index (OPI)', 'timeFrame': 'From baseline to Day 30 (Part 3)', 'description': 'OPI is the ratio of TBUT/IBI (IBI, interblink interval calculated from blink rate). An OPI value \\>1 indicates that TBUT (s) exceeds IBI (s) and that the ocular surface is mostly tear-film protected, because tear film break-ups do not take place within spontaneous blink cycles.'}, {'measure': 'Change From Baseline Corneal Staining', 'timeFrame': 'From baseline to Day 30 (Part 3)', 'description': 'Corneal staining score is assessed as the average number of punctate dots on an ordinal scale of 0, 1, 2, 3, 4, and 5 (Oxford scale) when compared to a pictorial standard. The number of dots increases on a log scale. Higher score represents more intense staining.'}, {'measure': 'Change From Baseline Conjunctival (Temporal) Staining', 'timeFrame': 'From baseline to Day 30 (Part 3)', 'description': 'Conjunctival staining score is assessed as the average number of punctate dots on an ordinal scale of 0, 1, 2, 3, 4, and 5 (Oxford scale) when compared to a pictorial standard. The number of dots increases on a log scale. Higher score represents more intense staining.'}, {'measure': 'Change From Baseline Conjunctival (Nasal) Staining', 'timeFrame': 'From baseline to Day 30 (Part 3)', 'description': 'Conjunctival staining score is assessed as the average number of punctate dots on an ordinal scale of 0, 1, 2, 3, 4, and 5 (Oxford scale) when compared to a pictorial standard. The number of dots increases on a log scale. Higher score represents more intense staining.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Lubricant Eye Drops', 'Moderate or Severe Dry Eye', 'Hyaluronic Acid', 'Trehalose', 'Disaccharides', 'Polysaccharides', 'Fatty Acids, Omega-3', 'Tears', 'Osmolar Concentration', 'Anterior Eye Segment', 'Severity of Illness Index'], 'conditions': ['Dry Eye Syndrome']}, 'referencesModule': {'references': [{'pmid': '31579987', 'type': 'RESULT', 'citation': 'Laihia J, Jarvinen R, Wylegala E, Kaarniranta K. Disease aetiology-based design of multifunctional microemulsion eye drops for moderate or severe dry eye: a randomized, quadruple-masked and active-controlled clinical trial. Acta Ophthalmol. 2020 May;98(3):244-254. doi: 10.1111/aos.14252. Epub 2019 Oct 3.'}]}, 'descriptionModule': {'briefSummary': 'The study evaluates the safety, ocular tolerability and efficacy of emulsion eye drops with sacha inchi seed oil, trehalose and hyaluronic acid in the treatment of moderate or severe dry eye in adult patients. The investigative device is studied in comparison with control eye drops containing hyaluronic acid for up to 30 days.', 'detailedDescription': 'According to the current view on dry eye disease, tear film instability, tear film hyperosmolarity, and ocular surface inflammation and damage are identified as etiological factors. The first-line medicinal management options include ocular lubricants such as eye drops and sprays. Emulsion eye drops are a relatively recent entity among topical therapies with an intention to account for deficiencies in the outermost lipid layer of the tear film.\n\nPiiloset Trehalose Emulsion Eye Drops was developed to target and restore the three main layers (mucin, aqueous, and lipid) of the tear film and to counteract the key etiological factors leading to dry eye. Hyaluronic acid and the oil component are intended to restore tear film instability, the hypo-osmolar composition and trehalose as an osmoprotectant are intended to protect the ocular epithelium against hyperosmolarity, and ocular surface inflammation and cellular damage are prevented by the cytoprotective and/or anti-oxidative action of hyaluronic acid, trehalose, and sacha inchi oil components. Additional water binding in the tear film is provided by hyaluronic acid, trehalose, and glycerol. Lubricating the ocular surface by high-molecular-weight hyaluronic acid will extend the precorneal retention time. Adjustments made to certain physical and chemical parameters in the formulation are anticipated to improve tear film spreading and adhesion. The optically clear o/w emulsion formulation is free of preservatives, materials of animal origin, phosphates, or alcohol. The combined action of the individual components is expected to produce clinically relevant mitigation of the signs and symptoms of dry eye.\n\nThe study comprises three Parts with scheduled visits on Day 1 (all Parts) and on end-of-study date (Parts 2 and 3) to the study centre. Each study subject will participate in no more than one Part of the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Ability and willingness to give informed written consent prior to any screening procedure after explanation of the nature and possible consequences of the study.\n2. Age between 18 and 80 years.\n3. At least two the following conditions (A and B):\n\n A. Symptomatic dry eye with OSDI score ≥20. AND B1. Tear film break-up time (TBUT) \\<10 seconds. OR B2. Positive ocular (corneal and conjunctival) staining pattern\n4. Body weight at least 45 kg.\n5. Under stable topical and/or systemic therapy for at least 4 weeks before the study procedures and apparent ability and willingness to abstain from other therapies until completion of the study period.\n6. Ability and willingness to self-administer eye drops.\n7. Ability and willingness to understand and fill in the OSDI questionnaire.\n8. Ability and willingness to comply with the study protocol and other study-related procedures.\n\nExclusion Criteria:\n\n1. History of ocular surgery, trauma, or refractive laser vision correction procedure less than 3 months earlier.\n2. Evidence of acute or chronic infection in the cornea or conjunctiva.\n3. Diagnosis of Sjögren's syndrome.\n4. Unwillingness or apparent disability to discontinue contact lens use during study period and at least one week before the first dosing day.\n5. Current ocular allergy symptoms.\n6. Known allergy to any constituent of the trehalose emulsion eye drops or control eye drops.\n7. Currently pregnant, nursing or planning to become pregnant before completion of the study period.\n8. Any other condition that may, in the Investigator's opinion, jeopardize the safety or availability of the subject or adherence to the study protocol or may interfere with the interpretation of the results and would thus make the subject inappropriate for entry in the study."}, 'identificationModule': {'nctId': 'NCT03569202', 'briefTitle': 'Piiloset Trehalose Emulsion Eye Drop Study in Moderate or Severe Dry Eye', 'organization': {'class': 'OTHER', 'fullName': 'Kuopio University Hospital'}, 'officialTitle': 'A Randomized, Active-controlled, Parallel, Double-blind Study on the Safety, Ocular Tolerability and Efficacy of Piiloset Trehalose Emulsion Eye Drop in Adult Patients With Moderate or Severe Dry Eye', 'orgStudyIdInfo': {'id': '5503762'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Emulsion Eye Drops', 'description': 'Daily treatment with Piiloset Trehalose Emulsion Eye Drops', 'interventionNames': ['Device: Piiloset Trehalose Emulsion Eye Drops']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control Eye Drops', 'description': 'Daily treatment with Hyaluronic Acid Eye Drops (a CE-marked medical device)', 'interventionNames': ['Device: Control Eye Drops']}], 'interventions': [{'name': 'Piiloset Trehalose Emulsion Eye Drops', 'type': 'DEVICE', 'description': 'Topical application of preservative-free multidose Piiloset Trehalose Emulsion Eye Drops 3 times daily', 'armGroupLabels': ['Emulsion Eye Drops']}, {'name': 'Control Eye Drops', 'type': 'DEVICE', 'description': 'Topical application of preservative-free multidose Hyaluronic Acid Eye Drops 3 times daily', 'armGroupLabels': ['Control Eye Drops']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'FI-70200', 'city': 'Kuopio', 'country': 'Finland', 'facility': 'Department of Ophthalmology, Kuopio University Hospital', 'geoPoint': {'lat': 62.89238, 'lon': 27.67703}}], 'overallOfficials': [{'name': 'Kai Kaarniranta, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kuopio University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kuopio University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Finnsusp Ltd.', 'class': 'INDUSTRY'}, {'name': '4Pharma Ltd.', 'class': 'INDUSTRY'}, {'name': 'Business Finland', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD, Professor', 'investigatorFullName': 'Kai Kaarniranta', 'investigatorAffiliation': 'Kuopio University Hospital'}}}}