Ignite Creation Date:
2025-12-25 @ 3:29 AM
Ignite Modification Date:
2025-12-26 @ 2:10 AM
Study NCT ID:
NCT03417505
Status:
COMPLETED
Last Update Posted:
2020-01-18
First Post:
2018-01-10
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Tangible Hydra-PEG: A Promising Solution for Scleral Lens Wearers With Dry Eye
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015352', 'term': 'Dry Eye Syndromes'}], 'ancestors': [{'id': 'D007766', 'term': 'Lacrimal Apparatus Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'kelly@tangiblescience.com', 'phone': '650-241-1045', 'title': 'Dr. Kelly Mabry', 'phoneExt': '108', 'organization': 'Tangible Science'}, 'certainAgreement': {'otherDetails': 'The PI has the right to publish results from the study. The Sponsor has 30 days to review communications prior to publication with respect to the disclosure of confidential information (study results would not qualify as confidential information).', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data were collected throughout the period of the study (a period of 79 days for each participant).', 'eventGroups': [{'id': 'EG000', 'title': 'Hydra-PEG Treated Lenses Followed by Untreated Lenses', 'description': 'Participants wore Hydra-PEG lenses for 30 days, followed by a 7 day washout period and then 30 days wearing untreated lenses.', 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 0, 'seriousNumAtRisk': 9, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Untreated Lenses Followed by Hydra-PEG Treated Lenses', 'description': 'Participants wore untreated lenses for 30 days, followed by a 7 day washout period and then 30 days wearing Hydra-PEG treated lenses.', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 0, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Ocular Surface Tear Breakup Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Hydra-PEG Treated Lens Wearers', 'description': 'Patients wearing the Hydra-PEG treated lenses'}, {'id': 'OG001', 'title': 'Untreated Lens Wearers', 'description': 'Patients wearing lenses without the Hydra-PEG treatment'}], 'classes': [{'categories': [{'measurements': [{'value': '3.81', 'spread': '2.63', 'groupId': 'OG000'}, {'value': '2.91', 'spread': '2.14', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.01', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Paired t-test comparison'}], 'paramType': 'MEAN', 'timeFrame': '30 days', 'description': 'Tear breakup time of the ocular surface after wearing lenses', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Corneal Fluorescein Staining', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Hydra-PEG Treated Lens Wearers', 'description': 'Patients wearing the Hydra-PEG treated lenses'}, {'id': 'OG001', 'title': 'Untreated Lens Wearers', 'description': 'Patients wearing lenses without the Hydra-PEG treatment'}], 'classes': [{'categories': [{'measurements': [{'value': '0.92', 'spread': '0.79', 'groupId': 'OG000'}, {'value': '1.40', 'spread': '1.05', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Calculated p value was \\<0.05.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Wilcoxon signed rank comparisons, one-sided'}], 'paramType': 'MEAN', 'timeFrame': '30 days', 'description': 'Fluorescein staining followed by assessment using the Oxford grading scale (0-5, where 5 indicates the most staining and therefore the most damage to the ocular surface) of the ocular surface after wearing Hydra-PEG treated lenses compared to control lenses', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants'}, {'type': 'PRIMARY', 'title': 'Ocular Surface Disease Index (OSDI) Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Hydra-PEG Treated Lens Wearers', 'description': 'Patients wearing the Hydra-PEG treated lenses'}, {'id': 'OG001', 'title': 'Untreated Lens Wearers', 'description': 'Patients wearing lenses without the Hydra-PEG treatment'}], 'classes': [{'categories': [{'measurements': [{'value': '28.24', 'spread': '12.90', 'groupId': 'OG000'}, {'value': '35.10', 'spread': '17.60', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.01', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'paired 1-sided t-test'}], 'paramType': 'MEAN', 'timeFrame': '30 days', 'description': 'Dry eye questionnaire to assess symptoms after wearing Hydra-PEG treated lenses compared to control lenses. Patients will be scored from 0 (no dry eye disease) to 100 (severe dry eye disease).', 'unitOfMeasure': 'OSDI score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'all participants'}, {'type': 'PRIMARY', 'title': 'Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Hydra-PEG Treated Lens Wearers', 'description': 'Patients wearing the Hydra-PEG treated lenses'}, {'id': 'OG001', 'title': 'Untreated Lens Wearers', 'description': 'Patients wearing lenses without the Hydra-PEG treatment'}], 'classes': [{'categories': [{'measurements': [{'value': '11.89', 'spread': '5.26', 'groupId': 'OG000'}, {'value': '17.30', 'spread': '6.50', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.01', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Wilcoxon signed rank comparison, one sided p value'}], 'paramType': 'MEAN', 'timeFrame': '30 days', 'description': 'Validated dry eye questionnaire to assess symptoms after wearing Hydra-PEG treated lenses compared to control lenses. Scale is from 1 to 37, with higher scores indicating more dry eye symptoms.', 'unitOfMeasure': 'CLDEQ-8 score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'all participants'}, {'type': 'SECONDARY', 'title': 'Tear Breakup Time Over the Surface of the Scleral Lens', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Hydra-PEG Treated Lens Wearers', 'description': 'Patients wearing the Hydra-PEG treated lenses'}, {'id': 'OG001', 'title': 'Untreated Lens Wearers', 'description': 'Patients wearing lenses without the Hydra-PEG treatment'}], 'classes': [{'categories': [{'measurements': [{'value': '5.88', 'spread': '5.17', 'groupId': 'OG000'}, {'value': '4.75', 'spread': '2.82', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '>0.05', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Calculated p value was \\>0.05.', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'paired'}], 'paramType': 'MEAN', 'timeFrame': '30 days', 'description': 'Tear breakup time over the surface of the Hydra-PEG treated scleral lens compared to the control lens', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'all participants'}, {'type': 'SECONDARY', 'title': 'Lid Wiper Epitheliopathy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Hydra-PEG Treated Lens Wearers', 'description': 'Patients wearing the Hydra-PEG treated lenses'}, {'id': 'OG001', 'title': 'Untreated Lens Wearers', 'description': 'Patients wearing lenses without the Hydra-PEG treatment'}], 'classes': [{'categories': [{'measurements': [{'value': '0.89', 'spread': '0.76', 'groupId': 'OG000'}, {'value': '1.41', 'spread': '0.62', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Calculated p value was \\<0.05.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'paired, 1-sided'}], 'paramType': 'MEAN', 'timeFrame': '30 days', 'description': 'Fluorescein and lissamine staining to assess lid wiper epitheliopathy using a grading scale to see if there is a change in the height and width of the staining of the lid wiper area with Hydra-PEG treated lenses compared to untreated control lenses. The lid wiper area is the portion of the marginal conjunctival epithelium of the upper eyelid that wipes the ocular surface or lens during blinking. Epitheliopathy is scored on a scale from 0 (best patient outcome) to 3 (worst patient outcome, more staining) on the basis of the horizontal and vertical extent of lid margin staining.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'all participants analyzed with each lens type'}, {'type': 'SECONDARY', 'title': 'Contact Lens-related Papillary Conjunctivitis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Hydra-PEG Treated Lens Wearers', 'description': 'Patients wearing the Hydra-PEG treated lenses'}, {'id': 'OG001', 'title': 'Untreated Lens Wearers', 'description': 'Patients wearing lenses without the Hydra-PEG treatment'}], 'classes': [{'categories': [{'measurements': [{'value': '0.89', 'spread': '0.66', 'groupId': 'OG000'}, {'value': '1.45', 'spread': '0.51', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.01', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'paired, 1-sided'}], 'paramType': 'MEAN', 'timeFrame': '30 days', 'description': 'Visual inspection for contact lens-related papillary conjunctivitis with scoring by the Efron grading scale for papillary conjunctivitis \\[0 (normal) to 4 (severe)\\] to assess changes after wear of Hydra-PEG treated lenses compared to control lenses.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'all participants were analyzed in each lens type'}, {'type': 'SECONDARY', 'title': 'Temporal Conjunctival Lissamine Green Staining', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Hydra-PEG Treated Lens Wearers', 'description': 'Patients wearing the Hydra-PEG treated lenses'}, {'id': 'OG001', 'title': 'Untreated Lens Wearers', 'description': 'Patients wearing lenses without the Hydra-PEG treatment'}], 'classes': [{'categories': [{'measurements': [{'value': '0.95', 'spread': '0.79', 'groupId': 'OG000'}, {'value': '1.23', 'spread': '1.03', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Calculated p value was \\<0.05.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'paired, 1-sided'}], 'paramType': 'MEAN', 'timeFrame': '30 days', 'description': 'Temporal conjunctival lissamine green staining scored 0 (no staining) to 4 (most staining).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'all participants analyzed in both lens types'}, {'type': 'SECONDARY', 'title': 'Nasal Conjunctival Lissamine Green Staining', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Hydra-PEG Treated Lens Wearers', 'description': 'Patients wearing the Hydra-PEG treated lenses'}, {'id': 'OG001', 'title': 'Untreated Lens Wearers', 'description': 'Patients wearing lenses without the Hydra-PEG treatment'}], 'classes': [{'categories': [{'measurements': [{'value': '0.79', 'spread': '0.71', 'groupId': 'OG000'}, {'value': '1.03', 'spread': '0.98', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '>0.05', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Calculated p value was \\>0.05.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'paired, 1-sided'}], 'paramType': 'MEAN', 'timeFrame': '30 days', 'description': 'Nasal conjunctival lissamine green staining scored from 0 (no staining) to 4 (most staining).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'all participants were analyzed in both lens types'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Hydra-PEG Treated Lenses Followed by Untreated Lenses', 'description': 'Hydra-PEG treated lenses were worn for 30 days, followed a one-week washout period and then 30 days wearing untreated lenses'}, {'id': 'FG001', 'title': 'Untreated Lenses Followed by Hydra-PEG Treated Lenses', 'description': 'Untreated lenses were worn for 30 days, followed a one-week washout period and then 30 days wearing Hydra-PEG treated lenses'}], 'periods': [{'title': 'First Lens Type (30 Days)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}, {'title': 'Washout Period (7 Days)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Second Lens Type (30 Days)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Participants', 'description': 'As this was a crossover study, all participants work both the Hydra-PEG treated and untreated lenses. Therefore, the baseline characteristics were the same for both groups.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '51.8', 'spread': '8', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '16', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}], 'populationDescription': 'All participants wore both the Hydra-PEG treated and untreated lenses in this crossover study, therefore the baseline characteristics are the same for both lens types.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-01-30', 'size': 275324, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-12-20T14:06', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Randomized, double-masked crossover study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2019-01-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-01-07', 'studyFirstSubmitDate': '2018-01-10', 'resultsFirstSubmitDate': '2019-12-20', 'studyFirstSubmitQcDate': '2018-01-24', 'lastUpdatePostDateStruct': {'date': '2020-01-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-01-07', 'studyFirstPostDateStruct': {'date': '2018-01-31', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-01-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-01-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ocular Surface Tear Breakup Time', 'timeFrame': '30 days', 'description': 'Tear breakup time of the ocular surface after wearing lenses'}, {'measure': 'Corneal Fluorescein Staining', 'timeFrame': '30 days', 'description': 'Fluorescein staining followed by assessment using the Oxford grading scale (0-5, where 5 indicates the most staining and therefore the most damage to the ocular surface) of the ocular surface after wearing Hydra-PEG treated lenses compared to control lenses'}, {'measure': 'Ocular Surface Disease Index (OSDI) Questionnaire', 'timeFrame': '30 days', 'description': 'Dry eye questionnaire to assess symptoms after wearing Hydra-PEG treated lenses compared to control lenses. Patients will be scored from 0 (no dry eye disease) to 100 (severe dry eye disease).'}, {'measure': 'Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8)', 'timeFrame': '30 days', 'description': 'Validated dry eye questionnaire to assess symptoms after wearing Hydra-PEG treated lenses compared to control lenses. Scale is from 1 to 37, with higher scores indicating more dry eye symptoms.'}], 'secondaryOutcomes': [{'measure': 'Tear Breakup Time Over the Surface of the Scleral Lens', 'timeFrame': '30 days', 'description': 'Tear breakup time over the surface of the Hydra-PEG treated scleral lens compared to the control lens'}, {'measure': 'Lid Wiper Epitheliopathy', 'timeFrame': '30 days', 'description': 'Fluorescein and lissamine staining to assess lid wiper epitheliopathy using a grading scale to see if there is a change in the height and width of the staining of the lid wiper area with Hydra-PEG treated lenses compared to untreated control lenses. The lid wiper area is the portion of the marginal conjunctival epithelium of the upper eyelid that wipes the ocular surface or lens during blinking. Epitheliopathy is scored on a scale from 0 (best patient outcome) to 3 (worst patient outcome, more staining) on the basis of the horizontal and vertical extent of lid margin staining.'}, {'measure': 'Contact Lens-related Papillary Conjunctivitis', 'timeFrame': '30 days', 'description': 'Visual inspection for contact lens-related papillary conjunctivitis with scoring by the Efron grading scale for papillary conjunctivitis \\[0 (normal) to 4 (severe)\\] to assess changes after wear of Hydra-PEG treated lenses compared to control lenses.'}, {'measure': 'Temporal Conjunctival Lissamine Green Staining', 'timeFrame': '30 days', 'description': 'Temporal conjunctival lissamine green staining scored 0 (no staining) to 4 (most staining).'}, {'measure': 'Nasal Conjunctival Lissamine Green Staining', 'timeFrame': '30 days', 'description': 'Nasal conjunctival lissamine green staining scored from 0 (no staining) to 4 (most staining).'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Contact lens discomfort', 'Scleral lens', 'Tangible Hydra-PEG'], 'conditions': ['Dry Eye', 'Dry Eye Syndromes']}, 'referencesModule': {'references': [{'pmid': '33156128', 'type': 'DERIVED', 'citation': 'Mickles CV, Harthan JS, Barnett M. Assessment of a Novel Lens Surface Treatment for Scleral Lens Wearers With Dry Eye. Eye Contact Lens. 2021 May 1;47(5):308-313. doi: 10.1097/ICL.0000000000000754.'}]}, 'descriptionModule': {'briefSummary': 'Tangible Hydra-PEG is a novel coating technology designed to improve lens wettability, deposit resistance, and tear film breakup time. This is a randomized double masked cross-over study to examine contact lens discomfort and dry eye symptoms with Tangible Hydra-PEG treated scleral lens wear compared to untreated scleral lens wear in the dry eye patient population.', 'detailedDescription': 'Dry eye (DE) is a common complaint of millions of people worldwide with a significant impact on quality of life. For decades, this condition has presented a challenge to eye care professionals as conventional therapies are often ineffective. Recently, scleral lenses have demonstrated to be a promising therapeutic and vision rehabilitative option for dry eye sufferers. Nonetheless, despite the benefits of scleral lenses for dry eye patients, inadequate wettability of scleral lenses with subsequent diminished comfort and visual clarity remains a concern for scleral lens wearers with dry eye.\n\nTangible Hydra-PEG (Tangible Science LLC, Menlo Park, CA, USA) is a novel coating technology designed to improve lens wettability, deposit resistance, and tear film breakup time, ultimately enhancing contact lens comfort. While studies have shown that Tangible Hydra-PEG technology can improve contact lens discomfort (CLD) in soft contact lens and gas permeable lens wearers, to our knowledge, no clinical research investigation has examined the benefits of this new coating on scleral lens wear in dry eye sufferers. As such, the aim of this study is to compare the CLD and DE symptoms of dry eye scleral lens wearers between Tangible Hydra-PEG treated scleral lens wear and untreated scleral lens wear. CLD and DE signs will also be assessed to corroborate our findings.\n\nThis will be the first randomized double masked cross-over study to examine CLD and DE symptoms of Tangible Hydra-PEG treated scleral lens wear compared to untreated scleral lens wear in the dry eye patient population. Tangible Hydra-PEG treated scleral lenses can potentially minimize CLD and DE symptoms, ultimately improving outcomes for patients coping with dry eye disease. This study will provide new information about this innovative technology and help practitioners envisage rehabilitative options which will best optimize the quality of life of this important patient population.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Reduced tear film break up time (TBUT), a sign of dry eye disease and contact lens discomfort\n* Scleral lens wearer (at least 8 hours per day for at least 5 days per week and have had their habitual lenses no longer than 1 year). Scleral lenses wear will be defined as 15.00 mm to 19.00 mm inclusive.\n\nExclusion Criteria:\n\n* Disorders that affect sensitivity (herpetic disease, severe diabetes mellitus)\n* Anatomic variations of the conjunctiva that can impair proper scleral lens fitting\n* Pregnancy\n* Best corrected Snellen visual acuity worse than 20/30 in either eye\n* Ocular pathology other than dry eye (e.g. glaucoma, macular degeneration, keratoconus) which may significantly impact visual function.'}, 'identificationModule': {'nctId': 'NCT03417505', 'briefTitle': 'Tangible Hydra-PEG: A Promising Solution for Scleral Lens Wearers With Dry Eye', 'organization': {'class': 'INDUSTRY', 'fullName': 'Tangible Science'}, 'officialTitle': 'Tangible Hydra-PEG: A Promising Solution for Scleral Lens Wearers With Dry Eye', 'orgStudyIdInfo': {'id': 'STM-0686'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treated followed by untreated', 'description': 'Patients wear the Hydra-PEG treated scleral lenses for 30 days. After testing and a post contact lens wear washout period, these patients will then wear the untreated lenses for 30 days. In this arm, the intervention (scleral lenses treated with Tangible Hydra-PEG) is administered prior to the control treatment (untreated scleral lenses).', 'interventionNames': ['Device: Scleral lenses treated with Tangible Hydra-PEG', 'Device: Untreated scleral lenses']}, {'type': 'EXPERIMENTAL', 'label': 'Untreated followed by treated', 'description': 'Patients wear the untreated scleral lenses for 30 days. After testing and a post contact lens wear washout period, these patients will then wear the Hydra-PEG treated lenses for 30 days. In this arm, the intervention (scleral lenses treated with Tangible Hydra-PEG) is administered after the control treatment (untreated scleral lenses).', 'interventionNames': ['Device: Scleral lenses treated with Tangible Hydra-PEG', 'Device: Untreated scleral lenses']}], 'interventions': [{'name': 'Scleral lenses treated with Tangible Hydra-PEG', 'type': 'DEVICE', 'otherNames': ['Tangible Hydra-PEG is a hydrophilic PEG-based lens coating'], 'description': 'Scleral lenses treated with Tangible Hydra-PEG, a hydrophilic, PEG-based contact lens coating designed to improve lens wettability, deposit resistance, and tear film breakup time.', 'armGroupLabels': ['Treated followed by untreated', 'Untreated followed by treated']}, {'name': 'Untreated scleral lenses', 'type': 'DEVICE', 'otherNames': ['control'], 'description': 'Scleral lenses without the Tangible Hydra-PEG treatment will serve as a control.', 'armGroupLabels': ['Treated followed by untreated', 'Untreated followed by treated']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95825', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'University of California, Davis', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '33314', 'city': 'Fort Lauderdale', 'state': 'Florida', 'country': 'United States', 'facility': 'Nova Southeastern University', 'geoPoint': {'lat': 26.12231, 'lon': -80.14338}}, {'zip': '60616', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Illinois College of Optometry', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'Chandra Mickles, OD MS FAAO', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nova Southeastern University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tangible Science', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Nova Southeastern University', 'class': 'OTHER'}, {'name': 'University of California, Davis', 'class': 'OTHER'}, {'name': 'Illinois College of Optometry', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}