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
Enrollment
1
Location
2
Arms
4.6
Actual Duration (Months)
12.5
Patients Per Site Per Month

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 DiseaseIntervention/TreatmentPhase
  • Device: TrueTear™
  • Device: Thermalon Dry Eye Compress
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

ArmIntervention/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

  1. 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.

  2. 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

SiteCityStateCountryPostal Code
1Andover Eye AssociatesAndoverMassachusettsUnited States01810

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 TitleThermalonTrueTear™
Arm/Group DescriptionParticipants 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
STARTED2928
COMPLETED2927
NOT COMPLETED01

Baseline Characteristics

Arm/Group TitleThermalonTrueTear™Total
Arm/Group DescriptionParticipants 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 Participants292857
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

1. Primary Outcome
TitleChange From Baseline in Meibomian Gland Dysfunction (MGD) Impact Questionnaire Score
DescriptionMGD 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 FrameBaseline (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 TitleThermalonTrueTear™
Arm/Group DescriptionParticipants 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 Participants2927
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 Hypothesisp-Value0.9788
CommentsStatistically 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.
MethodWilcoxon 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 Hypothesisp-Value0.6571
CommentsStatistically 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.
MethodWilcoxon 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 Hypothesisp-Value0.4710
CommentsStatistically 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.
MethodWilcoxon 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 Hypothesisp-Value0.7360
CommentsStatistically 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.
MethodWilcoxon 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 Hypothesisp-Value0.4999
CommentsStatistically 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.
MethodWilcoxon 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 Hypothesisp-Value0.1159
CommentsStatistically 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.
MethodWilcoxon 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 Hypothesisp-Value0.4567
CommentsStatistically 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.
MethodWilcoxon 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 Hypothesisp-Value0.3439
CommentsStatistically 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.
MethodWilcoxon 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 Hypothesisp-Value0.3331
CommentsStatistically 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.
MethodWilcoxon 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 Hypothesisp-Value0.4774
CommentsStatistically 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.
MethodWilcoxon rank-sum test
Comments
2. Primary Outcome
TitleChange From Baseline in MGD Symptoms Questionnaire Score
DescriptionMGD 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 FrameBaseline (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 TitleThermalonTrueTear™
Arm/Group DescriptionParticipants 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 Participants2927
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 Hypothesisp-Value0.5457
CommentsStatistically 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.
MethodWilcoxon 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 Hypothesisp-Value0.9786
CommentsStatistically 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.
MethodWilcoxon 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 Hypothesisp-Value0.3894
CommentsStatistically 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.
MethodWilcoxon 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 Hypothesisp-Value0.0591
CommentsStatistically 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.
MethodWilcoxon 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 Hypothesisp-Value0.1818
CommentsStatistically 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.
MethodWilcoxon 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 Hypothesisp-Value0.4284
CommentsStatistically 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.
MethodWilcoxon 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 Hypothesisp-Value0.1051
CommentsStatistically 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.
MethodWilcoxon 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 Hypothesisp-Value0.7998
CommentsStatistically 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.
MethodWilcoxon 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 Hypothesisp-Value0.1229
CommentsStatistically 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.
MethodWilcoxon 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 Hypothesisp-Value0.3907
CommentsStatistically 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.
MethodWilcoxon 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 Hypothesisp-Value0.0336
CommentsStatistically 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.
MethodWilcoxon rank-sum test
Comments

Adverse Events

Time FrameUp to Day 30
Adverse Event Reporting Description
Arm/Group TitleThermalonTrueTear™
Arm/Group DescriptionParticipants 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
ThermalonTrueTear™
Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total0/29 (0%) 0/28 (0%)
Serious Adverse Events
ThermalonTrueTear™
Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total0/29 (0%) 0/28 (0%)
Other (Not Including Serious) Adverse Events
ThermalonTrueTear™
Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total2/29 (6.9%) 2/28 (7.1%)
Eye disorders
Vision blurred2/29 (6.9%) 0/28 (0%)
Respiratory, thoracic and mediastinal disorders
Nasal congestion0/29 (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/TitleTherapeutic Area, Head
OrganizationAllergan
Phone714-246-4500
Emailclinicaltrials@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