Dry Eye Syndromes, Meibomian Glands
Conditions
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).
Interventions
DEVICETrueTear™
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.
DEVICEThermalon Dry Eye Compress
Application of Thermalon Dry Eye Compress at Day 0, Day 7 and daily use as per label instructions.
Sponsors
Allergan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Thermalon Participants received application of Thermalon dry eye compress on Days 0 and 7 followed by daily use as per label instructions. | 29 |
| 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. | 28 |
| Total | 57 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Thermalon | TrueTear™ | Total |
|---|---|---|---|
| Age, Continuous | 63.2 years STANDARD_DEVIATION 12.16 | 63.8 years STANDARD_DEVIATION 13.91 | 63.5 years STANDARD_DEVIATION 12.94 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 2 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 29 Participants | 26 Participants | 55 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Meibomian Gland Dysfunction (MGD) Impact Questionnaire Score Bothered by Appearance | 1.1 score on a scale | 1.2 score on a scale | 1.1 score on a scale |
| Meibomian Gland Dysfunction (MGD) Impact Questionnaire Score Bothered With Amount of Time Taking Care of Eyes | 1.3 score on a scale | 0.9 score on a scale | 1.1 score on a scale |
| Meibomian Gland Dysfunction (MGD) Impact Questionnaire Score Computer Usage | 2.3 score on a scale | 2.0 score on a scale | 2.1 score on a scale |
| Meibomian Gland Dysfunction (MGD) Impact Questionnaire Score Driving | 2.0 score on a scale | 2.1 score on a scale | 2.0 score on a scale |
| Meibomian Gland Dysfunction (MGD) Impact Questionnaire Score Frequency of Outdoor Activities | 2.0 score on a scale | 1.8 score on a scale | 1.9 score on a scale |
| Meibomian Gland Dysfunction (MGD) Impact Questionnaire Score Leisure Activities | 2.5 score on a scale | 2.2 score on a scale | 2.3 score on a scale |
| Meibomian Gland Dysfunction (MGD) Impact Questionnaire Score Outdoor Activities | 1.9 score on a scale | 1.6 score on a scale | 1.7 score on a scale |
| Meibomian Gland Dysfunction (MGD) Impact Questionnaire Score Reading | 2.7 score on a scale | 2.0 score on a scale | 2.3 score on a scale |
| Meibomian Gland Dysfunction (MGD) Impact Questionnaire Score Social Activities | 1.4 score on a scale | 1.7 score on a scale | 1.5 score on a scale |
| Meibomian Gland Dysfunction (MGD) Impact Questionnaire Score Time Spent to Take Care of Eyes | 1.7 score on a scale | 1.4 score on a scale | 1.5 score on a scale |
| MGD Symptoms Questionnaire Score Blurred Vision | 1.4 score on a scale | 1.2 score on a scale | 1.3 score on a scale |
| MGD Symptoms Questionnaire Score Burning Eyes | 1.5 score on a scale | 1.5 score on a scale | 1.5 score on a scale |
| MGD Symptoms Questionnaire Score Crusty Eyelids | 1.0 score on a scale | 1.1 score on a scale | 1.0 score on a scale |
| MGD Symptoms Questionnaire Score Dry Eyes | 2.6 score on a scale | 2.5 score on a scale | 2.5 score on a scale |
| MGD Symptoms Questionnaire Score Gritty Eyes | 2.0 score on a scale | 1.7 score on a scale | 1.8 score on a scale |
| MGD Symptoms Questionnaire Score Itchy Eyes | 2.2 score on a scale | 1.6 score on a scale | 1.9 score on a scale |
| MGD Symptoms Questionnaire Score Painful Eyes | 1.0 score on a scale | 0.9 score on a scale | 0.9 score on a scale |
| MGD Symptoms Questionnaire Score Red Eyelids | 0.9 score on a scale | 1.0 score on a scale | 0.9 score on a scale |
| MGD Symptoms Questionnaire Score Red Eyes | 1.3 score on a scale | 1.2 score on a scale | 1.2 score on a scale |
| MGD Symptoms Questionnaire Score Swollen Eyelids | 0.6 score on a scale | 0.5 score on a scale | 0.5 score on a scale |
| MGD Symptoms Questionnaire Score Watery Eyes | 1.3 score on a scale | 1.3 score on a scale | 1.3 score on a scale |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 27 Participants | 28 Participants | 55 Participants |
| Sex: Female, Male Female | 18 Participants | 19 Participants | 37 Participants |
| Sex: Female, Male Male | 11 Participants | 9 Participants | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 29 | 0 / 28 |
| other Total, other adverse events | 2 / 29 | 2 / 28 |
| serious Total, serious adverse events | 0 / 29 | 0 / 28 |
Outcome results
Primary
Change From Baseline in Meibomian Gland Dysfunction (MGD) Impact Questionnaire Score
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
Population: ITT population included all randomized participants. Overall number of participants analyzed is the number of participants with data available for analyses.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Thermalon | Change From Baseline in Meibomian Gland Dysfunction (MGD) Impact Questionnaire Score | Computer Usage | -0.4 score on scale | Standard Deviation 0.86 |
| Thermalon | Change From Baseline in Meibomian Gland Dysfunction (MGD) Impact Questionnaire Score | Reading | -0.4 score on scale | Standard Deviation 0.9 |
| Thermalon | Change From Baseline in Meibomian Gland Dysfunction (MGD) Impact Questionnaire Score | Leisure Activities | -0.3 score on scale | Standard Deviation 0.89 |
| Thermalon | Change From Baseline in Meibomian Gland Dysfunction (MGD) Impact Questionnaire Score | Social Activities | -0.2 score on scale | Standard Deviation 0.87 |
| Thermalon | Change From Baseline in Meibomian Gland Dysfunction (MGD) Impact Questionnaire Score | Driving | -0.1 score on scale | Standard Deviation 0.92 |
| Thermalon | Change From Baseline in Meibomian Gland Dysfunction (MGD) Impact Questionnaire Score | Outdoor Activities | -0.3 score on scale | Standard Deviation 0.81 |
| Thermalon | Change From Baseline in Meibomian Gland Dysfunction (MGD) Impact Questionnaire Score | Frequency of Outdoor Activities | -0.2 score on scale | Standard Deviation 0.69 |
| Thermalon | 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 |
| Thermalon | 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 |
| Thermalon | Change From Baseline in Meibomian Gland Dysfunction (MGD) Impact Questionnaire Score | Bothered by Appearance | -0.3 score on scale | Standard Deviation 0.77 |
| TrueTear™ | 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 0.91 |
| TrueTear™ | Change From Baseline in Meibomian Gland Dysfunction (MGD) Impact Questionnaire Score | Computer Usage | -0.3 score on scale | Standard Deviation 0.83 |
| TrueTear™ | Change From Baseline in Meibomian Gland Dysfunction (MGD) Impact Questionnaire Score | Outdoor Activities | -0.1 score on scale | Standard Deviation 0.85 |
| TrueTear™ | Change From Baseline in Meibomian Gland Dysfunction (MGD) Impact Questionnaire Score | Reading | -0.2 score on scale | Standard Deviation 0.79 |
| TrueTear™ | Change From Baseline in Meibomian Gland Dysfunction (MGD) Impact Questionnaire Score | Bothered by Appearance | -0.1 score on scale | Standard Deviation 0.82 |
| TrueTear™ | Change From Baseline in Meibomian Gland Dysfunction (MGD) Impact Questionnaire Score | Leisure Activities | -0.4 score on scale | Standard Deviation 0.89 |
| TrueTear™ | Change From Baseline in Meibomian Gland Dysfunction (MGD) Impact Questionnaire Score | Frequency of Outdoor Activities | -0.1 score on scale | Standard Deviation 0.83 |
| TrueTear™ | Change From Baseline in Meibomian Gland Dysfunction (MGD) Impact Questionnaire Score | Social Activities | -0.2 score on scale | Standard Deviation 0.79 |
| TrueTear™ | Change From Baseline in Meibomian Gland Dysfunction (MGD) Impact Questionnaire Score | Bothered With Amount of Time Taking Care of Eyes | 0.0 score on scale | Standard Deviation 1.09 |
| TrueTear™ | Change From Baseline in Meibomian Gland Dysfunction (MGD) Impact Questionnaire Score | Driving | -0.2 score on scale | Standard Deviation 1.05 |
Comparison: Computer Usagep-value: 0.9788Wilcoxon rank-sum test
Comparison: Readingp-value: 0.6571Wilcoxon rank-sum test
Comparison: Leisure Activitiesp-value: 0.471Wilcoxon rank-sum test
Comparison: Social Activitiesp-value: 0.736Wilcoxon rank-sum test
Comparison: Drivingp-value: 0.4999Wilcoxon rank-sum test
Comparison: Outdoor Activitiesp-value: 0.1159Wilcoxon rank-sum test
Comparison: Frequency of Outdoor Activitiesp-value: 0.4567Wilcoxon rank-sum test
Comparison: Time Spent to Take Care of Eyesp-value: 0.3439Wilcoxon rank-sum test
Comparison: Bothered With Amount of Time Taking Care of Eyesp-value: 0.3331Wilcoxon rank-sum test
Comparison: Bothered by Appearancep-value: 0.4774Wilcoxon rank-sum test
Primary
Change From Baseline in MGD Symptoms Questionnaire Score
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
Population: ITT population included all randomized participants. Overall number of participants analyzed is the number of participants with data available for analyses.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Thermalon | Change From Baseline in MGD Symptoms Questionnaire Score | Itchy Eyes | -0.8 score on a scale | Standard Deviation 1.23 |
| Thermalon | Change From Baseline in MGD Symptoms Questionnaire Score | Painful Eyes | -0.4 score on a scale | Standard Deviation 0.87 |
| Thermalon | Change From Baseline in MGD Symptoms Questionnaire Score | Dry Eyes | -0.3 score on a scale | Standard Deviation 1.04 |
| Thermalon | Change From Baseline in MGD Symptoms Questionnaire Score | Watery Eyes | 0.0 score on a scale | Standard Deviation 1.2 |
| Thermalon | Change From Baseline in MGD Symptoms Questionnaire Score | Burning Eyes | -0.2 score on a scale | Standard Deviation 0.77 |
| Thermalon | Change From Baseline in MGD Symptoms Questionnaire Score | Swollen Eyelids | 0.0 score on a scale | Standard Deviation 0.93 |
| Thermalon | Change From Baseline in MGD Symptoms Questionnaire Score | Blurred Vision | -0.2 score on a scale | Standard Deviation 0.85 |
| Thermalon | Change From Baseline in MGD Symptoms Questionnaire Score | Red Eyelids | 0.0 score on a scale | Standard Deviation 0.78 |
| Thermalon | Change From Baseline in MGD Symptoms Questionnaire Score | Gritty Eyes | -0.2 score on a scale | Standard Deviation 0.99 |
| Thermalon | Change From Baseline in MGD Symptoms Questionnaire Score | Crusty Eyelids | 0.1 score on a scale | Standard Deviation 0.75 |
| Thermalon | Change From Baseline in MGD Symptoms Questionnaire Score | Red Eyes | -0.2 score on a scale | Standard Deviation 0.76 |
| TrueTear™ | Change From Baseline in MGD Symptoms Questionnaire Score | Crusty Eyelids | -0.4 score on a scale | Standard Deviation 0.74 |
| TrueTear™ | Change From Baseline in MGD Symptoms Questionnaire Score | Red Eyes | -0.1 score on a scale | Standard Deviation 0.83 |
| TrueTear™ | Change From Baseline in MGD Symptoms Questionnaire Score | Blurred Vision | -0.2 score on a scale | Standard Deviation 0.8 |
| TrueTear™ | Change From Baseline in MGD Symptoms Questionnaire Score | Dry Eyes | -0.5 score on a scale | Standard Deviation 0.85 |
| TrueTear™ | Change From Baseline in MGD Symptoms Questionnaire Score | Itchy Eyes | -0.3 score on a scale | Standard Deviation 0.99 |
| TrueTear™ | Change From Baseline in MGD Symptoms Questionnaire Score | Burning Eyes | -0.5 score on a scale | Standard Deviation 0.89 |
| TrueTear™ | Change From Baseline in MGD Symptoms Questionnaire Score | Gritty Eyes | -0.4 score on a scale | Standard Deviation 0.88 |
| TrueTear™ | Change From Baseline in MGD Symptoms Questionnaire Score | Painful Eyes | -0.1 score on a scale | Standard Deviation 0.62 |
| TrueTear™ | Change From Baseline in MGD Symptoms Questionnaire Score | Watery Eyes | -0.1 score on a scale | Standard Deviation 0.75 |
| TrueTear™ | Change From Baseline in MGD Symptoms Questionnaire Score | Swollen Eyelids | 0.3 score on a scale | Standard Deviation 0.66 |
| TrueTear™ | Change From Baseline in MGD Symptoms Questionnaire Score | Red Eyelids | -0.1 score on a scale | Standard Deviation 0.46 |
Comparison: Red Eyesp-value: 0.5457Wilcoxon rank-sum test
Comparison: Blurred Visionp-value: 0.9786Wilcoxon rank-sum test
Comparison: Dry Eyesp-value: 0.3894Wilcoxon rank-sum test
Comparison: Itchy Eyesp-value: 0.0591Wilcoxon rank-sum test
Comparison: Burning Eyesp-value: 0.1818Wilcoxon rank-sum test
Comparison: Gritty Eyesp-value: 0.4284Wilcoxon rank-sum test
Comparison: Painful Eyesp-value: 0.1051Wilcoxon rank-sum test
Comparison: Watery Eyesp-value: 0.7998Wilcoxon rank-sum test
Comparison: Swollen Eyelidsp-value: 0.1229Wilcoxon rank-sum test
Comparison: Red Eyelidsp-value: 0.3907Wilcoxon rank-sum test
Comparison: Crusty Eyelidsp-value: 0.0336Wilcoxon rank-sum test