Safety and Efficacy of TrueTear™ for the Treatment of Meibomian Gland Disease
Sponsor
Allergan (Industry)
Overall Status
Completed
CT.gov ID
NCT03226769
Collaborator
(none)
57
1
2
4.6
12.5
Study Details
Study Description
Brief Summary
This study will compare the safety and efficacy of TrueTear™ to standardized moist heat compress (Thermalon® Dry Eye Compress) for the treatment of Meibomian Gland Disease (MGD).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Actual Enrollment
:
57 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Prospective, Open-Label, Randomized, Proof of Concept Study Exploring Application of TrueTear™ for the Treatment of Meibomian Gland Disease
Actual Study Start Date
:
Jul 26, 2017
Actual Primary Completion Date
:
Dec 12, 2017
Actual Study Completion Date
:
Dec 12, 2017
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Thermalon Participants received application of Thermalon dry eye compress on Days 0 and 7 followed by daily use as per label instructions. |
Device: Thermalon Dry Eye Compress
Application of Thermalon Dry Eye Compress at Day 0, Day 7 and daily use as per label instructions.
|
| Experimental: 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. |
Device: TrueTear™
Intranasal application of TrueTear™ device for approximately 8 minutes at Day 0, for approximately 3 minutes at Day 7 and then daily use of TrueTear™ per participant guide.
|
Outcome Measures
Primary Outcome Measures
- Change From Baseline in Meibomian Gland Dysfunction (MGD) Impact Questionnaire Score [Baseline (Day 0) to Day 30]
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.
- Change From Baseline in MGD Symptoms Questionnaire Score [Baseline (Day 0) to Day 30]
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.
Eligibility Criteria
Criteria
Ages Eligible for Study:
22 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Dry eye disease or Meibomian Gland Disease as evaluated by Standard Participant Evaluation for Dryness (SPEED) score, Schirmer test, Tear film breakup time and other applicable objective measures at the Screening and Baseline Visits.
-
Use of an artificial tear product, lid hygiene, omega-3 supplementation, antibiotics for the treatment of dry eye disease or Meibomian Gland Disease within one year of the Screening Visit.
Exclusion Criteria:
-
Chronic or recurrent epistaxis, coagulation disorders or other conditions that may increase the risk of bleeding.
-
History of nasal or sinus surgery.
-
Vascularized polyp, deviated septum or severe nasal airway obstruction at the Screening visit.
-
Intraocular and extraocular surgery in either eye within three months of the Screening Visit or refractive surgery within twelve months of the Screening Visit.
-
Cardiac demand pacemaker, implanted defibrillator, or other active implanted metallic or active implanted electronic device in the head.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Andover Eye Associates | Andover | Massachusetts | United States | 01810 |
Sponsors and Collaborators
- Allergan
Investigators
- Principal Investigator: Gail Torkildsen, mdlasik@comcast.net
Study Documents (Full-Text)
More Information
Publications
None provided.Responsible Party:
Allergan
ClinicalTrials.gov Identifier:
NCT03226769
Other Study ID Numbers:
- OCUN-023
First Posted:
Jul 24, 2017
Last Update Posted:
Oct 30, 2020
Last Verified:
Oct 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Thermalon | TrueTear™ |
|---|---|---|
| Arm/Group Description | Participants received application of Thermalon dry eye compress on Days 0 and 7 followed by daily use as per label instructions. | 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. |
| Period Title: Overall Study | ||
| STARTED | 29 | 28 |
| COMPLETED | 29 | 27 |
| NOT COMPLETED | 0 | 1 |
Baseline Characteristics
| Arm/Group Title | Thermalon | TrueTear™ | Total |
|---|---|---|---|
| Arm/Group Description | Participants received application of Thermalon dry eye compress on Days 0 and 7 followed by daily use as per label instructions. | 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 of all reporting groups |
| Overall Participants | 29 | 28 | 57 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
63.2
(12.16)
|
63.8
(13.91)
|
63.5
(12.94)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
18
62.1%
|
19
67.9%
|
37
64.9%
|
| Male |
11
37.9%
|
9
32.1%
|
20
35.1%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |||
| Hispanic or Latino |
0
0%
|
2
7.1%
|
2
3.5%
|
| Not Hispanic or Latino |
29
100%
|
26
92.9%
|
55
96.5%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
| Race (NIH/OMB) (Count of Participants) | |||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
| Asian |
0
0%
|
0
0%
|
0
0%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
2
6.9%
|
0
0%
|
2
3.5%
|
| White |
27
93.1%
|
28
100%
|
55
96.5%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
| Meibomian Gland Dysfunction (MGD) Impact Questionnaire Score (score on a scale) [Mean (Full Range) ] | |||
| Computer Usage |
2.3
|
2.0
|
2.1
|
| Reading |
2.7
|
2.0
|
2.3
|
| Leisure Activities |
2.5
|
2.2
|
2.3
|
| Social Activities |
1.4
|
1.7
|
1.5
|
| Driving |
2.0
|
2.1
|
2.0
|
| Outdoor Activities |
1.9
|
1.6
|
1.7
|
| Frequency of Outdoor Activities |
2.0
|
1.8
|
1.9
|
| Time Spent to Take Care of Eyes |
1.7
|
1.4
|
1.5
|
| Bothered With Amount of Time Taking Care of Eyes |
1.3
|
0.9
|
1.1
|
| Bothered by Appearance |
1.1
|
1.2
|
1.1
|
| MGD Symptoms Questionnaire Score (score on a scale) [Mean (Full Range) ] | |||
| Red Eyes |
1.3
|
1.2
|
1.2
|
| Blurred Vision |
1.4
|
1.2
|
1.3
|
| Dry Eyes |
2.6
|
2.5
|
2.5
|
| Itchy Eyes |
2.2
|
1.6
|
1.9
|
| Burning Eyes |
1.5
|
1.5
|
1.5
|
| Gritty Eyes |
2.0
|
1.7
|
1.8
|
| Painful Eyes |
1.0
|
0.9
|
0.9
|
| Watery Eyes |
1.3
|
1.3
|
1.3
|
| Swollen Eyelids |
0.6
|
0.5
|
0.5
|
| Red Eyelids |
0.9
|
1.0
|
0.9
|
| Crusty Eyelids |
1.0
|
1.1
|
1.0
|
Outcome Measures
| Title | Change From Baseline in Meibomian Gland Dysfunction (MGD) Impact Questionnaire Score |
|---|---|
| Description | 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. |
| Time Frame | Baseline (Day 0) to Day 30 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population included all randomized participants. Overall number of participants analyzed is the number of participants with data available for analyses. |
| Arm/Group Title | Thermalon | TrueTear™ |
|---|---|---|
| Arm/Group Description | Participants received application of Thermalon dry eye compress on Days 0 and 7 followed by daily use as per label instructions. | 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. |
| Measure Participants | 29 | 27 |
| Computer Usage |
-0.4
(0.86)
|
-0.3
(0.83)
|
| Reading |
-0.4
(0.90)
|
-0.2
(0.79)
|
| Leisure Activities |
-0.3
(0.89)
|
-0.4
(0.89)
|
| Social Activities |
-0.2
(0.87)
|
-0.2
(0.79)
|
| Driving |
-0.1
(0.92)
|
-0.2
(1.05)
|
| Outdoor Activities |
-0.3
(0.81)
|
-0.1
(0.85)
|
| Frequency of Outdoor Activities |
-0.2
(0.69)
|
-0.1
(0.83)
|
| Time Spent to Take Care of Eyes |
-0.1
(0.83)
|
0.1
(0.91)
|
| Bothered With Amount of Time Taking Care of Eyes |
-0.4
(1.01)
|
0.0
(1.09)
|
| Bothered by Appearance |
-0.3
(0.77)
|
-0.1
(0.82)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Thermalon, TrueTear™ |
|---|---|---|
| Comments | Computer Usage | |
| Type of Statistical Test | Other | |
| Comments | The null hypothesis is that there is no difference between the two devices, TrueTear™ and Thermalon. | |
| Statistical Test of Hypothesis | p-Value | 0.9788 |
| Comments | Statistically significant (p < 0.05) and trending significant (p < 0.10) for within-group or between-group changes from baseline at Day 30. Between-group P-value was calculated using Wilcoxon rank-sum test. | |
| Method | Wilcoxon rank-sum test | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Thermalon, TrueTear™ |
|---|---|---|
| Comments | Reading | |
| Type of Statistical Test | Other | |
| Comments | The null hypothesis is that there is no difference between the two devices, TrueTear™ and Thermalon. | |
| Statistical Test of Hypothesis | p-Value | 0.6571 |
| Comments | Statistically significant (p < 0.05) and trending significant (p < 0.10) for within-group or between-group changes from baseline at Day 30. Between-group P-value was calculated using Wilcoxon rank-sum test. | |
| Method | Wilcoxon rank-sum test | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Thermalon, TrueTear™ |
|---|---|---|
| Comments | Leisure Activities | |
| Type of Statistical Test | Other | |
| Comments | The null hypothesis is that there is no difference between the two devices, TrueTear™ and Thermalon. | |
| Statistical Test of Hypothesis | p-Value | 0.4710 |
| Comments | Statistically significant (p < 0.05) and trending significant (p < 0.10) for within-group or between-group changes from baseline at Day 30. Between-group P-value was calculated using Wilcoxon rank-sum test. | |
| Method | Wilcoxon rank-sum test | |
| Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Thermalon, TrueTear™ |
|---|---|---|
| Comments | Social Activities | |
| Type of Statistical Test | Other | |
| Comments | The null hypothesis is that there is no difference between the two devices, TrueTear™ and Thermalon. | |
| Statistical Test of Hypothesis | p-Value | 0.7360 |
| Comments | Statistically significant (p < 0.05) and trending significant (p < 0.10) for within-group or between-group changes from baseline at Day 30. Between-group P-value was calculated using Wilcoxon rank-sum test. | |
| Method | Wilcoxon rank-sum test | |
| Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Thermalon, TrueTear™ |
|---|---|---|
| Comments | Driving | |
| Type of Statistical Test | Other | |
| Comments | The null hypothesis is that there is no difference between the two devices, TrueTear™ and Thermalon. | |
| Statistical Test of Hypothesis | p-Value | 0.4999 |
| Comments | Statistically significant (p < 0.05) and trending significant (p < 0.10) for within-group or between-group changes from baseline at Day 30. Between-group P-value was calculated using Wilcoxon rank-sum test. | |
| Method | Wilcoxon rank-sum test | |
| Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Thermalon, TrueTear™ |
|---|---|---|
| Comments | Outdoor Activities | |
| Type of Statistical Test | Other | |
| Comments | The null hypothesis is that there is no difference between the two devices, TrueTear™ and Thermalon. | |
| Statistical Test of Hypothesis | p-Value | 0.1159 |
| Comments | Statistically significant (p < 0.05) and trending significant (p < 0.10) for within-group or between-group changes from baseline at Day 30. Between-group P-value was calculated using Wilcoxon rank-sum test. | |
| Method | Wilcoxon rank-sum test | |
| Comments | ||
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | Thermalon, TrueTear™ |
|---|---|---|
| Comments | Frequency of Outdoor Activities | |
| Type of Statistical Test | Other | |
| Comments | The null hypothesis is that there is no difference between the two devices, TrueTear™ and Thermalon. | |
| Statistical Test of Hypothesis | p-Value | 0.4567 |
| Comments | Statistically significant (p < 0.05) and trending significant (p < 0.10) for within-group or between-group changes from baseline at Day 30. Between-group P-value was calculated using Wilcoxon rank-sum test. | |
| Method | Wilcoxon rank-sum test | |
| Comments | ||
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | Thermalon, TrueTear™ |
|---|---|---|
| Comments | Time Spent to Take Care of Eyes | |
| Type of Statistical Test | Other | |
| Comments | The null hypothesis is that there is no difference between the two devices, TrueTear™ and Thermalon. | |
| Statistical Test of Hypothesis | p-Value | 0.3439 |
| Comments | Statistically significant (p < 0.05) and trending significant (p < 0.10) for within-group or between-group changes from baseline at Day 30. Between-group P-value was calculated using Wilcoxon rank-sum test. | |
| Method | Wilcoxon rank-sum test | |
| Comments | ||
Statistical Analysis 9
| Statistical Analysis Overview | Comparison Group Selection | Thermalon, TrueTear™ |
|---|---|---|
| Comments | Bothered With Amount of Time Taking Care of Eyes | |
| Type of Statistical Test | Other | |
| Comments | The null hypothesis is that there is no difference between the two devices, TrueTear™ and Thermalon. | |
| Statistical Test of Hypothesis | p-Value | 0.3331 |
| Comments | Statistically significant (p < 0.05) and trending significant (p < 0.10) for within-group or between-group changes from baseline at Day 30. Between-group P-value was calculated using Wilcoxon rank-sum test. | |
| Method | Wilcoxon rank-sum test | |
| Comments | ||
Statistical Analysis 10
| Statistical Analysis Overview | Comparison Group Selection | Thermalon, TrueTear™ |
|---|---|---|
| Comments | Bothered by Appearance | |
| Type of Statistical Test | Other | |
| Comments | The null hypothesis is that there is no difference between the two devices, TrueTear™ and Thermalon. | |
| Statistical Test of Hypothesis | p-Value | 0.4774 |
| Comments | Statistically significant (p < 0.05) and trending significant (p < 0.10) for within-group or between-group changes from baseline at Day 30. Between-group P-value was calculated using Wilcoxon rank-sum test. | |
| Method | Wilcoxon rank-sum test | |
| Comments | ||
| Title | Change From Baseline in MGD Symptoms Questionnaire Score |
|---|---|
| Description | 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. |
| Time Frame | Baseline (Day 0) to Day 30 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population included all randomized participants. Overall number of participants analyzed is the number of participants with data available for analyses. |
| Arm/Group Title | Thermalon | TrueTear™ |
|---|---|---|
| Arm/Group Description | Participants received application of Thermalon dry eye compress on Days 0 and 7 followed by daily use as per label instructions. | 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. |
| Measure Participants | 29 | 27 |
| Red Eyes |
-0.2
(0.76)
|
-0.1
(0.83)
|
| Blurred Vision |
-0.2
(0.85)
|
-0.2
(0.80)
|
| Dry Eyes |
-0.3
(1.04)
|
-0.5
(0.85)
|
| Itchy Eyes |
-0.8
(1.23)
|
-0.3
(0.99)
|
| Burning Eyes |
-0.2
(0.77)
|
-0.5
(0.89)
|
| Gritty Eyes |
-0.2
(0.99)
|
-0.4
(0.88)
|
| Painful Eyes |
-0.4
(0.87)
|
-0.1
(0.62)
|
| Watery Eyes |
0.0
(1.20)
|
-0.1
(0.75)
|
| Swollen Eyelids |
0.0
(0.93)
|
0.3
(0.66)
|
| Red Eyelids |
0.0
(0.78)
|
-0.1
(0.46)
|
| Crusty Eyelids |
0.1
(0.75)
|
-0.4
(0.74)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Thermalon, TrueTear™ |
|---|---|---|
| Comments | Red Eyes | |
| Type of Statistical Test | Other | |
| Comments | The null hypothesis is that there is no difference between the two devices, TrueTear™ and Thermalon. | |
| Statistical Test of Hypothesis | p-Value | 0.5457 |
| Comments | Statistically significant (p < 0.05) and trending significant (p < 0.10) for within-group or between-group changes from baseline at Day 30. Between-group P-value was calculated using Wilcoxon rank-sum test. | |
| Method | Wilcoxon rank-sum test | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Thermalon, TrueTear™ |
|---|---|---|
| Comments | Blurred Vision | |
| Type of Statistical Test | Other | |
| Comments | The null hypothesis is that there is no difference between the two devices, TrueTear™ and Thermalon. | |
| Statistical Test of Hypothesis | p-Value | 0.9786 |
| Comments | Statistically significant (p < 0.05) and trending significant (p < 0.10) for within-group or between-group changes from baseline at Day 30. Between-group P-value was calculated using Wilcoxon rank-sum test. | |
| Method | Wilcoxon rank-sum test | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Thermalon, TrueTear™ |
|---|---|---|
| Comments | Dry Eyes | |
| Type of Statistical Test | Other | |
| Comments | The null hypothesis is that there is no difference between the two devices, TrueTear™ and Thermalon. | |
| Statistical Test of Hypothesis | p-Value | 0.3894 |
| Comments | Statistically significant (p < 0.05) and trending significant (p < 0.10) for within-group or between-group changes from baseline at Day 30. Between-group P-value was calculated using Wilcoxon rank-sum test. | |
| Method | Wilcoxon rank-sum test | |
| Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Thermalon, TrueTear™ |
|---|---|---|
| Comments | Itchy Eyes | |
| Type of Statistical Test | Other | |
| Comments | The null hypothesis is that there is no difference between the two devices, TrueTear™ and Thermalon. | |
| Statistical Test of Hypothesis | p-Value | 0.0591 |
| Comments | Statistically significant (p < 0.05) and trending significant (p < 0.10) for within-group or between-group changes from baseline at Day 30. Between-group P-value was calculated using Wilcoxon rank-sum test. | |
| Method | Wilcoxon rank-sum test | |
| Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Thermalon, TrueTear™ |
|---|---|---|
| Comments | Burning Eyes | |
| Type of Statistical Test | Other | |
| Comments | The null hypothesis is that there is no difference between the two devices, TrueTear™ and Thermalon. | |
| Statistical Test of Hypothesis | p-Value | 0.1818 |
| Comments | Statistically significant (p < 0.05) and trending significant (p < 0.10) for within-group or between-group changes from baseline at Day 30. Between-group P-value was calculated using Wilcoxon rank-sum test. | |
| Method | Wilcoxon rank-sum test | |
| Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Thermalon, TrueTear™ |
|---|---|---|
| Comments | Gritty Eyes | |
| Type of Statistical Test | Other | |
| Comments | The null hypothesis is that there is no difference between the two devices, TrueTear™ and Thermalon. | |
| Statistical Test of Hypothesis | p-Value | 0.4284 |
| Comments | Statistically significant (p < 0.05) and trending significant (p < 0.10) for within-group or between-group changes from baseline at Day 30. Between-group P-value was calculated using Wilcoxon rank-sum test. | |
| Method | Wilcoxon rank-sum test | |
| Comments | ||
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | Thermalon, TrueTear™ |
|---|---|---|
| Comments | Painful Eyes | |
| Type of Statistical Test | Other | |
| Comments | The null hypothesis is that there is no difference between the two devices, TrueTear™ and Thermalon. | |
| Statistical Test of Hypothesis | p-Value | 0.1051 |
| Comments | Statistically significant (p < 0.05) and trending significant (p < 0.10) for within-group or between-group changes from baseline at Day 30. Between-group P-value was calculated using Wilcoxon rank-sum test. | |
| Method | Wilcoxon rank-sum test | |
| Comments | ||
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | Thermalon, TrueTear™ |
|---|---|---|
| Comments | Watery Eyes | |
| Type of Statistical Test | Other | |
| Comments | The null hypothesis is that there is no difference between the two devices, TrueTear™ and Thermalon. | |
| Statistical Test of Hypothesis | p-Value | 0.7998 |
| Comments | Statistically significant (p < 0.05) and trending significant (p < 0.10) for within-group or between-group changes from baseline at Day 30. Between-group P-value was calculated using Wilcoxon rank-sum test. | |
| Method | Wilcoxon rank-sum test | |
| Comments | ||
Statistical Analysis 9
| Statistical Analysis Overview | Comparison Group Selection | Thermalon, TrueTear™ |
|---|---|---|
| Comments | Swollen Eyelids | |
| Type of Statistical Test | Other | |
| Comments | The null hypothesis is that there is no difference between the two devices, TrueTear™ and Thermalon. | |
| Statistical Test of Hypothesis | p-Value | 0.1229 |
| Comments | Statistically significant (p < 0.05) and trending significant (p < 0.10) for within-group or between-group changes from baseline at Day 30. Between-group P-value was calculated using Wilcoxon rank-sum test. | |
| Method | Wilcoxon rank-sum test | |
| Comments | ||
Statistical Analysis 10
| Statistical Analysis Overview | Comparison Group Selection | Thermalon, TrueTear™ |
|---|---|---|
| Comments | Red Eyelids | |
| Type of Statistical Test | Other | |
| Comments | The null hypothesis is that there is no difference between the two devices, TrueTear™ and Thermalon. | |
| Statistical Test of Hypothesis | p-Value | 0.3907 |
| Comments | Statistically significant (p < 0.05) and trending significant (p < 0.10) for within-group or between-group changes from baseline at Day 30. Between-group P-value was calculated using Wilcoxon rank-sum test. | |
| Method | Wilcoxon rank-sum test | |
| Comments | ||
Statistical Analysis 11
| Statistical Analysis Overview | Comparison Group Selection | Thermalon, TrueTear™ |
|---|---|---|
| Comments | Crusty Eyelids | |
| Type of Statistical Test | Other | |
| Comments | The null hypothesis is that there is no difference between the two devices, TrueTear™ and Thermalon. | |
| Statistical Test of Hypothesis | p-Value | 0.0336 |
| Comments | Statistically significant (p < 0.05) and trending significant (p < 0.10) for within-group or between-group changes from baseline at Day 30. Between-group P-value was calculated using Wilcoxon rank-sum test. | |
| Method | Wilcoxon rank-sum test | |
| Comments | ||
Adverse Events
| Time Frame | Up to Day 30 | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | Thermalon | TrueTear™ | ||
| Arm/Group Description | Participants received application of Thermalon dry eye compress on Days 0 and 7 followed by daily use as per label instructions. | 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. | ||
All Cause Mortality |
||||
| Thermalon | TrueTear™ | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/29 (0%) | 0/28 (0%) | ||
Serious Adverse Events |
||||
| Thermalon | TrueTear™ | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/29 (0%) | 0/28 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Thermalon | TrueTear™ | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 2/29 (6.9%) | 2/28 (7.1%) | ||
| Eye disorders | ||||
| Vision blurred | 2/29 (6.9%) | 0/28 (0%) | ||
| Respiratory, thoracic and mediastinal disorders | ||||
| Nasal congestion | 0/29 (0%) | 2/28 (7.1%) | ||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
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.
Results Point of Contact
| Name/Title | Therapeutic Area, Head |
|---|---|
| Organization | Allergan |
| Phone | 714-246-4500 |
| clinicaltrials@allergan.com |
Responsible Party:
Allergan
ClinicalTrials.gov Identifier:
NCT03226769
Other Study ID Numbers:
- OCUN-023
First Posted:
Jul 24, 2017
Last Update Posted:
Oct 30, 2020
Last Verified:
Oct 1, 2020