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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Thermalon | Active Comparator | Participants received application of Thermalon dry eye compress on Days 0 and 7 followed by daily use as per label instructions. |
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| TrueTear™ | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TrueTear™ | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline (Day 0) to Day 30 |
| 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. | Baseline (Day 0) to Day 30 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gail Torkildsen | mdlasik@comcast.net | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Andover Eye Associates | Andover | Massachusetts | 01810 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Thermalon | Participants received application of Thermalon dry eye compress on Days 0 and 7 followed by daily use as per label instructions. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Intent-to-treat (ITT) population included all randomized participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Thermalon | Participants received application of Thermalon dry eye compress on Days 0 and 7 followed by daily use as per label instructions. |
| BG001 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | ITT population included all randomized participants. Overall number of participants analyzed is the number of participants with data available for analyses. | Posted | Mean | Standard Deviation | score on scale | Baseline (Day 0) to Day 30 |
Up to Day 30
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Thermalon | Participants received application of Thermalon dry eye compress on Days 0 and 7 followed by daily use as per label instructions. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vision blurred | Eye disorders | MedDRA: 20.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area, Head | Allergan | 714-246-4500 | clinicaltrials@allergan.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 25, 2018 | Oct 8, 2020 | SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Jun 1, 2017 | Oct 8, 2020 | Prot_001.pdf |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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| Thermalon Dry Eye Compress | Device | Application of Thermalon Dry Eye Compress at Day 0, Day 7 and daily use as per label instructions. |
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| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Meibomian Gland Dysfunction (MGD) Impact Questionnaire Score | MGD impact questionnaire includes 10 questions about impacts participant may experience associated with MGD. Question/s (Qs) 1-6 were rated on a scale of 1=no difficulty to 5=lot of difficulty. Q7 was rated on scale of 1=never to 5=all the time. If participants did not experience particular impact, they chose 0=Not applicable (NA) for Qs 1-7. Q8 was rated on scale 0-4, where 0=no time at all to 4=lot of time, Qs 9-10 were rated on scale 0-4, with 0=not at all bothered to 4=very bothered. Higher scores represented greater impact. For additional scale information see Outcome Measure section. | Mean | Full Range | score on a scale |
|
| 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. For additional scale information see Outcome Measure section. | Mean | Full Range | score on a scale |
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| ID | Title | Description |
|---|---|---|
| OG000 | Thermalon | Participants received application of Thermalon dry eye compress on Days 0 and 7 followed by daily use as per label instructions. |
| OG001 | 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. |
|
|
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| 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. | ITT population included all randomized participants. Overall number of participants analyzed is the number of participants with data available for analyses. | Posted | Mean | Standard Deviation | score on a scale | Baseline (Day 0) to Day 30 |
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| 0 |
| 29 |
| 0 |
| 29 |
| 2 |
| 29 |
| EG001 | 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. | 0 | 28 | 0 | 28 | 2 | 28 |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA: 20.1 | Systematic Assessment |
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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.
| Dry Eyes |
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| Itchy Eyes |
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| Burning Eyes |
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| Gritty Eyes |
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| Painful Eyes |
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| Watery Eyes |
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| Swollen Eyelids |
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| Red Eyelids |
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| Crusty Eyelids |
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Blurred Vision |
| Wilcoxon rank-sum test |
| 0.9786 |
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. |
| Other |
The null hypothesis is that there is no difference between the two devices, TrueTear™ and Thermalon. |
| Dry Eyes | Wilcoxon rank-sum test | 0.3894 | 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. | Other | The null hypothesis is that there is no difference between the two devices, TrueTear™ and Thermalon. |
| Itchy Eyes | Wilcoxon rank-sum test | 0.0591 | 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. | Other | The null hypothesis is that there is no difference between the two devices, TrueTear™ and Thermalon. |
| Burning Eyes | Wilcoxon rank-sum test | 0.1818 | 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. | Other | The null hypothesis is that there is no difference between the two devices, TrueTear™ and Thermalon. |
| Gritty Eyes | Wilcoxon rank-sum test | 0.4284 | 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. | Other | The null hypothesis is that there is no difference between the two devices, TrueTear™ and Thermalon. |
| Painful Eyes | Wilcoxon rank-sum test | 0.1051 | 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. | Other | The null hypothesis is that there is no difference between the two devices, TrueTear™ and Thermalon. |
| Watery Eyes | Wilcoxon rank-sum test | 0.7998 | 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. | Other | The null hypothesis is that there is no difference between the two devices, TrueTear™ and Thermalon. |
| Swollen Eyelids | Wilcoxon rank-sum test | 0.1229 | 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. | Other | The null hypothesis is that there is no difference between the two devices, TrueTear™ and Thermalon. |
| Red Eyelids | Wilcoxon rank-sum test | 0.3907 | 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. | Other | The null hypothesis is that there is no difference between the two devices, TrueTear™ and Thermalon. |
| Crusty Eyelids | Wilcoxon rank-sum test | 0.0336 | 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. | Other | The null hypothesis is that there is no difference between the two devices, TrueTear™ and Thermalon. |