Back to resultsSafety and Efficacy of TrueTear™ for the Treatment of Meibomian Gland Disease
Primary Purpose
Meibomian Glands, Dry Eye Syndromes
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
TrueTear™
Thermalon Dry Eye Compress
Sponsored by
About this trial
This is an interventional treatment trial for Meibomian Glands
Eligibility Criteria
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.
Sites / Locations
- Andover Eye Associates
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Thermalon
TrueTear™
Arm 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.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03226769
Brief Title
Safety and Efficacy of TrueTear™ for the Treatment of Meibomian Gland Disease
Official Title
Prospective, Open-Label, Randomized, Proof of Concept Study Exploring Application of TrueTear™ for the Treatment of Meibomian Gland Disease
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
July 26, 2017 (Actual)
Primary Completion Date
December 12, 2017 (Actual)
Study Completion Date
December 12, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allergan
4. Oversight
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
Data Monitoring Committee
No
5. 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Meibomian Glands, Dry Eye Syndromes
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
57 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Thermalon
Arm Type
Active Comparator
Arm Description
Participants received application of Thermalon dry eye compress on Days 0 and 7 followed by daily use as per label instructions.
Arm Title
TrueTear™
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
TrueTear™
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Thermalon Dry Eye Compress
Intervention Description
Application of Thermalon Dry Eye Compress at Day 0, Day 7 and daily use as per label instructions.
Primary Outcome Measure Information:
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
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gail Torkildsen
Organizational Affiliation
mdlasik@comcast.net
Official's Role
Principal Investigator
Facility Information:
Facility Name
Andover Eye Associates
City
Andover
State/Province
Massachusetts
ZIP/Postal Code
01810
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Safety and Efficacy of TrueTear™ for the Treatment of Meibomian Gland Disease
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