Ignite Creation Date:
2025-12-24 @ 7:56 PM
Ignite Modification Date:
2026-03-30 @ 1:40 PM
Study NCT ID:
NCT04281004
Status:
COMPLETED
Last Update Posted:
2024-04-18
First Post:
2020-02-19
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Processed Amniotic Fluid (PAF) Drops After Photorefractive Keratectomy (PRK)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-02-07', 'type': 'ACTUAL'}}}}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mark.mifflin@hsc.utah.edu', 'phone': '801-583-4152', 'title': 'Mark Mifflin, MD', 'organization': 'University of Utah'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'The limitations of this study include small sample size and limited duration for follow-up. A larger sample size may reveal whether pAF has a protective effect against haze formation, as haze after PRK is rare. Longer duration of follow-up can reveal whether it influences final visual acuity outcomes or late haze formation.'}}, 'adverseEventsModule': {'timeFrame': 'Randomization through last study visit (12 months after the last study dose), up to 56 weeks.', 'description': 'All deaths, Serious Adverse Events, and other ocular Adverse Events regardless of seriousness were reported.', 'eventGroups': [{'id': 'EG000', 'title': 'Amniotic Fluid (AFED)', 'description': 'Amniotic Fluid (AFED): One drop (0.25 mL) of Amniotic Fluid Eye Drops (AFED) in each eye four times daily for seven days', 'otherNumAtRisk': 28, 'deathsNumAtRisk': 28, 'otherNumAffected': 2, 'seriousNumAtRisk': 28, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Saline Solution', 'description': 'Saline Solution: One drop (0.25 mL) of Saline Solution in each eye four times daily for seven days', 'otherNumAtRisk': 32, 'deathsNumAtRisk': 32, 'otherNumAffected': 1, 'seriousNumAtRisk': 32, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Intraocular pressure increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.1)'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.1)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Safety - Adverse Events Including Serious Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Amniotic Fluid (AFED)', 'description': 'Amniotic Fluid (AFED): One drop (0.25 mL) of Amniotic Fluid Eye Drops (AFED) in each eye four times daily for seven days'}, {'id': 'OG001', 'title': 'Saline Solution', 'description': 'Saline Solution: One drop (0.25 mL) of Saline Solution in each eye four times daily for seven days'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '1.000', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 12 months after the last study dose', 'description': 'Ocular adverse events using MedDRA and CTCAE and serious adverse events', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time to Complete Re-epithelization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Amniotic Fluid (AFED)', 'description': 'Amniotic Fluid (AFED): One drop (0.25 mL) of Amniotic Fluid Eye Drops (AFED) in each eye four times daily for seven days'}, {'id': 'OG001', 'title': 'Saline Solution', 'description': 'Saline Solution: One drop (0.25 mL) of Saline Solution in each eye four times daily for seven days'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '5', 'spread': '0.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.869', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Mixed model analysis is used to account for correlation between eyes in the same participant.'}], 'paramType': 'MEAN', 'timeFrame': 'Post-operative days 1 - 8', 'description': 'Ophthalmologic assessment to determine re-epithelialization. Dimensions of the epithelial defects will be directly measured using slit lamp bio-microscopy. The baseline epithelial defect will be measured by surgeons on Day 1 at the time of surgery. A vertical and horizontal measure of defect in mm will be performed, and defect area calculated. A complete re-epithelization (absence of a defect) is defined when the measures equal zero.', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Uncorrected Visual Acuity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}, {'units': 'eyes', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Amniotic Fluid (AFED)', 'description': 'Amniotic Fluid (AFED): One drop (0.25 mL) of Amniotic Fluid Eye Drops (AFED) in each eye four times daily for seven days'}, {'id': 'OG001', 'title': 'Saline Solution', 'description': 'Saline Solution: One drop (0.25 mL) of Saline Solution in each eye four times daily for seven days'}], 'classes': [{'title': 'Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}, {'units': 'eyes', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.03', 'spread': '0.103', 'groupId': 'OG000'}, {'value': '0.04', 'spread': '0.123', 'groupId': 'OG001'}]}]}, {'title': 'Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}, {'units': 'eyes', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.06', 'spread': '0.097', 'groupId': 'OG000'}, {'value': '-0.05', 'spread': '0.103', 'groupId': 'OG001'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}, {'units': 'eyes', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.07', 'spread': '0.085', 'groupId': 'OG000'}, {'value': '-0.06', 'spread': '0.091', 'groupId': 'OG001'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}, {'units': 'eyes', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.09', 'spread': '0.058', 'groupId': 'OG000'}, {'value': '-0.06', 'spread': '0.107', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.007', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Significance of treatment effect at month 1.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Mixed model analysis is used to account for correlation between eyes in the same participant.'}, {'pValue': '0.953', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Significance of treatment effect at month 3.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Mixed model analysis is used to account for correlation between eyes in the same participant.'}, {'pValue': '0.841', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Significance of treatment effect at month 6.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Mixed model analysis is used to account for correlation between eyes in the same participant.'}, {'pValue': '0.137', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Significance of treatment effect at month 12.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Mixed model analysis is used to account for correlation between eyes in the same participant.'}], 'paramType': 'MEAN', 'timeFrame': 'Post-operative months 1, 3, 6, and 12', 'description': 'Ophthalmologic assessment to determine uncorrected visual acuity', 'unitOfMeasure': 'LogMAR', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'eyes', 'populationDescription': 'Some patients missed one or more follow-up windows. We analyzed all available data.'}, {'type': 'SECONDARY', 'title': 'Pain in Each Eye', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Amniotic Fluid (AFED)', 'description': 'Amniotic Fluid (AFED): One drop (0.25 mL) of Amniotic Fluid Eye Drops (AFED) in each eye four times daily for seven days'}, {'id': 'OG001', 'title': 'Saline Solution', 'description': 'Saline Solution: One drop (0.25 mL) of Saline Solution in each eye four times daily for seven days'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '7'}, {'value': '5', 'groupId': 'OG001', 'lowerLimit': '3', 'upperLimit': '7'}]}]}], 'analyses': [{'pValue': '0.614', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Post-operative days 1 - 8', 'description': 'Patient reported pain using a visual analog scale (VAS) with 0 as no pain and 10 as worst pain', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Count of Participants Who Reported Oral Pain Medication Usage', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Amniotic Fluid (AFED)', 'description': 'Amniotic Fluid (AFED): One drop (0.25 mL) of Amniotic Fluid Eye Drops (AFED) in each eye four times daily for seven days'}, {'id': 'OG001', 'title': 'Saline Solution', 'description': 'Saline Solution: One drop (0.25 mL) of Saline Solution in each eye four times daily for seven days'}], 'classes': [{'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.594', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Post-operative days 1 - 8', 'description': 'Patient reported oral pain medication usage in the first seven days of post-surgical follow-up (yes/no), where yes corresponds to any use of oral pain medication.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Corneal Staining in Each Eye', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}, {'units': 'eyes', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Amniotic Fluid (AFED)', 'description': 'Amniotic Fluid (AFED): One drop (0.25 mL) of Amniotic Fluid Eye Drops (AFED) in each eye four times daily for seven days'}, {'id': 'OG001', 'title': 'Saline Solution', 'description': 'Saline Solution: One drop (0.25 mL) of Saline Solution in each eye four times daily for seven days'}], 'classes': [{'title': 'Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}, {'units': 'eyes', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'categories': [{'title': 'A0D0', 'measurements': [{'value': '33', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}, {'title': 'A1D1', 'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}, {'title': 'A1D2', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}, {'title': 'A1D3', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'A2D2', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'A2D1', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}, {'units': 'eyes', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'categories': [{'title': 'A0D0', 'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}, {'title': 'A1D1', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}, {'title': 'A1D2', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'A1D3', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'A2D2', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'A2D1', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}, {'units': 'eyes', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'categories': [{'title': 'A0D0', 'measurements': [{'value': '46', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}, {'title': 'A1D1', 'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}, {'title': 'A1D2', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'A1D3', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'A2D2', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'A2D1', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}, {'units': 'eyes', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'categories': [{'title': 'A0D0', 'measurements': [{'value': '47', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}, {'title': 'A1D1', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}, {'title': 'A1D2', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'A1D3', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'A2D2', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'A2D1', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.663', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Significance of treatment effect at month 1.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Clustered version of the Wilcoxon test'}, {'pValue': '0.416', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Significance of treatment effect at month 3.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Clustered version of the Wilcoxon test'}, {'pValue': '0.890', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Significance of treatment effect at month 6.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Clustered version of the Wilcoxon test'}, {'pValue': '0.192', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Significance of treatment effect at month 12.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Clustered version of the Wilcoxon test'}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': 'Post-operative months 1, 3, 6, and 12', 'description': 'Ocular surface staining to determine ocular dryness using an area density index with 16 index options. A0D0 equals no dry eye to A3D3 equals most severe dryness (A=area and D=density).', 'unitOfMeasure': 'eyes', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'eyes', 'populationDescription': 'Subjects were analyzed for every follow-up that was collected. Some subject missed one or more follow-ups.'}, {'type': 'SECONDARY', 'title': 'Corneal Surface Regularity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}, {'units': 'eyes', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Amniotic Fluid (AFED)', 'description': 'Amniotic Fluid (AFED): One drop (0.25 mL) of Amniotic Fluid Eye Drops (AFED) in each eye four times daily for seven days'}, {'id': 'OG001', 'title': 'Saline Solution', 'description': 'Saline Solution: One drop (0.25 mL) of Saline Solution in each eye four times daily for seven days'}], 'classes': [{'title': 'Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}, {'units': 'eyes', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.34', 'spread': '0.567', 'groupId': 'OG000'}, {'value': '1.58', 'spread': '0.748', 'groupId': 'OG001'}]}]}, {'title': 'Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}, {'units': 'eyes', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.11', 'spread': '0.616', 'groupId': 'OG000'}, {'value': '1.07', 'spread': '0.407', 'groupId': 'OG001'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}, {'units': 'eyes', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.07', 'spread': '0.376', 'groupId': 'OG000'}, {'value': '0.97', 'spread': '0.389', 'groupId': 'OG001'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}, {'units': 'eyes', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.03', 'spread': '0.459', 'groupId': 'OG000'}, {'value': '1.05', 'spread': '0.661', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.057', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Significance of treatment effect at month 1.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Mixed model analysis is used to account for correlation between eyes in the same participant.'}, {'pValue': '0.528', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Significance of treatment effect at month 3.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Mixed model analysis is used to account for correlation between eyes in the same participant.'}, {'pValue': '0.210', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Significance of treatment effect at month 6.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Mixed model analysis is used to account for correlation between eyes in the same participant.'}, {'pValue': '0.853', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Significance of treatment effect at month 12.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Mixed model analysis is used to account for correlation between eyes in the same participant.'}], 'paramType': 'MEAN', 'timeFrame': 'Post-operative months 1, 3, 6, and 12', 'description': 'Surface Regularity Index (SRI) obtained via Zeiss Atlas 9000 Corneal Topography™. SRI is a measure of central and paracentral corneal irregularity. A lower SRI suggests more regularity of the anterior surface of the central cornea. Lower values are considered better. The minimum value is 0 and no maximum. And, a value less than 1.55 is considered normal.', 'unitOfMeasure': 'Surface regularity index', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'eyes', 'populationDescription': 'Some patients missed one or more follow-up windows. We analyzed all available data.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Amniotic Fluid (AFED)', 'description': 'Amniotic Fluid (AFED): One drop (0.25 mL) of Amniotic Fluid Eye Drops (AFED) in each eye four times daily for seven days'}, {'id': 'FG001', 'title': 'Saline Solution', 'description': 'Saline Solution: One drop (0.25 mL) of Saline Solution in each eye four times daily for seven days'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '58', 'numSubjects': '29'}, {'groupId': 'FG001', 'numUnits': '64', 'numSubjects': '32'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'One patient (two eyes) did not receive treatment due to the patient experiencing syncope during the procedure causing the procedure to be aborted.', 'groupId': 'FG000', 'numUnits': '56', 'numSubjects': '28'}, {'groupId': 'FG001', 'numUnits': '64', 'numSubjects': '32'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '2', 'numSubjects': '1'}, {'groupId': 'FG001', 'numUnits': '0', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'typeUnitsAnalyzed': 'eyes'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Amniotic Fluid (AFED)', 'description': 'Amniotic Fluid (AFED): One drop (0.25 mL) of Amniotic Fluid Eye Drops (AFED) in each eye four times daily for seven days'}, {'id': 'BG001', 'title': 'Saline Solution', 'description': 'Saline Solution: One drop (0.25 mL) of Saline Solution in each eye four times daily for seven days'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '33.8', 'groupId': 'BG000', 'lowerLimit': '27.6', 'upperLimit': '38.8'}, {'value': '32.7', 'groupId': 'BG001', 'lowerLimit': '28.3', 'upperLimit': '36.6'}, {'value': '33.4', 'groupId': 'BG002', 'lowerLimit': '28.1', 'upperLimit': '37.3'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '56', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Current Smoker or exposed to secondhand smoke', 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The population includes all subjects who provide informed consent and who are randomized into the trial and who have analyzable primary outcome data for at least one PRK-treated eye.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-12-01', 'size': 259873, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-11-27T10:57', 'hasProtocol': True}, {'date': '2020-01-09', 'size': 506535, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_003.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-02-14T11:56', 'hasProtocol': False}, {'date': '2022-11-28', 'size': 287093, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_002.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2023-11-27T10:58', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 61}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-07-10', 'type': 'ACTUAL'}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2023-01-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-17', 'studyFirstSubmitDate': '2020-02-19', 'resultsFirstSubmitDate': '2024-01-12', 'studyFirstSubmitQcDate': '2020-02-19', 'lastUpdatePostDateStruct': {'date': '2024-04-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-04-17', 'studyFirstPostDateStruct': {'date': '2020-02-21', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-04-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety - Adverse Events Including Serious Adverse Events', 'timeFrame': 'Up to 12 months after the last study dose', 'description': 'Ocular adverse events using MedDRA and CTCAE and serious adverse events'}], 'secondaryOutcomes': [{'measure': 'Time to Complete Re-epithelization', 'timeFrame': 'Post-operative days 1 - 8', 'description': 'Ophthalmologic assessment to determine re-epithelialization. Dimensions of the epithelial defects will be directly measured using slit lamp bio-microscopy. The baseline epithelial defect will be measured by surgeons on Day 1 at the time of surgery. A vertical and horizontal measure of defect in mm will be performed, and defect area calculated. A complete re-epithelization (absence of a defect) is defined when the measures equal zero.'}, {'measure': 'Uncorrected Visual Acuity', 'timeFrame': 'Post-operative months 1, 3, 6, and 12', 'description': 'Ophthalmologic assessment to determine uncorrected visual acuity'}, {'measure': 'Pain in Each Eye', 'timeFrame': 'Post-operative days 1 - 8', 'description': 'Patient reported pain using a visual analog scale (VAS) with 0 as no pain and 10 as worst pain'}, {'measure': 'Count of Participants Who Reported Oral Pain Medication Usage', 'timeFrame': 'Post-operative days 1 - 8', 'description': 'Patient reported oral pain medication usage in the first seven days of post-surgical follow-up (yes/no), where yes corresponds to any use of oral pain medication.'}, {'measure': 'Corneal Staining in Each Eye', 'timeFrame': 'Post-operative months 1, 3, 6, and 12', 'description': 'Ocular surface staining to determine ocular dryness using an area density index with 16 index options. A0D0 equals no dry eye to A3D3 equals most severe dryness (A=area and D=density).'}, {'measure': 'Corneal Surface Regularity', 'timeFrame': 'Post-operative months 1, 3, 6, and 12', 'description': 'Surface Regularity Index (SRI) obtained via Zeiss Atlas 9000 Corneal Topography™. SRI is a measure of central and paracentral corneal irregularity. A lower SRI suggests more regularity of the anterior surface of the central cornea. Lower values are considered better. The minimum value is 0 and no maximum. And, a value less than 1.55 is considered normal.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Photorefractive Keratectomy']}, 'descriptionModule': {'briefSummary': 'This is a randomized, double-masked, placebo-controlled study to determine the safety of pAF in patients who undergo PRK.', 'detailedDescription': 'Photorefractive Keratectomy (PRK) is a common elective surgery used to correct refractive errors. We propose that amniotic fluid drops may be beneficial in promoting ocular surface healing following PRK. Purified amniotic fluid (pAF) contains anti-inflammatory, anti-microbial and regenerative factors similar to solid amniotic membrane. Individual patients will be randomized to one of two post-operative drop regimens, control eyes that will receive placebo saline solution (NaCl 0.9%, Baxter Medical), and study eyes that will receive pAF four times daily for seven days.\n\nThis is a randomized, double-masked, placebo-controlled study to determine\n\n* the safety of pAF in patients who undergo PRK\n* if pAF hastens re-epithelialization following PRK compared to placebo\n* if pAF reduces post-operative pain following PRK compared to placebo\n* if pAF affects visual outcome following PRK compared to placebo\n* if pAF affects ocular surface staining and corneal regularity following PRK compared to placebo'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion:\n\n1. Patients aged 21 years and older.\n2. Patients undergoing PRK for visual correction in both eyes.\n3. Willing and able to give consent for study participation and comply with study procedures, including follow-up visits.\n\nExclusion:\n\n1. Patients with any active eye disease, including keratoconus or any other ectactic disorders.\n2. Patients with documented uncontrolled diabetes.\n3. Patients with severe dry eye as measured by corneal staining.\n4. Patients with calculated PRK treatment resulting in residual stromal bed \\<300 um.\n5. Patients who have had previous eye surgery or refractive laser procedures.\n6. Patients with any active collagen vascular disease.\n7. Patients who do not have potential of 20/20 or better best corrected vision in each eye.'}, 'identificationModule': {'nctId': 'NCT04281004', 'briefTitle': 'Processed Amniotic Fluid (PAF) Drops After Photorefractive Keratectomy (PRK)', 'organization': {'class': 'OTHER', 'fullName': 'University of Utah'}, 'officialTitle': 'A Phase I/II Randomized, Double-Masked Placebo-Controlled Study For Determining The Safety Of Processed Amniotic Fluid (PAF) Drops After Photorefractive Keratectomy', 'orgStudyIdInfo': {'id': '99569'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Amniotic Fluid (AFED)', 'interventionNames': ['Biological: Amniotic Fluid (AFED)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Saline Solution', 'interventionNames': ['Other: Saline Solution']}], 'interventions': [{'name': 'Amniotic Fluid (AFED)', 'type': 'BIOLOGICAL', 'description': 'One drop (0.25 mL) of Amniotic Fluid Eye Drops (AFED) in each eye four times daily for seven days', 'armGroupLabels': ['Amniotic Fluid (AFED)']}, {'name': 'Saline Solution', 'type': 'OTHER', 'description': 'One drop (0.25 mL) of Saline Solution in each eye four times daily for seven days', 'armGroupLabels': ['Saline Solution']}]}, 'contactsLocationsModule': {'locations': [{'zip': '84132', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'Moran Eye Center, University of Utah', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Utah', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Mark Mifflin', 'investigatorAffiliation': 'University of Utah'}}}}