22 and older, any sex, with Cornea. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change to Overall Pain by the Visual Analogue Scale (VAS) After Intranasal Neurostimulator (ITN) Stimulation at BaselinePrimary· immediately before and after ITN on Day 1 (baseline)
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
Group
Value
95% CI
All Patients Participated Baseline Visit
-3.81
± 0.41
Change to Overall Pain by the Visual Analogue Scale (VAS) After Daily Intranasal Neurostimulator (ITN) Stimulation Over 45-day PeriodSecondary· immediately before and after ITN on Day 45
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
Group
Value
95% CI
All Patients Participated 45 Day Visit
-1.58
± 0.39
Change to Overall Pain by the Visual Analogue Scale (VAS) After Daily Intranasal Neurostimulator (ITN) Stimulation Over 90-day PeriodSecondary· immediately before and after ITN on Day 90
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 IT
Group
Value
95% CI
All Patients Participated 90 Day Visit
-0.75
± 0.83
Quality of Life as Measured With OPAS at BaselineSecondary· Day 1 (Baseline)
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
Reading and/or computer use
Group
Value
95% CI
All Patients Participated Baseline Visit
7.37
± 0.64
Driving and/or watching tv
Group
Value
95% CI
All Patients Participated Baseline Visit
6.50
± 0.78
General activity
Group
Value
95% CI
All Patients Participated Baseline Visit
5.52
± 0.75
Mood
Group
Value
95% CI
All Patients Participated Baseline Visit
7.00
± 0.54
Sleep
Group
Value
95% CI
All Patients Participated Baseline Visit
4.55
± 0.77
Enjoying Life/Relationship
Group
Value
95% CI
All Patients Participated Baseline Visit
6.65
± 0.73
Time spent thinking about pain
Group
Value
95% CI
All Patients Participated Baseline Visit
74.12
± 6.76
Quality of Life as Measured Daily With OPAS at 45 DaysSecondary· 45 days
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
Reading and/or computer use
Group
Value
95% CI
All Patients Participated 45 Day Visit
5.50
± 0.85
Driving and/or watching TV
Group
Value
95% CI
All Patients Participated 45 Day Visit
5.03
± 0.96
General Activity
Group
Value
95% CI
All Patients Participated 45 Day Visit
4.03
± 0.80
Mood
Group
Value
95% CI
All Patients Participated 45 Day Visit
5.42
± 0.74
Sleep
Group
Value
95% CI
All Patients Participated 45 Day Visit
3.64
± 0.90
Enjoying Life/ Relationship
Group
Value
95% CI
All Patients Participated 45 Day Visit
4.89
± 0.70
Time spent thinking about pain
Group
Value
95% CI
All Patients Participated 45 Day Visit
59.6
± 8.91
Quality of Life as Measured Daily With OPAS at 90 DaysSecondary· 90 days
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
Reading and/or computer use
Group
Value
95% CI
All Patients Participated 90 Day Visit
4.80
± 1.82
Driving and/or watching TV
Group
Value
95% CI
All Patients Participated 90 Day Visit
5.00
± 1.92
General activity
Group
Value
95% CI
All Patients Participated 90 Day Visit
2.50
± 0.89
Mood
Group
Value
95% CI
All Patients Participated 90 Day Visit
4.40
± 1.37
Sleep
Group
Value
95% CI
All Patients Participated 90 Day Visit
2.00
± 1.37
Enjoying Life/ Relationship
Group
Value
95% CI
All Patients Participated 90 Day Visit
4.30
± 1.57
Time spent thinking about pain
Group
Value
95% CI
All Patients Participated 90 Day Visit
53.31
± 26.01
Overall Change in Quality of Life as Measured Daily With OPASSecondary· Baseline vs day 45 visit and Baseline vs day 90 visit
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.
Percentage changes in the scores between baseline vs 45-day visit and baseline vs 90-day visit after daily intranasal neurostimulation are given below.
Reading and/or computer use
Group
Value
95% CI
Baseline vs 45-day Visit
-25.37
± 11.39
Baseline vs 90-day Visit
-34.87
± 17.72
Driving and/or watching TV
Group
Value
95% CI
Baseline vs 45-day Visit
-22.61
± 11.97
Baseline vs 90-day Visit
-23.07
± 19.32
General Activity
Group
Value
95% CI
Baseline vs 45-day Visit
-26.99
± 30.92
Baseline vs 90-day Visit
-54.71
± 15.02
Mood
Group
Value
95% CI
Baseline vs 45-day Visit
-22.57
± 9.20
Baseline vs 90-day Visit
-37.14
± 10.84
Sleep
Group
Value
95% CI
Baseline vs 45-day Visit
-23.95
± 30.32
Baseline vs 90-day Visit
-56.04
± 40.44
Enjoying life/ Relationship
Group
Value
95% CI
Baseline vs 45-day Visit
-26.46
± 13.94
Baseline vs 90-day Visit
-35.33
± 26.20
Time spent thinking about pain
Group
Value
95% CI
Baseline vs 45-day Visit
-19.56
± 34.50
Baseline vs 90-day Visit
-28.07
± 25.72
Percent Change From Pain Level Dimension Questions of the Ocular Pain Assessment Survey (OPAS)Secondary· Baseline vs day 45 visit and Baseline vs day 90 visit
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.
Most eye pain in 24 hours
Group
Value
95% CI
Baseline vs 45-Day Visit
-31.76
± 18.76
Baseline vs 90-Day Visit
-54.25
± 20.55
Least eye pain in 24 hours
Group
Value
95% CI
Baseline vs 45-Day Visit
-12.14
± 22.67
Baseline vs 90-Day Visit
-37.69
± 25.46
Average eye pain in 24 hours
Group
Value
95% CI
Baseline vs 45-Day Visit
-30.43
± 20.17
Baseline vs 90-Day Visit
-46.08
± 21.35
Most eye pain in 2 weeks
Group
Value
95% CI
Baseline vs 45-Day Visit
-22.89
± 18.43
Baseline vs 90-Day Visit
-43.73
± 16.57
Least eye pain in 2 weeks
Group
Value
95% CI
Baseline vs 45-Day Visit
-19.75
± 25.93
Baseline vs 90-Day Visit
-37.50
± 26.93
Average eye pain in 2 weeks
Group
Value
95% CI
Baseline vs 45-Day Visit
-24.77
± 22.18
Baseline vs 90-Day Visit
-46.90
± 20.85
Overall Percent Change on Impact of Dry Eye in Everyday Life (IDEEL)Secondary· Baseline vs day 45 visit and Baseline vs day 90 visit
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.
Daily Activities
Group
Value
95% CI
Baseline vs 45 Day Visit
16.14
± 23.72
Baseline vs 90 Day Visit
21.83
± 17.93
Feelings
Group
Value
95% CI
Baseline vs 45 Day Visit
17.06
± 17.38
Baseline vs 90 Day Visit
40.73
± 38.43
Work
Group
Value
95% CI
Baseline vs 45 Day Visit
46.91
± 17.82
Baseline vs 90 Day Visit
48.80
± 40.45
Change in the Intraocular Pressure (IOP) Measured in Each Visit.Secondary· Baseline vs day 45 visit and Baseline vs day 90 visit
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.
Group
Value
95% CI
Baseline vs 45 Day Visit
-0.18
± 1.10
Baseline vs 90 Day Visit
-0.43
± 0.92
Number of Participants With Adverse Events (Safety)Secondary· 90 days
For safety analyses during the study, patient-reported adverse events that developed after intranasal neurostimulation were recorded.
Migraine Attacks
Group
Value
95% CI
All Patients
2
Increased Eye Pain
Group
Value
95% CI
All Patients
1
Increased Facial Pain
Group
Value
95% CI
All Patients
1
Sinus Irritation and Pain
Group
Value
95% CI
All Patients
1
Sinus Infection
Group
Value
95% CI
All Patients
1
Excessive Tearing
Group
Value
95% CI
All Patients
1
Pain in the nose
Group
Value
95% CI
All Patients
2
Number of Participants With Adverse Events (Tolerability)Secondary· 90 days
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.
Eye Itching
Group
Value
95% CI
All Patients
2
Burning sensation
Group
Value
95% CI
All Patients
3
Foreign Body Sensation
Group
Value
95% CI
All Patients
2
Sneezing
Group
Value
95% CI
All Patients
2
Forehead Throbbing
Group
Value
95% CI
All Patients
1
Adverse events — posted to ClinicalTrials.gov
Time frame: 90 days.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
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Sponsor: as reported to ClinicalTrials.gov by Tufts Medical Center
Last refreshed: 24 August 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03674892.