Trial Outcomes & Findings for Safety and Efficacy of TrueTear™ for the Treatment of Meibomian Gland Disease (NCT NCT03226769)
NCT ID: NCT03226769
Last Updated: 2020-10-30
Results Overview
MGD impact questionnaire includes 10 questions about the impacts a participant may experience associated with MGD. Participants were asked to rate how much they have been affected by MGD symptoms in past 7 days. Question/s (Qs) 1-6 (computer usage, reading, leisure activities, social activities, driving and outdoor activities) were rated on a scale of 1=no difficulty to 5=a lot of difficulty. Q7 (frequency of outdoor activities) was rated on scale of 1=never to 5=all the time. If participants did not experience a particular impact, they chose 0=NA for Qs 1-7. Q8 (time spent to take care of eyes) was rated on scale 0-4, where 0=no time at all to 4=a lot of time, Qs 9-10 (bothered with amount of time taking care of eyes and bothered by appearance) were rated on scale 0-4, with 0=not at all bothered to 4=very bothered. Higher scores represented greater impact. A negative change from Baseline indicates improvement.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
57 participants
Primary outcome timeframe
Baseline (Day 0) to Day 30
Results posted on
2020-10-30
Participant Flow
Participant milestones
| Measure |
Thermalon
Participants received application of Thermalon dry eye compress on Days 0 and 7 followed by daily use as per label instructions.
|
TrueTear™
Participants received TrueTear™ device intranasally for approximately 8 minutes on Day 0, for approximately 3 minutes on Day 7 followed by daily use of TrueTear™ per participant guide.
|
|---|---|---|
|
Overall Study
STARTED
|
29
|
28
|
|
Overall Study
COMPLETED
|
29
|
27
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Thermalon
Participants received application of Thermalon dry eye compress on Days 0 and 7 followed by daily use as per label instructions.
|
TrueTear™
Participants received TrueTear™ device intranasally for approximately 8 minutes on Day 0, for approximately 3 minutes on Day 7 followed by daily use of TrueTear™ per participant guide.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Safety and Efficacy of TrueTear™ for the Treatment of Meibomian Gland Disease
Baseline characteristics by cohort
| Measure |
Thermalon
n=29 Participants
Participants received application of Thermalon dry eye compress on Days 0 and 7 followed by daily use as per label instructions.
|
TrueTear™
n=28 Participants
Participants received TrueTear™ device intranasally for approximately 8 minutes on Day 0, for approximately 3 minutes on Day 7 followed by daily use of TrueTear™ per participant guide.
|
Total
n=57 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63.2 years
STANDARD_DEVIATION 12.16 • n=5 Participants
|
63.8 years
STANDARD_DEVIATION 13.91 • n=7 Participants
|
63.5 years
STANDARD_DEVIATION 12.94 • n=5 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
29 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
27 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Meibomian Gland Dysfunction (MGD) Impact Questionnaire Score
Computer Usage
|
2.3 score on a scale
n=5 Participants
|
2.0 score on a scale
n=7 Participants
|
2.1 score on a scale
n=5 Participants
|
|
Meibomian Gland Dysfunction (MGD) Impact Questionnaire Score
Reading
|
2.7 score on a scale
n=5 Participants
|
2.0 score on a scale
n=7 Participants
|
2.3 score on a scale
n=5 Participants
|
|
Meibomian Gland Dysfunction (MGD) Impact Questionnaire Score
Leisure Activities
|
2.5 score on a scale
n=5 Participants
|
2.2 score on a scale
n=7 Participants
|
2.3 score on a scale
n=5 Participants
|
|
Meibomian Gland Dysfunction (MGD) Impact Questionnaire Score
Social Activities
|
1.4 score on a scale
n=5 Participants
|
1.7 score on a scale
n=7 Participants
|
1.5 score on a scale
n=5 Participants
|
|
Meibomian Gland Dysfunction (MGD) Impact Questionnaire Score
Driving
|
2.0 score on a scale
n=5 Participants
|
2.1 score on a scale
n=7 Participants
|
2.0 score on a scale
n=5 Participants
|
|
Meibomian Gland Dysfunction (MGD) Impact Questionnaire Score
Outdoor Activities
|
1.9 score on a scale
n=5 Participants
|
1.6 score on a scale
n=7 Participants
|
1.7 score on a scale
n=5 Participants
|
|
Meibomian Gland Dysfunction (MGD) Impact Questionnaire Score
Frequency of Outdoor Activities
|
2.0 score on a scale
n=5 Participants
|
1.8 score on a scale
n=7 Participants
|
1.9 score on a scale
n=5 Participants
|
|
Meibomian Gland Dysfunction (MGD) Impact Questionnaire Score
Time Spent to Take Care of Eyes
|
1.7 score on a scale
n=5 Participants
|
1.4 score on a scale
n=7 Participants
|
1.5 score on a scale
n=5 Participants
|
|
Meibomian Gland Dysfunction (MGD) Impact Questionnaire Score
Bothered With Amount of Time Taking Care of Eyes
|
1.3 score on a scale
n=5 Participants
|
0.9 score on a scale
n=7 Participants
|
1.1 score on a scale
n=5 Participants
|
|
Meibomian Gland Dysfunction (MGD) Impact Questionnaire Score
Bothered by Appearance
|
1.1 score on a scale
n=5 Participants
|
1.2 score on a scale
n=7 Participants
|
1.1 score on a scale
n=5 Participants
|
|
MGD Symptoms Questionnaire Score
Red Eyes
|
1.3 score on a scale
n=5 Participants
|
1.2 score on a scale
n=7 Participants
|
1.2 score on a scale
n=5 Participants
|
|
MGD Symptoms Questionnaire Score
Blurred Vision
|
1.4 score on a scale
n=5 Participants
|
1.2 score on a scale
n=7 Participants
|
1.3 score on a scale
n=5 Participants
|
|
MGD Symptoms Questionnaire Score
Dry Eyes
|
2.6 score on a scale
n=5 Participants
|
2.5 score on a scale
n=7 Participants
|
2.5 score on a scale
n=5 Participants
|
|
MGD Symptoms Questionnaire Score
Itchy Eyes
|
2.2 score on a scale
n=5 Participants
|
1.6 score on a scale
n=7 Participants
|
1.9 score on a scale
n=5 Participants
|
|
MGD Symptoms Questionnaire Score
Burning Eyes
|
1.5 score on a scale
n=5 Participants
|
1.5 score on a scale
n=7 Participants
|
1.5 score on a scale
n=5 Participants
|
|
MGD Symptoms Questionnaire Score
Gritty Eyes
|
2.0 score on a scale
n=5 Participants
|
1.7 score on a scale
n=7 Participants
|
1.8 score on a scale
n=5 Participants
|
|
MGD Symptoms Questionnaire Score
Painful Eyes
|
1.0 score on a scale
n=5 Participants
|
0.9 score on a scale
n=7 Participants
|
0.9 score on a scale
n=5 Participants
|
|
MGD Symptoms Questionnaire Score
Watery Eyes
|
1.3 score on a scale
n=5 Participants
|
1.3 score on a scale
n=7 Participants
|
1.3 score on a scale
n=5 Participants
|
|
MGD Symptoms Questionnaire Score
Swollen Eyelids
|
0.6 score on a scale
n=5 Participants
|
0.5 score on a scale
n=7 Participants
|
0.5 score on a scale
n=5 Participants
|
|
MGD Symptoms Questionnaire Score
Red Eyelids
|
0.9 score on a scale
n=5 Participants
|
1.0 score on a scale
n=7 Participants
|
0.9 score on a scale
n=5 Participants
|
|
MGD Symptoms Questionnaire Score
Crusty Eyelids
|
1.0 score on a scale
n=5 Participants
|
1.1 score on a scale
n=7 Participants
|
1.0 score on a scale
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 0) to Day 30Population: ITT population included all randomized participants. Overall number of participants analyzed is the number of participants with data available for analyses.
MGD impact questionnaire includes 10 questions about the impacts a participant may experience associated with MGD. Participants were asked to rate how much they have been affected by MGD symptoms in past 7 days. Question/s (Qs) 1-6 (computer usage, reading, leisure activities, social activities, driving and outdoor activities) were rated on a scale of 1=no difficulty to 5=a lot of difficulty. Q7 (frequency of outdoor activities) was rated on scale of 1=never to 5=all the time. If participants did not experience a particular impact, they chose 0=NA for Qs 1-7. Q8 (time spent to take care of eyes) was rated on scale 0-4, where 0=no time at all to 4=a lot of time, Qs 9-10 (bothered with amount of time taking care of eyes and bothered by appearance) were rated on scale 0-4, with 0=not at all bothered to 4=very bothered. Higher scores represented greater impact. A negative change from Baseline indicates improvement.
Outcome measures
| Measure |
Thermalon
n=29 Participants
Participants received application of Thermalon dry eye compress on Days 0 and 7 followed by daily use as per label instructions.
|
TrueTear™
n=27 Participants
Participants received TrueTear™ device intranasally for approximately 8 minutes on Day 0, for approximately 3 minutes on Day 7 followed by daily use of TrueTear™ per participant guide.
|
|---|---|---|
|
Change From Baseline in Meibomian Gland Dysfunction (MGD) Impact Questionnaire Score
Computer Usage
|
-0.4 score on scale
Standard Deviation 0.86
|
-0.3 score on scale
Standard Deviation 0.83
|
|
Change From Baseline in Meibomian Gland Dysfunction (MGD) Impact Questionnaire Score
Reading
|
-0.4 score on scale
Standard Deviation 0.90
|
-0.2 score on scale
Standard Deviation 0.79
|
|
Change From Baseline in Meibomian Gland Dysfunction (MGD) Impact Questionnaire Score
Leisure Activities
|
-0.3 score on scale
Standard Deviation 0.89
|
-0.4 score on scale
Standard Deviation 0.89
|
|
Change From Baseline in Meibomian Gland Dysfunction (MGD) Impact Questionnaire Score
Social Activities
|
-0.2 score on scale
Standard Deviation 0.87
|
-0.2 score on scale
Standard Deviation 0.79
|
|
Change From Baseline in Meibomian Gland Dysfunction (MGD) Impact Questionnaire Score
Driving
|
-0.1 score on scale
Standard Deviation 0.92
|
-0.2 score on scale
Standard Deviation 1.05
|
|
Change From Baseline in Meibomian Gland Dysfunction (MGD) Impact Questionnaire Score
Outdoor Activities
|
-0.3 score on scale
Standard Deviation 0.81
|
-0.1 score on scale
Standard Deviation 0.85
|
|
Change From Baseline in Meibomian Gland Dysfunction (MGD) Impact Questionnaire Score
Frequency of Outdoor Activities
|
-0.2 score on scale
Standard Deviation 0.69
|
-0.1 score on scale
Standard Deviation 0.83
|
|
Change From Baseline in Meibomian Gland Dysfunction (MGD) Impact Questionnaire Score
Time Spent to Take Care of Eyes
|
-0.1 score on scale
Standard Deviation 0.83
|
0.1 score on scale
Standard Deviation 0.91
|
|
Change From Baseline in Meibomian Gland Dysfunction (MGD) Impact Questionnaire Score
Bothered With Amount of Time Taking Care of Eyes
|
-0.4 score on scale
Standard Deviation 1.01
|
0.0 score on scale
Standard Deviation 1.09
|
|
Change From Baseline in Meibomian Gland Dysfunction (MGD) Impact Questionnaire Score
Bothered by Appearance
|
-0.3 score on scale
Standard Deviation 0.77
|
-0.1 score on scale
Standard Deviation 0.82
|
PRIMARY outcome
Timeframe: Baseline (Day 0) to Day 30Population: ITT population included all randomized participants. Overall number of participants analyzed is the number of participants with data available for analyses.
MGD symptom questionnaire included 11 questions about the symptoms the participant may experience associated with MGD. The participant was asked to rate how much they experienced certain MGD symptoms and the severity of the symptoms over the past 24 hours on a scale of 0 to 4, where 0 = not at all, 1 = a little, 2 = somewhat, 3=quite a bit, 4 = very. A higher score within each question represented increased severity of the indicated symptom. A negative change from baseline indicates improvement.
Outcome measures
| Measure |
Thermalon
n=29 Participants
Participants received application of Thermalon dry eye compress on Days 0 and 7 followed by daily use as per label instructions.
|
TrueTear™
n=27 Participants
Participants received TrueTear™ device intranasally for approximately 8 minutes on Day 0, for approximately 3 minutes on Day 7 followed by daily use of TrueTear™ per participant guide.
|
|---|---|---|
|
Change From Baseline in MGD Symptoms Questionnaire Score
Watery Eyes
|
0.0 score on a scale
Standard Deviation 1.20
|
-0.1 score on a scale
Standard Deviation 0.75
|
|
Change From Baseline in MGD Symptoms Questionnaire Score
Red Eyes
|
-0.2 score on a scale
Standard Deviation 0.76
|
-0.1 score on a scale
Standard Deviation 0.83
|
|
Change From Baseline in MGD Symptoms Questionnaire Score
Blurred Vision
|
-0.2 score on a scale
Standard Deviation 0.85
|
-0.2 score on a scale
Standard Deviation 0.80
|
|
Change From Baseline in MGD Symptoms Questionnaire Score
Dry Eyes
|
-0.3 score on a scale
Standard Deviation 1.04
|
-0.5 score on a scale
Standard Deviation 0.85
|
|
Change From Baseline in MGD Symptoms Questionnaire Score
Itchy Eyes
|
-0.8 score on a scale
Standard Deviation 1.23
|
-0.3 score on a scale
Standard Deviation 0.99
|
|
Change From Baseline in MGD Symptoms Questionnaire Score
Burning Eyes
|
-0.2 score on a scale
Standard Deviation 0.77
|
-0.5 score on a scale
Standard Deviation 0.89
|
|
Change From Baseline in MGD Symptoms Questionnaire Score
Gritty Eyes
|
-0.2 score on a scale
Standard Deviation 0.99
|
-0.4 score on a scale
Standard Deviation 0.88
|
|
Change From Baseline in MGD Symptoms Questionnaire Score
Painful Eyes
|
-0.4 score on a scale
Standard Deviation 0.87
|
-0.1 score on a scale
Standard Deviation 0.62
|
|
Change From Baseline in MGD Symptoms Questionnaire Score
Swollen Eyelids
|
0.0 score on a scale
Standard Deviation 0.93
|
0.3 score on a scale
Standard Deviation 0.66
|
|
Change From Baseline in MGD Symptoms Questionnaire Score
Red Eyelids
|
0.0 score on a scale
Standard Deviation 0.78
|
-0.1 score on a scale
Standard Deviation 0.46
|
|
Change From Baseline in MGD Symptoms Questionnaire Score
Crusty Eyelids
|
0.1 score on a scale
Standard Deviation 0.75
|
-0.4 score on a scale
Standard Deviation 0.74
|
Adverse Events
Thermalon
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
TrueTear™
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Thermalon
n=29 participants at risk
Participants received application of Thermalon dry eye compress on Days 0 and 7 followed by daily use as per label instructions.
|
TrueTear™
n=28 participants at risk
Participants received TrueTear™ device intranasally for approximately 8 minutes on Day 0, for approximately 3 minutes on Day 7 followed by daily use of TrueTear™ per participant guide.
|
|---|---|---|
|
Eye disorders
Vision blurred
|
6.9%
2/29 • Up to Day 30
|
0.00%
0/28 • Up to Day 30
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/29 • Up to Day 30
|
7.1%
2/28 • Up to Day 30
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER