Safety and Efficacy of TrueTear™ for the Treatment of Meibomian Gland Disease
NCT ID: NCT03226769
Last Updated: 2020-10-30
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
NA
57 participants
INTERVENTIONAL
2017-07-26
2017-12-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Thermalon
Participants received application of Thermalon dry eye compress on Days 0 and 7 followed by daily use as per label instructions.
Thermalon Dry Eye Compress
Application of Thermalon Dry Eye Compress at Day 0, Day 7 and daily use as per label instructions.
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.
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.
Interventions
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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.
Thermalon Dry Eye Compress
Application of Thermalon Dry Eye Compress at Day 0, Day 7 and daily use as per label instructions.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
22 Years
ALL
No
Sponsors
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Allergan
INDUSTRY
Responsible Party
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Principal Investigators
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Locations
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Andover Eye Associates
Andover, Massachusetts, United States
Countries
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Provided Documents
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Document Type: Statistical Analysis Plan
Document Type: Study Protocol
Other Identifiers
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OCUN-023
Identifier Type: -
Identifier Source: org_study_id