Ignite Creation Date:
2025-12-24 @ 3:30 PM
Ignite Modification Date:
2026-02-26 @ 12:41 AM
Study NCT ID:
NCT03674892
Status:
TERMINATED
Last Update Posted:
2025-08-24
First Post:
2018-09-12
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Intranasal Neurostimulation in Ameliorating Symptoms of Neuropathic Corneal Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-03-25', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D003316', 'term': 'Corneal Diseases'}], 'ancestors': [{'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'pedram.hamrah@tuftsmedicine.org', 'phone': '617-636-5720', 'title': 'Pedram Hamrah, MD', 'organization': 'Tufts Medical Center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Patients were not compliant in returning to clinic for follow-up visits. This may be because these visits were to occur on the same day as their routine clinical follow-up visits and the patients repeatedly skipped or cancelled their visits.'}}, 'adverseEventsModule': {'timeFrame': '90 days', 'description': 'Adverse events were collected from patient diaries completed during daily intranasal neurostimulation, verbal reports provided by patients during clinical visits, and patient-completed Ocular Tolerability Questionnaire forms during clinical visits.', 'eventGroups': [{'id': 'EG000', 'title': 'All Patients', 'description': 'All patients participated in this study', 'otherNumAtRisk': 21, 'deathsNumAtRisk': 21, 'otherNumAffected': 13, 'seriousNumAtRisk': 21, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Excessive tearing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Burning Sensation on Eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Foreign Body Sensation on Eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Increased Eye Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Eye Itching', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Forehead throbbing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Migraine Attacks', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Increased Facial Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain in the nose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sinus irritation and Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sinus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sneezing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change to Overall Pain by the Visual Analogue Scale (VAS) After Intranasal Neurostimulator (ITN) Stimulation at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Patients Participated Baseline Visit', 'description': 'Difference of pain scores before and after ITNS at baseline visit\n\nITNS:Intranasal neurostimulation with TrueTear™ intranasal neurostimulator (ITN)'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.81', 'spread': '0.41', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'immediately before and after ITN on Day 1 (baseline)', 'description': "The Visual Analogue Scale (VAS) is a 10 cm line, with one end labeled 'no pain' (which is equivalent to a score of 0 on the numerical scale) and the other end labeled 'worst pain imaginable' (which is equivalent to a score of 10 on the numerical scale). The patient is asked to mark the scale according to the intensity of their eye pain, and the examiner measures the distance in centimeters from the 'no pain' end of the line to score the VAS. The level of discomfort/pain before and after ITN was assessed using the VAS questionnaire (0-10). The changes in overall eye pain after ITN were recorded. Higher scores on the VAS indicate more intense pain and a worse outcome.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Post-stimulation minus pre-stimulation pain scores of all patients who underwent intranasal neurostimulation at the 1-day (baseline) visit.'}, {'type': 'SECONDARY', 'title': 'Change to Overall Pain by the Visual Analogue Scale (VAS) After Daily Intranasal Neurostimulator (ITN) Stimulation Over 45-day Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Patients Participated 45 Day Visit', 'description': 'Difference of pain scores before and after ITNS at 45 Day Visit\n\nITNS:Intranasal neurostimulation with TrueTear™ intranasal neurostimulator (ITN)'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.58', 'spread': '0.39', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'immediately before and after ITN on Day 45', 'description': "The VAS is a 10 cm line, with one end labeled 'no pain' (which is equivalent to a score of 0 on the numerical scale) and the other end labeled 'worst pain imaginable' (which is equivalent to a score of 10 on the numerical scale). The patient is asked to mark the scale according to the intensity of their eye pain, and the examiner measures the distance in centimeters or millimeters from the 'no pain' end of the line to score the VAS. The level of discomfort/pain before and after ITN was assessed using the VAS questionnaire (0-10). The changes in overall eye pain after ITN were recorded. Higher scores on the VAS indicate more intense pain and a worse outcome.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Post-stimulation minus pre-stimulation pain scores of all patients who underwent intranasal neurostimulation at the 45-day visit.'}, {'type': 'SECONDARY', 'title': 'Change to Overall Pain by the Visual Analogue Scale (VAS) After Daily Intranasal Neurostimulator (ITN) Stimulation Over 90-day Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Patients Participated 90 Day Visit', 'description': 'Difference of pain scores before and after ITNS at 90-day visit.\n\nITNS:Intranasal neurostimulation with TrueTear™ intranasal neurostimulator (ITN)'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.75', 'spread': '0.83', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'immediately before and after ITN on Day 90', 'description': "The Visual Analogue Scale (VAS) is a 10 cm line, with one end labeled 'no pain' (which is equivalent to a score of 0 on the numerical scale) and the other end labeled 'worst pain imaginable' (which is equivalent to a score of 10 on the numerical scale). The patient is asked to mark the scale according to the intensity of their eye pain, and the examiner measures the distance in centimeters or millimeters from the 'no pain' end of the line to score the VAS. The level of discomfort/pain before and after ITN was assessed using the VAS questionnaire (0-10). The changes in overall eye pain after ITN were recorded. Higher scores on the VAS indicate more intense pain and a worse outcome.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Post-stimulation minus pre-stimulation pain scores of all patients who underwent intranasal neurostimulation at the 90-day visit.'}, {'type': 'SECONDARY', 'title': 'Quality of Life as Measured With OPAS at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Patients Participated Baseline Visit', 'description': 'Quality of life Scores as measured with Ocular Pain Assessment Survey at 1 day (baseline) Visit'}], 'classes': [{'title': 'Reading and/or computer use', 'categories': [{'measurements': [{'value': '7.37', 'spread': '0.64', 'groupId': 'OG000'}]}]}, {'title': 'Driving and/or watching tv', 'categories': [{'measurements': [{'value': '6.50', 'spread': '0.78', 'groupId': 'OG000'}]}]}, {'title': 'General activity', 'categories': [{'measurements': [{'value': '5.52', 'spread': '0.75', 'groupId': 'OG000'}]}]}, {'title': 'Mood', 'categories': [{'measurements': [{'value': '7.00', 'spread': '0.54', 'groupId': 'OG000'}]}]}, {'title': 'Sleep', 'categories': [{'measurements': [{'value': '4.55', 'spread': '0.77', 'groupId': 'OG000'}]}]}, {'title': 'Enjoying Life/Relationship', 'categories': [{'measurements': [{'value': '6.65', 'spread': '0.73', 'groupId': 'OG000'}]}]}, {'title': 'Time spent thinking about pain', 'categories': [{'measurements': [{'value': '74.12', 'spread': '6.76', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 (Baseline)', 'description': 'The Ocular Pain Assessment Survey (OPAS) is a multidimensional questionnaire that assesses eye pain, non-eye pain, quality of life (QoL), aggravating factors, and associated factors. The QoL section evaluates seven dimensions, with the first six graded using numerical rating scales (0-10) and the final question expressed as a percentage (0-100). Higher scores indicate severe pain and lower QoL in the QoL section of OPAS questionnaire. Ranges: 0-10 for the "Reading and/or computer use", "Driving and/or watching TV", "General Activity", "Mood", "Sleep", "Enjoying Life/ Relationship. "Time spent thinking about pain" dimensions and 0-100. Higher scores indicate worse QoL.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All Patients Participated 1 Day (Baseline) Visit'}, {'type': 'SECONDARY', 'title': 'Quality of Life as Measured Daily With OPAS at 45 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Patients Participated 45 Day Visit', 'description': 'Quality of life Scores as measured with Ocular Pain Assessment Survey at 45 Visit after daily intranasal neurostimulation treatment'}], 'classes': [{'title': 'Reading and/or computer use', 'categories': [{'measurements': [{'value': '5.50', 'spread': '0.85', 'groupId': 'OG000'}]}]}, {'title': 'Driving and/or watching TV', 'categories': [{'measurements': [{'value': '5.03', 'spread': '0.96', 'groupId': 'OG000'}]}]}, {'title': 'General Activity', 'categories': [{'measurements': [{'value': '4.03', 'spread': '0.80', 'groupId': 'OG000'}]}]}, {'title': 'Mood', 'categories': [{'measurements': [{'value': '5.42', 'spread': '0.74', 'groupId': 'OG000'}]}]}, {'title': 'Sleep', 'categories': [{'measurements': [{'value': '3.64', 'spread': '0.90', 'groupId': 'OG000'}]}]}, {'title': 'Enjoying Life/ Relationship', 'categories': [{'measurements': [{'value': '4.89', 'spread': '0.70', 'groupId': 'OG000'}]}]}, {'title': 'Time spent thinking about pain', 'categories': [{'measurements': [{'value': '59.6', 'spread': '8.91', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '45 days', 'description': 'The Ocular Pain Assessment Survey (OPAS) is a multidimensional questionnaire that assesses eye pain, non-eye pain, quality of life (QoL), aggravating factors, and associated factors. The QoL section evaluates seven dimensions, with the first six graded using numerical rating scales (0-10) and the final question expressed as a percentage (0-100). Higher scores indicate severe pain and lower QoL in the QoL section of OPAS questionnaire. Ranges: 0-10 for the "Reading and/or computer use", "Driving and/or watching TV", "General Activity", "Mood", "Sleep", "Enjoying Life/ Relationship. "Time spent thinking about pain" dimensions and 0-100. Higher scores indicate worse QoL.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All Patients Participated 45 Day Visit'}, {'type': 'SECONDARY', 'title': 'Quality of Life as Measured Daily With OPAS at 90 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Patients Participated 90 Day Visit', 'description': 'Quality of life Scores as measured with Ocular Pain Assessment Survey at 90 Visit after daily intranasal neurostimulation treatment'}], 'classes': [{'title': 'Reading and/or computer use', 'categories': [{'measurements': [{'value': '4.80', 'spread': '1.82', 'groupId': 'OG000'}]}]}, {'title': 'Driving and/or watching TV', 'categories': [{'measurements': [{'value': '5.00', 'spread': '1.92', 'groupId': 'OG000'}]}]}, {'title': 'General activity', 'categories': [{'measurements': [{'value': '2.50', 'spread': '0.89', 'groupId': 'OG000'}]}]}, {'title': 'Mood', 'categories': [{'measurements': [{'value': '4.40', 'spread': '1.37', 'groupId': 'OG000'}]}]}, {'title': 'Sleep', 'categories': [{'measurements': [{'value': '2.00', 'spread': '1.37', 'groupId': 'OG000'}]}]}, {'title': 'Enjoying Life/ Relationship', 'categories': [{'measurements': [{'value': '4.30', 'spread': '1.57', 'groupId': 'OG000'}]}]}, {'title': 'Time spent thinking about pain', 'categories': [{'measurements': [{'value': '53.31', 'spread': '26.01', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '90 days', 'description': 'The Ocular Pain Assessment Survey (OPAS) is a multidimensional questionnaire that assesses eye pain, non-eye pain, quality of life (QoL), aggravating factors, and associated factors. The QoL section evaluates seven dimensions, with the first six graded using numerical rating scales (0-10) and the final question expressed as a percentage (0-100). Higher scores indicate severe pain and lower QoL in the QoL section of OPAS questionnaire. Ranges: 0-10 for the "Reading and/or computer use", "Driving and/or watching TV", "General Activity", "Mood", "Sleep", "Enjoying Life/ Relationship. "Time spent thinking about pain" dimensions and 0-100. Higher scores indicate worse QoL.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All Patients Participated 90 Day Visit'}, {'type': 'SECONDARY', 'title': 'Overall Change in Quality of Life as Measured Daily With OPAS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Baseline vs 45-day Visit', 'description': 'Percentage changes in the QoL scores between baseline and 45-day visit after daily ITN\n\nITN: Intranasal neurostimulation with TrueTear™ intranasal neurostimulator QoL: Quality of life dimensions in ocular pain assessment questionnaire'}, {'id': 'OG001', 'title': 'Baseline vs 90-day Visit', 'description': 'Percentage changes in the QoL scores between baseline and 90-day visit after daily ITN\n\nITN: Intranasal neurostimulation with TrueTear™ intranasal neurostimulator QoL: Quality of life dimensions in ocular pain assessment questionnaire'}], 'classes': [{'title': 'Reading and/or computer use', 'categories': [{'measurements': [{'value': '-25.37', 'spread': '11.39', 'groupId': 'OG000'}, {'value': '-34.87', 'spread': '17.72', 'groupId': 'OG001'}]}]}, {'title': 'Driving and/or watching TV', 'categories': [{'measurements': [{'value': '-22.61', 'spread': '11.97', 'groupId': 'OG000'}, {'value': '-23.07', 'spread': '19.32', 'groupId': 'OG001'}]}]}, {'title': 'General Activity', 'categories': [{'measurements': [{'value': '-26.99', 'spread': '30.92', 'groupId': 'OG000'}, {'value': '-54.71', 'spread': '15.02', 'groupId': 'OG001'}]}]}, {'title': 'Mood', 'categories': [{'measurements': [{'value': '-22.57', 'spread': '9.20', 'groupId': 'OG000'}, {'value': '-37.14', 'spread': '10.84', 'groupId': 'OG001'}]}]}, {'title': 'Sleep', 'categories': [{'measurements': [{'value': '-23.95', 'spread': '30.32', 'groupId': 'OG000'}, {'value': '-56.04', 'spread': '40.44', 'groupId': 'OG001'}]}]}, {'title': 'Enjoying life/ Relationship', 'categories': [{'measurements': [{'value': '-26.46', 'spread': '13.94', 'groupId': 'OG000'}, {'value': '-35.33', 'spread': '26.20', 'groupId': 'OG001'}]}]}, {'title': 'Time spent thinking about pain', 'categories': [{'measurements': [{'value': '-19.56', 'spread': '34.50', 'groupId': 'OG000'}, {'value': '-28.07', 'spread': '25.72', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline vs day 45 visit and Baseline vs day 90 visit', 'description': 'The Ocular Pain Assessment Survey (OPAS) is a multidimensional questionnaire that assesses eye pain, non-eye pain, quality of life (QoL), aggravating factors, and associated factors. The QoL section evaluates seven dimensions, with the first six graded using numerical rating scales (0-10) and the final question expressed as a percentage (0-100). Higher scores indicate severe pain and lower QoL in the QoL section of OPAS questionnaire.\n\nPercentage changes in the scores between baseline vs 45-day visit and baseline vs 90-day visit after daily intranasal neurostimulation are given below.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients participated INSTANT study visits'}, {'type': 'SECONDARY', 'title': 'Percent Change From Pain Level Dimension Questions of the Ocular Pain Assessment Survey (OPAS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Baseline vs 45-Day Visit', 'description': 'Percentage Changes in Pain Intensity on the Ocular Pain Assessment Survey Between Baseline and the 45-Day Visit after daily ITN\n\nITN: Intranasal neurostimulation with TrueTear™ intranasal neurostimulator'}, {'id': 'OG001', 'title': 'Baseline vs 90-Day Visit', 'description': 'Percentage Changes in Pain Intensity on the Ocular Pain Assessment Survey Between Baseline and the 90-Day Visit after daily ITN\n\nITN: Intranasal neurostimulation with TrueTear™ intranasal neurostimulator'}], 'classes': [{'title': 'Most eye pain in 24 hours', 'categories': [{'measurements': [{'value': '-31.76', 'spread': '18.76', 'groupId': 'OG000'}, {'value': '-54.25', 'spread': '20.55', 'groupId': 'OG001'}]}]}, {'title': 'Least eye pain in 24 hours', 'categories': [{'measurements': [{'value': '-12.14', 'spread': '22.67', 'groupId': 'OG000'}, {'value': '-37.69', 'spread': '25.46', 'groupId': 'OG001'}]}]}, {'title': 'Average eye pain in 24 hours', 'categories': [{'measurements': [{'value': '-30.43', 'spread': '20.17', 'groupId': 'OG000'}, {'value': '-46.08', 'spread': '21.35', 'groupId': 'OG001'}]}]}, {'title': 'Most eye pain in 2 weeks', 'categories': [{'measurements': [{'value': '-22.89', 'spread': '18.43', 'groupId': 'OG000'}, {'value': '-43.73', 'spread': '16.57', 'groupId': 'OG001'}]}]}, {'title': 'Least eye pain in 2 weeks', 'categories': [{'measurements': [{'value': '-19.75', 'spread': '25.93', 'groupId': 'OG000'}, {'value': '-37.50', 'spread': '26.93', 'groupId': 'OG001'}]}]}, {'title': 'Average eye pain in 2 weeks', 'categories': [{'measurements': [{'value': '-24.77', 'spread': '22.18', 'groupId': 'OG000'}, {'value': '-46.90', 'spread': '20.85', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline vs day 45 visit and Baseline vs day 90 visit', 'description': 'The Ocular Pain Assessment Survey (OPAS) is a multidimensional questionnaire that assesses eye pain, non-eye pain, quality of life (QoL), aggravating factors, and associated factors. Eye pain intensity was assessed using a numerical scale (0-10) for the most, least, and average pain in the past 24 hours and 2 weeks. Higher scores indicate severe pain of OPAS questionnaire. The percent changes in pain intensity between baseline vs 45-day and baseline vs 90-day are provided below.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients participated INSTANT study visits'}, {'type': 'SECONDARY', 'title': 'Overall Percent Change on Impact of Dry Eye in Everyday Life (IDEEL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Baseline vs 45 Day Visit', 'description': 'Overall Percent Change on IDEEL questionnaire between baseline and 45 day visit\n\nIDEEL: Impact of Dry Eye in Everyday Life\n\nTrueTear™ intranasal neurostimulator (ITN)\n\nTrueTear™ intranasal neurostimulator (ITN): TrueTear™ intranasal neurostimulator (ITN)'}, {'id': 'OG001', 'title': 'Baseline vs 90 Day Visit', 'description': 'Overall Percent Change on IDEEL questionnaire between baseline and 90 day visit\n\nIDEEL: Impact of Dry Eye in Everyday Life\n\nTrueTear™ intranasal neurostimulator (ITN)\n\nTrueTear™ intranasal neurostimulator (ITN): TrueTear™ intranasal neurostimulator (ITN)'}], 'classes': [{'title': 'Daily Activities', 'categories': [{'measurements': [{'value': '16.14', 'spread': '23.72', 'groupId': 'OG000'}, {'value': '21.83', 'spread': '17.93', 'groupId': 'OG001'}]}]}, {'title': 'Feelings', 'categories': [{'measurements': [{'value': '17.06', 'spread': '17.38', 'groupId': 'OG000'}, {'value': '40.73', 'spread': '38.43', 'groupId': 'OG001'}]}]}, {'title': 'Work', 'categories': [{'measurements': [{'value': '46.91', 'spread': '17.82', 'groupId': 'OG000'}, {'value': '48.80', 'spread': '40.45', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline vs day 45 visit and Baseline vs day 90 visit', 'description': 'IDEEL Quality of Life Questionnaire is a 27-item questionnaire, designed specifically for DED and is divided into three parts. It assesses the quality of life in three aspects of life for the previous 2 weeks: daily activities, work and feelings. The quality of life is assessed on a scale of 0-5, with zero being inability to do the activity. The score is calculated between 0 - 100 with higher scores indicating a better quality of life. Percentage change in IDEEL questionnaire subheading between baseline and day 45 and baseline and day 90 were given below.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients participated INSTANT visits.'}, {'type': 'SECONDARY', 'title': 'Change in the Intraocular Pressure (IOP) Measured in Each Visit.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Baseline vs 45 Day Visit', 'description': 'Difference of IOP (intraocular pressure) between baseline and 45 days visits after daily TrueTear™ intranasal neurostimulator (ITN) use.'}, {'id': 'OG001', 'title': 'Baseline vs 90 Day Visit', 'description': 'Difference of IOP (intraocular pressure) between baseline and 90 days visits after daily TrueTear™ intranasal neurostimulator use.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.18', 'spread': '1.10', 'groupId': 'OG000'}, {'value': '-0.43', 'spread': '0.92', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline vs day 45 visit and Baseline vs day 90 visit', 'description': 'Intraocular pressure will be measured by an applanation tonometer used on slit lamp (Goldmann) in mmHg. Change in IOP values between baseline and 90-day is provided below. A healthy eye pressure is between 10 and 21 millimeters of mercury. The differences in intraocular pressure between the baseline and day 45 visits, as well as between the baseline and day 90 visits, are presented below.', 'unitOfMeasure': 'millimeters of mercury (mmHg)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients participated INSTANT study visits.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adverse Events (Safety)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Patients', 'description': 'All Patients Who Participated in This Study Were Evaluated for the Safety of ITN\n\nITN: TrueTear™ intranasal neurostimulator'}], 'classes': [{'title': 'Migraine Attacks', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Increased Eye Pain', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Increased Facial Pain', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Sinus Irritation and Pain', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Sinus Infection', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Excessive Tearing', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Pain in the nose', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '90 days', 'description': 'For safety analyses during the study, patient-reported adverse events that developed after intranasal neurostimulation were recorded.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients who underwent intranasal neurostimulation were evaluated for safety measures.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adverse Events (Tolerability)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Patients', 'description': 'All Patients Who Participated in This Study Were Evaluated for the Tolerability of ITN\n\nITN: TrueTear™ intranasal neurostimulator (ITN)'}], 'classes': [{'title': 'Eye Itching', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Burning sensation', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Foreign Body Sensation', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Sneezing', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Forehead Throbbing', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '90 days', 'description': 'Tolerability of Intranasal Neurostimulator (ITN) was evaluated by using Ocular Tolerability and Compliance Questionnaire. It assesses symptoms of discomfort in each eye after ITN use.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients who underwent intranasal neurostimulation and completed Ocular Tolerability and Compliance Questionnaire.'}, {'type': 'SECONDARY', 'title': 'Reduction on Other Concomitant Pain Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Baseline vs 45 Day Visit', 'description': 'Difference in the Number of Systemic Pain Medications Between Baseline and 45-Day Visits After Daily Use of the TrueTear™ Intranasal Neurostimulator'}, {'id': 'OG001', 'title': 'Baseline vs 90 Day Visit', 'description': 'Difference in the Number of Systemic Pain Medications Between Baseline and 90-Day Visits After Daily Use of the TrueTear™ Intranasal Neurostimulator'}], 'classes': [{'categories': [{'measurements': [{'value': '0.14', 'spread': '0.08', 'groupId': 'OG000'}, {'value': '-0.25', 'spread': '0.25', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline vs 45 Day Visit and baseline vs 90 Day Visit', 'description': 'After daily intranasal neurostimulation, the change in the number of systemic pain medication between baseline vs 45-day visit and Baseline vs 90-day visit was evaluated.', 'unitOfMeasure': 'Number of medication (n)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'INSTANT patients participated baseline-45 Day Visit and baseline-90 Day Visit'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Experimental: TrueTear™ Intranasal Neurostimulator (ITN)', 'description': 'The TrueTear® ITN, recently approved by the FDA, is a portable neuromodulation device that delivers a small electrical current to the sensory nerves in the nasal cavity that stimulates the nasolacrimal reflex (NLR).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}]}, {'type': 'Month 1 Visit 3', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}]}], 'dropWithdraws': [{'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'Migraine', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Excessive Tearing', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Increased Eye Pain', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Increased Facial Pain', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Sinus Irritation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Sinus Infection', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': 'As outlined in the study protocol, this trial aimed to enroll 45 patients with neuropathic corneal pain and evaluate them at 45 and 90 days following daily use of the TrueTear™ device. However, due to the COVID-19 pandemic and related concerns about infection, only 21 patients enrolled in the study and completed the first visit. As this was a single arm study, all participants were assigned to the TrueTear™ intranasal neurostimulator (ITN) group.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'TrueTear™ Intranasal Neurostimulator (ITN)', 'description': 'TrueTear™ intranasal neurostimulator (ITN)\n\nTrueTear™ intranasal neurostimulator (ITN): TrueTear™ intranasal neurostimulator (ITN)'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '53.05', 'spread': '14.82', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '18', '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.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Randomly Selected Eye for Analysis (Right eye/Left eye)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Right eye OD', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}, {'title': 'Left eye OS', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Best Corrected Visual Acuity', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '0.09', 'spread': '0.10', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'logMAR', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Schirmer', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '8.71', 'spread': '7.00', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'The Schirmer test was performed by placing a narrow filter-paper strip (5 x 35 mm strip of Whatman #41 filter paper) in the inferior cul-de-sac. The subject should gently close their eyes until five minutes have elapsed and the strips are removed. Aqueous tear production was measured by the length in millimeters that the strip wets during 5 minutes. The Schirmer test results range from 0 to 35 mm, with lower values indicating more severe dry eye.', 'unitOfMeasure': 'millimeters', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Tear Break Up Time', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '6.70', 'spread': '2.69', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'seconds', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Corneal Staining Score', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '2.56', 'spread': '4.03', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Corneal Staining Score: The NEI (National Eye Institute) corneal staining score is a standardized method used to assess the extent of corneal epithelial damage, typically visualized with fluorescein dye under cobalt blue light. The cornea is divided into five equal zones. Each zone is graded on a scale from 0 to 3, based on the number and density of punctate epithelial erosions (staining spots). The scores from all five zones are summed (0-15), giving a total corneal staining score. Higher scores indicates more severe dryness.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Conjunctival Staining Score', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '2.44', 'spread': '4.03', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'The NEI (National Eye Institute) conjunctival staining score is used to assess damage or dryness-related staining of the bulbar conjunctiva by using lissamine green. The exposed bulbar conjunctiva is divided into six regions. Each zone is scored from 0 to 3, The scores for all six zones are summed, giving a total conjunctival staining score. The conjunctival staining score ranges from 0 to 18, with higher scores indicating more severe dry eye.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Intraocular Pressure', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '13.76', 'spread': '3.22', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'millimeters of mercury (mmHg)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Proparacaine Challenge Test', 'classes': [{'title': 'Before', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '5.80', 'spread': '3.08', 'groupId': 'BG000'}]}]}, {'title': 'After', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '1.80', 'spread': '1.54', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': "Patients marked their current pain intensity on a 10 cm horizontal visual analogue scale (VAS), with 'no pain' (0) at the left end and 'worst imaginable pain' (10) at the right end. This score was recorded as centimeter and given as 'before'. One drop of Proparacaine was then topically applied, and after 90 seconds, patients marked their pain intensity on the same scale. This second score was recorded and given as 'after'. The pain scale ranges from 0 to 10, with higher scores indicating greater pain severity.", 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Proparacaine Challenge Test Percent Change', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '-68.96', 'spread': '19.12', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'The mean post-instillation pain intensity was subtracted from the mean pre-instillation value, divided by the mean pre-instillation intensity, and multiplied by 100 to calculate the percentage of pain change following proparacaine eyedrop instillation. Values range from -100 to 0; a value of -100 indicates that corneal pain originated entirely from peripheral corneal nerves, whereas 0 indicates that the pain originated entirely from non-ocular surface sources, such as the trigeminal ganglion or the upstream central nervous system.', 'unitOfMeasure': 'percentage change', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Cold Saline Test', 'classes': [{'title': 'Before', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '4.40', 'spread': '2.21', 'groupId': 'BG000'}]}]}, {'title': 'After', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '2.75', 'spread': '2.24', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': "Patients marked their current pain intensity on a 10 cm horizontal visual analogue scale (VAS), with 'no pain' (0) at the left end and 'worst imaginable pain' (10) at the right end. This score was recorded in centimeter and given as 'before'. One drop of cold 0.9% preservative-free saline was then topically applied, and immediately after patients marked their pain intensity on the same scale. This second score was recorded and given as 'after'. Higher scores indicate greater pain severity.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Hypertonic Test', 'classes': [{'title': 'Before', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '3.30', 'spread': '2.79', 'groupId': 'BG000'}]}]}, {'title': 'After', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '5.25', 'spread': '3.53', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': "Patients marked their current pain intensity on a 10 cm horizontal visual analogue scale (VAS), with 'no pain' (0) at the left end and 'worst imaginable pain' (10) at the right end. This score was recorded in centimeters and designated as 'before'. One drop of 5% sodium chloride (Muro 128®) was then topically applied, and after twenty seconds, patients marked their pain intensity on the same scale. This second score was recorded and designated as 'after'. The pain scale ranges from 0 to 10, with higher scores indicating greater pain severity.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Neuropathic Corneal Pain Type', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Peripheral', 'measurements': [{'value': '16', 'groupId': 'BG000'}]}, {'title': 'Mixed', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': "One drop of Proparacaine Hydrochloride Ophthalmic Solution 0.5% was topically applied in both eyes to differentiate between the peripheral versus central component of the patient's eye pain or discomfort. The level of discomfort/pain was then assessed by the visual analogue scale (VAS) questionnaire. Patients who experienced complete eye pain relief after proparacaine instillation were classified as having peripheral neuropathic corneal pain, whereas those with partial relief were classified as having mixed neuropathic corneal pain.", 'unitOfMeasure': 'Participants'}, {'title': 'Pain Intensity', 'classes': [{'title': 'Pre-stimulation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '5.73', 'spread': '2.09', 'groupId': 'BG000'}]}]}, {'title': 'Post-stimulation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '1.92', 'spread': '1.67', 'groupId': 'BG000'}]}]}, {'title': 'Difference', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '-3.81', 'spread': '1.88', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': "Patients marked their current pain intensity on a 10 cm horizontal visual analogue scale, with 'no pain' (0) at the left end and 'worst imaginable pain' (10) at the right end. This score was recorded as 'Pre-stimulation'. Each participant was asked to apply the intranasal neurostimulation device for 1 minute, and if no change in discomfort is noted, to continue for up to 3 minutes. Then patients marked their pain intensity on the same scale and recorded as 'Post-stimulation'. The pain scale ranges from 0 to 10, with higher scores indicating greater pain severity.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Pain Intensity Change Percent after Intranasal Neurostimulation', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '-66.49', 'spread': '29.38', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Pain Intensity Change Percent after Intranasal Neurostimulation was calculated by subtracting the mean post-stimulation pain intensity from the mean pre-stimulation value, then dividing by the mean pre-stimulation intensity and multiplying by 100 to obtain the percentage change. Values ranged from -100 to 100, with higher values indicating less pain reduction or pain increase after intranasal neurostimulation and a worse outcome.', 'unitOfMeasure': 'percent change', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Ocular Surface Disease Index (OSDI) Score', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '69.96', 'spread': '19.83', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': "The Ocular Surface Disease Index (OSDI) is a 12-item questionnaire, with each question scored on a scale from 0 to 4, where 0 indicates 'none of the time' and 4 indicates 'all of the time.' To calculate the OSDI score, the sum of the scores from all answered questions was multiplied by 25 and then divided by the total number of questions answered. OSDI scores range from 0 to 100, with higher scores indicating more severe ocular surface symptoms and a worse outcome.", 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Ocular Surface Disease Index (OSDI) Dimensions', 'classes': [{'title': 'Light Sensitivity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '2.85', 'spread': '1.56', 'groupId': 'BG000'}]}]}, {'title': 'Gritty', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '2.37', 'spread': '1.30', 'groupId': 'BG000'}]}]}, {'title': 'Painful Eyes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '3.30', 'spread': '0.86', 'groupId': 'BG000'}]}]}, {'title': 'Blurred Eyes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '2.30', 'spread': '1.49', 'groupId': 'BG000'}]}]}, {'title': 'Poor Vision', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '2.26', 'spread': '1.36', 'groupId': 'BG000'}]}]}, {'title': 'Reading', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '2.61', 'spread': '0.97', 'groupId': 'BG000'}]}]}, {'title': 'Driving Night', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '2.50', 'spread': '1.54', 'groupId': 'BG000'}]}]}, {'title': 'Working ATM/Computer', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '3.11', 'spread': '1.13', 'groupId': 'BG000'}]}]}, {'title': 'Watching TV', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '2.94', 'spread': '2.01', 'groupId': 'BG000'}]}]}, {'title': 'Windy Conditions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '3.17', 'spread': '1.15', 'groupId': 'BG000'}]}]}, {'title': 'Low Humidity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '3.53', 'spread': '0.62', 'groupId': 'BG000'}]}]}, {'title': 'Areas with Air Conditioner', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '3.64', 'spread': '0.63', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': '(0 = None of the time, 1 = Some of the time, 2 = Half of the time, 3 = Most of the time, 4 = All of the time)', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Ocular Pain Assessment Survey (OPAS) Dimensions', 'classes': [{'title': 'Overall Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '5.50', 'spread': '2.42', 'groupId': 'BG000'}]}]}, {'title': 'Most Eye Pain Intensity in the past 24 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '7.87', 'spread': '1.99', 'groupId': 'BG000'}]}]}, {'title': 'Least Eye Pain Intensity in the past 24 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '3.21', 'spread': '2.10', 'groupId': 'BG000'}]}]}, {'title': 'Average Eye Pain Intensity in the past 24 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '5.75', 'spread': '1.96', 'groupId': 'BG000'}]}]}, {'title': 'Most Eye Pain Intensity in the past 2 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '7.82', 'spread': '2.02', 'groupId': 'BG000'}]}]}, {'title': 'Least Eye Pain Intensity in the past 2 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '4.00', 'spread': '2.29', 'groupId': 'BG000'}]}]}, {'title': 'Average Eye Pain Intensity in the past 2 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '5.65', 'spread': '1.96', 'groupId': 'BG000'}]}]}, {'title': 'Non-Eye Pain in the past 24 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '4.68', 'spread': '3.64', 'groupId': 'BG000'}]}]}, {'title': 'Non-Eye Pain in the past 2 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '5.42', 'spread': '3.92', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'The overall severity of pain (0 = no pain, 10 = worst pain ever)', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Ocular Pain Assessment Survey (OPAS)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '46.68', 'spread': '36.90', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'The percentage of time spent thinking about non-eye pain (face/head) (0% = Not at all, 100% = All the time)', 'unitOfMeasure': 'The percentage of time (%)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Ocular Pain Assessment Survey (OPAS) Quality of Life Parameters', 'classes': [{'title': 'Reading', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '7.37', 'spread': '2.88', 'groupId': 'BG000'}]}]}, {'title': 'Driving', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '6.50', 'spread': '3.31', 'groupId': 'BG000'}]}]}, {'title': 'General activity (walking, doing house chores)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '5.52', 'spread': '3.31', 'groupId': 'BG000'}]}]}, {'title': 'Mood', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '7.00', 'spread': '2.45', 'groupId': 'BG000'}]}]}, {'title': 'Sleep', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '4.55', 'spread': '3.28', 'groupId': 'BG000'}]}]}, {'title': 'Enjoying Life/ Relations with other people', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '6.65', 'spread': '3.26', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'How much pain has interfered with/affected the following (0 = Not at all, 10 = Completely)', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Ocular Pain Assessment Survey (OPAS) Quality of Life Parameters', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '74.12', 'spread': '27.90', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': "The final dimension of the Ocular Pain Assessment Survey's Quality of Life section assesses the percentage of time the patient spends thinking about eye pain. Scores range from 0 to 100, with higher scores indicating more time spent thinking about eye pain and greater pain severity.", 'unitOfMeasure': 'The percentage of time (%)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Ocular Pain Assessment Survey (OPAS) Average Quality of Life (QoL) Score:', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '6.46', 'spread': '2.48', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'The Quality of Life (QoL) section of Ocular Pain Assessment Survey (OPAS) includes 7 items: the first 6 are rated on a 0-10 scale, while the last item is scored as a percentage (0-100). To calculate the average OPAS QoL score, the percentage-based item is first converted to a 0-10 scale. Then, the sum of all answered item scores is divided by the total number of items completed. OPAS Average QoL scores range from 0 to 10, with higher scores indicating greater interference of daily activities due to ocular surface symptoms, lower QoL, and a worse outcome.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Ocular Pain Assessment Survey (OPAS) Aggravating Factors', 'classes': [{'title': 'Wind, dry air, heat, air conditioning', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '79.72', 'spread': '32.47', 'groupId': 'BG000'}]}]}, {'title': 'Volatile chemicals (cleaning agents, fumes, cosmetic)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '65.00', 'spread': '38.17', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'How much pain is increased when exposed to the following factors (0% = No change, 100% = Severe increase)', 'unitOfMeasure': 'percent (%)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Ocular Pain Assessment Survey (OPAS) Associated Factors', 'classes': [{'title': 'Redness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '50.26', 'spread': '34.74', 'groupId': 'BG000'}]}]}, {'title': 'Burning', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '73.00', 'spread': '25.15', 'groupId': 'BG000'}]}]}, {'title': 'Sensitivity to light', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '75.25', 'spread': '36.65', 'groupId': 'BG000'}]}]}, {'title': 'Tearing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '38.95', 'spread': '36.99', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'How often eye pain is accompanied by the following symptoms (0% = Never, 100% = All the time)', 'unitOfMeasure': 'percent (%)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Ocular Pain Assessment Survey (OPAS) Symptom Relief', 'classes': [{'title': 'Eye Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '33.63', 'spread': '23.03', 'groupId': 'BG000'}]}]}, {'title': 'Non-Eye Pain (face/head)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '23.75', 'spread': '27.61', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Pain relief experienced since last visit (0% = No relief, 100% = Complete relief)', 'unitOfMeasure': 'percent (%)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Impact of Dry Eye in Everyday Life (IDEEL) Daily Activities', 'classes': [{'title': 'Doing close work in the morning or afternoon', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '2.60', 'spread': '1.59', 'groupId': 'BG000'}]}]}, {'title': 'Doing close work in the evening or at night', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '2.73', 'spread': '1.43', 'groupId': 'BG000'}]}]}, {'title': 'Driving', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '3.35', 'spread': '1.64', 'groupId': 'BG000'}]}]}, {'title': 'Being around and/or using scented products', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '3.21', 'spread': '1.96', 'groupId': 'BG000'}]}]}, {'title': 'Working on a computer', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '2.46', 'spread': '1.68', 'groupId': 'BG000'}]}]}, {'title': 'Going somewhere where there is tobacco smoke', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '2.40', 'spread': '1.91', 'groupId': 'BG000'}]}]}, {'title': 'Wearing contact lenses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '3.92', 'spread': '2.05', 'groupId': 'BG000'}]}]}, {'title': 'Wearing make-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '2.57', 'spread': '1.86', 'groupId': 'BG000'}]}]}, {'title': 'Flying on an airplane', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '3.53', 'spread': '1.71', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'The IDEEL questionnaire is a 57-item instrument and comprises three modules: dry eye impact on daily life, dry eye treatment satisfaction, and dry eye symptom bothers. In this study, the dry eye impact on daily life module was used, which consists of 27 items and assesses Quality of Life (QoL) in three aspects over the previous two weeks: daily activities, feelings, and work. Aside from the yes-or-no questions, the other questions are answered on a 0-5 Likert scale, where zero signifies an inability to perform the activity. Lower scores indicate more severe disability and worse outcome.', 'unitOfMeasure': 'Scores on a Scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Impact of Dry Eye in Everyday Life (IDEEL) Feelings', 'classes': [{'title': 'Irritability', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '1.73', 'spread': '1.03', 'groupId': 'BG000'}]}]}, {'title': 'Impatience', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '2.13', 'spread': '1.12', 'groupId': 'BG000'}]}]}, {'title': 'Feeling sad', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '1.80', 'spread': '1.20', 'groupId': 'BG000'}]}]}, {'title': 'Worry that my dry eyes will get worse', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '1.33', 'spread': '1.32', 'groupId': 'BG000'}]}]}, {'title': 'Feeling annoyed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '1.93', 'spread': '1.22', 'groupId': 'BG000'}]}]}, {'title': 'Feeling like my eyes do not look nice', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '1.66', 'spread': '1.44', 'groupId': 'BG000'}]}]}, {'title': 'Feeling like I have to make adjustments to my life', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '1.06', 'spread': '1.12', 'groupId': 'BG000'}]}]}, {'title': 'Feeling different from other people', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '1.66', 'spread': '1.63', 'groupId': 'BG000'}]}]}, {'title': 'Feeling like I am always aware of my eyes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '0.80', 'spread': '1.08', 'groupId': 'BG000'}]}]}, {'title': 'Feeling older than I really am', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '2.00', 'spread': '1.64', 'groupId': 'BG000'}]}]}, {'title': "Feeling like people look at me and think I am fine when I'm not", 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '1.73', 'spread': '1.66', 'groupId': 'BG000'}]}]}, {'title': 'Feeling like there is nothing I can do for my dry eyes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '1.26', 'spread': '1.38', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'How often feelings are had because of dry eyes over the last two weeks (1 = All of the time, 2 = Most of the time, 3 = Some of the time, 4 = A little of the time, 5 = None of the time)', 'unitOfMeasure': 'Scores on a Scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Impact of Dry Eye in Everyday Life (IDEEL) Work', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}, {'title': 'No', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'No answer', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Impact of Dry Eye in Everyday Life (IDEEL) Situations at Work', 'classes': [{'title': 'Feeling distracted', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '1.64', 'spread': '1.00', 'groupId': 'BG000'}]}]}, {'title': "Feeling like I couldn't concentrate", 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '1.71', 'spread': '1.06', 'groupId': 'BG000'}]}]}, {'title': 'Having to take a break from work', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '1.38', 'spread': '1.12', 'groupId': 'BG000'}]}]}, {'title': 'Having to change the way I work', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '1.28', 'spread': '1.26', 'groupId': 'BG000'}]}]}, {'title': 'Having to change my work environment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '1.28', 'spread': '1.58', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'How often were the following situations experienced over the last two weeks at work because of dry eyes? (0 = All of the time, 1 = Most of the time, 2 = Some of the time, 3 = A little of the time, 4 = None of the time)', 'unitOfMeasure': 'IDEEL Score', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Filter Glasses Test', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '78.00', 'spread': '8.36', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'This test was done in a dimly lit room and each eye was assessed separately. The other eye was covered with an occluder to eliminate exposure to the light. The study eye was covered using a 100% opaque filter, and then the opacity of the filters was reduced in decrements of 10%. Ten graded filters were developed for this purpose; starting with the 100% opaque filter, the filter at which the patient started to feel pain/photophobia was noted. Values range 0-100; higher opacity filters reflect more photosensitivity and a worse outcome.', 'unitOfMeasure': 'Units on a scale (0-100)', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-07-20', 'size': 2258195, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_002.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-04-29T11:41', 'hasProtocol': True}, {'date': '2020-08-12', 'size': 655831, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2025-02-24T16:31', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'non-randomized, open-label, single arm pilot trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}}, 'statusModule': {'whyStopped': 'Original device is now discontinued; we are changing the study device shortly', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2018-09-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2023-09-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-06', 'studyFirstSubmitDate': '2018-09-12', 'resultsFirstSubmitDate': '2025-02-24', 'studyFirstSubmitQcDate': '2018-09-14', 'lastUpdatePostDateStruct': {'date': '2025-08-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-08-06', 'studyFirstPostDateStruct': {'date': '2018-09-18', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-08-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change to Overall Pain by the Visual Analogue Scale (VAS) After Intranasal Neurostimulator (ITN) Stimulation at Baseline', 'timeFrame': 'immediately before and after ITN on Day 1 (baseline)', 'description': "The Visual Analogue Scale (VAS) is a 10 cm line, with one end labeled 'no pain' (which is equivalent to a score of 0 on the numerical scale) and the other end labeled 'worst pain imaginable' (which is equivalent to a score of 10 on the numerical scale). The patient is asked to mark the scale according to the intensity of their eye pain, and the examiner measures the distance in centimeters from the 'no pain' end of the line to score the VAS. The level of discomfort/pain before and after ITN was assessed using the VAS questionnaire (0-10). The changes in overall eye pain after ITN were recorded. Higher scores on the VAS indicate more intense pain and a worse outcome."}], 'secondaryOutcomes': [{'measure': 'Change to Overall Pain by the Visual Analogue Scale (VAS) After Daily Intranasal Neurostimulator (ITN) Stimulation Over 45-day Period', 'timeFrame': 'immediately before and after ITN on Day 45', 'description': "The VAS is a 10 cm line, with one end labeled 'no pain' (which is equivalent to a score of 0 on the numerical scale) and the other end labeled 'worst pain imaginable' (which is equivalent to a score of 10 on the numerical scale). The patient is asked to mark the scale according to the intensity of their eye pain, and the examiner measures the distance in centimeters or millimeters from the 'no pain' end of the line to score the VAS. The level of discomfort/pain before and after ITN was assessed using the VAS questionnaire (0-10). The changes in overall eye pain after ITN were recorded. Higher scores on the VAS indicate more intense pain and a worse outcome."}, {'measure': 'Change to Overall Pain by the Visual Analogue Scale (VAS) After Daily Intranasal Neurostimulator (ITN) Stimulation Over 90-day Period', 'timeFrame': 'immediately before and after ITN on Day 90', 'description': "The Visual Analogue Scale (VAS) is a 10 cm line, with one end labeled 'no pain' (which is equivalent to a score of 0 on the numerical scale) and the other end labeled 'worst pain imaginable' (which is equivalent to a score of 10 on the numerical scale). The patient is asked to mark the scale according to the intensity of their eye pain, and the examiner measures the distance in centimeters or millimeters from the 'no pain' end of the line to score the VAS. The level of discomfort/pain before and after ITN was assessed using the VAS questionnaire (0-10). The changes in overall eye pain after ITN were recorded. Higher scores on the VAS indicate more intense pain and a worse outcome."}, {'measure': 'Quality of Life as Measured With OPAS at Baseline', 'timeFrame': 'Day 1 (Baseline)', 'description': 'The Ocular Pain Assessment Survey (OPAS) is a multidimensional questionnaire that assesses eye pain, non-eye pain, quality of life (QoL), aggravating factors, and associated factors. The QoL section evaluates seven dimensions, with the first six graded using numerical rating scales (0-10) and the final question expressed as a percentage (0-100). Higher scores indicate severe pain and lower QoL in the QoL section of OPAS questionnaire. Ranges: 0-10 for the "Reading and/or computer use", "Driving and/or watching TV", "General Activity", "Mood", "Sleep", "Enjoying Life/ Relationship. "Time spent thinking about pain" dimensions and 0-100. Higher scores indicate worse QoL.'}, {'measure': 'Quality of Life as Measured Daily With OPAS at 45 Days', 'timeFrame': '45 days', 'description': 'The Ocular Pain Assessment Survey (OPAS) is a multidimensional questionnaire that assesses eye pain, non-eye pain, quality of life (QoL), aggravating factors, and associated factors. The QoL section evaluates seven dimensions, with the first six graded using numerical rating scales (0-10) and the final question expressed as a percentage (0-100). Higher scores indicate severe pain and lower QoL in the QoL section of OPAS questionnaire. Ranges: 0-10 for the "Reading and/or computer use", "Driving and/or watching TV", "General Activity", "Mood", "Sleep", "Enjoying Life/ Relationship. "Time spent thinking about pain" dimensions and 0-100. Higher scores indicate worse QoL.'}, {'measure': 'Quality of Life as Measured Daily With OPAS at 90 Days', 'timeFrame': '90 days', 'description': 'The Ocular Pain Assessment Survey (OPAS) is a multidimensional questionnaire that assesses eye pain, non-eye pain, quality of life (QoL), aggravating factors, and associated factors. The QoL section evaluates seven dimensions, with the first six graded using numerical rating scales (0-10) and the final question expressed as a percentage (0-100). Higher scores indicate severe pain and lower QoL in the QoL section of OPAS questionnaire. Ranges: 0-10 for the "Reading and/or computer use", "Driving and/or watching TV", "General Activity", "Mood", "Sleep", "Enjoying Life/ Relationship. "Time spent thinking about pain" dimensions and 0-100. Higher scores indicate worse QoL.'}, {'measure': 'Overall Change in Quality of Life as Measured Daily With OPAS', 'timeFrame': 'Baseline vs day 45 visit and Baseline vs day 90 visit', 'description': 'The Ocular Pain Assessment Survey (OPAS) is a multidimensional questionnaire that assesses eye pain, non-eye pain, quality of life (QoL), aggravating factors, and associated factors. The QoL section evaluates seven dimensions, with the first six graded using numerical rating scales (0-10) and the final question expressed as a percentage (0-100). Higher scores indicate severe pain and lower QoL in the QoL section of OPAS questionnaire.\n\nPercentage changes in the scores between baseline vs 45-day visit and baseline vs 90-day visit after daily intranasal neurostimulation are given below.'}, {'measure': 'Percent Change From Pain Level Dimension Questions of the Ocular Pain Assessment Survey (OPAS)', 'timeFrame': 'Baseline vs day 45 visit and Baseline vs day 90 visit', 'description': 'The Ocular Pain Assessment Survey (OPAS) is a multidimensional questionnaire that assesses eye pain, non-eye pain, quality of life (QoL), aggravating factors, and associated factors. Eye pain intensity was assessed using a numerical scale (0-10) for the most, least, and average pain in the past 24 hours and 2 weeks. Higher scores indicate severe pain of OPAS questionnaire. The percent changes in pain intensity between baseline vs 45-day and baseline vs 90-day are provided below.'}, {'measure': 'Overall Percent Change on Impact of Dry Eye in Everyday Life (IDEEL)', 'timeFrame': 'Baseline vs day 45 visit and Baseline vs day 90 visit', 'description': 'IDEEL Quality of Life Questionnaire is a 27-item questionnaire, designed specifically for DED and is divided into three parts. It assesses the quality of life in three aspects of life for the previous 2 weeks: daily activities, work and feelings. The quality of life is assessed on a scale of 0-5, with zero being inability to do the activity. The score is calculated between 0 - 100 with higher scores indicating a better quality of life. Percentage change in IDEEL questionnaire subheading between baseline and day 45 and baseline and day 90 were given below.'}, {'measure': 'Change in the Intraocular Pressure (IOP) Measured in Each Visit.', 'timeFrame': 'Baseline vs day 45 visit and Baseline vs day 90 visit', 'description': 'Intraocular pressure will be measured by an applanation tonometer used on slit lamp (Goldmann) in mmHg. Change in IOP values between baseline and 90-day is provided below. A healthy eye pressure is between 10 and 21 millimeters of mercury. The differences in intraocular pressure between the baseline and day 45 visits, as well as between the baseline and day 90 visits, are presented below.'}, {'measure': 'Number of Participants With Adverse Events (Safety)', 'timeFrame': '90 days', 'description': 'For safety analyses during the study, patient-reported adverse events that developed after intranasal neurostimulation were recorded.'}, {'measure': 'Number of Participants With Adverse Events (Tolerability)', 'timeFrame': '90 days', 'description': 'Tolerability of Intranasal Neurostimulator (ITN) was evaluated by using Ocular Tolerability and Compliance Questionnaire. It assesses symptoms of discomfort in each eye after ITN use.'}, {'measure': 'Reduction on Other Concomitant Pain Therapy', 'timeFrame': 'Baseline vs 45 Day Visit and baseline vs 90 Day Visit', 'description': 'After daily intranasal neurostimulation, the change in the number of systemic pain medication between baseline vs 45-day visit and Baseline vs 90-day visit was evaluated.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Intranasal Neurostimulation'], 'conditions': ['Cornea']}, 'descriptionModule': {'briefSummary': 'This study is a prospective, interventional, open-label, single arm, non-randomized trial treating 30 patients with peripheral or mixed neuropathic corneal pain at their baseline exam and following 45 days and 90 days of daily use with the TrueTear™ ITN device.', 'detailedDescription': 'The investigators hypothesize that the stimulation through the ethmoidal nerve in the nasal cavity may have an inhibitory effect on the primary TG interneurons and block the ocular pain signaling to the brain.\n\nThe investigators propose a non-randomized, open-label, single arm pilot trial for treatment of neuropathic corneal pain (NCP) with ITN with the following specific aims:\n\nSpecific Aims:\n\n1. To elucidate the efficacy of ITN in ameliorating pain among neuropathic corneal pain patients.\n2. To elucidate the safety, efficacy, longevity of ITN in ameliorating pain among neuropathic corneal pain patients during a 90-day period with daily use.\n3. To assess quality of life changes by treating neuropathic corneal pain with ITN during a 90-day period with daily use.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '22 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age \\>22\n2. Ability to consent to study.\n3. Symptoms of neuropathic corneal pain for at least 3 months, such as burning, stinging, light sensitivity, discomfort or pain.\n4. Positive in vivo confocal microscopy (IVCM) findings for NCP such as presence of microneuromas and decreased nerve density.\n5. Fifty percent or more relief of pain or discomfort after instillation of Proparacaine eye drops as measured by the Visual Analogue Scale (VAS).\n\nExclusion Criteria:\n\n1. Clinically significant acute ocular surface diseases, such as active infectious keratitis or recent ocular surgery in the past 3 months.\n2. Chronic or recurrent epistaxis, coagulation disorders.\n3. Nasal or sinus surgery or significant trauma to the nose.\n4. Severe nasal airway obstruction or vascularized nasal polyps.\n5. Cardiac demand pacemaker, implanted defibrillator, or other implanted electronic device in the head or neck.\n6. Chronic or recurrent nosebleeds\n7. Bleeding disorder\n8. Known hypersensitivity (allergy) to the hydrogel material\n9. Disabling arthritis, neuropathy, or limited motor coordination affecting self-handling of the device.'}, 'identificationModule': {'nctId': 'NCT03674892', 'acronym': 'INSTANT', 'briefTitle': 'Intranasal Neurostimulation in Ameliorating Symptoms of Neuropathic Corneal Pain', 'organization': {'class': 'OTHER', 'fullName': 'Tufts Medical Center'}, 'officialTitle': 'Assessing the Efficacy of Intranasal Neurostimulation in Ameliorating Symptoms of Neuropathic Corneal Pain', 'orgStudyIdInfo': {'id': '12978'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TrueTear™ intranasal neurostimulator (ITN)', 'description': 'TrueTear™ intranasal neurostimulator (ITN)', 'interventionNames': ['Device: TrueTear™ intranasal neurostimulator (ITN)']}], 'interventions': [{'name': 'TrueTear™ intranasal neurostimulator (ITN)', 'type': 'DEVICE', 'description': 'TrueTear™ intranasal neurostimulator (ITN)', 'armGroupLabels': ['TrueTear™ intranasal neurostimulator (ITN)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02111', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Tufts Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Pedram Hamrah, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tufts Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tufts Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}