N/A
N=57
Safety and Efficacy of TrueTear™ for the Treatment of Meibomian Gland Disease
Meibomian Glands · Dry Eye Syndromes
Bottom Line
View on ClinicalTrials.gov: NCT03226769 ↗Enrolled (actual)
57
Serious AEs
0.0%
Results posted
Oct 2020
Primary outcome: Primary: Change From Baseline in Meibomian Gland Dysfunction (MGD) Impact Questionnaire Score — -0.4; -0.3; -0.4; -0.2 score on scale — p=0.9788
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- TrueTear™ (Device); Thermalon Dry Eye Compress (Device)
- Age
- Adult, Older Adult · 22+ yrs
- Sex
- All
- Sponsor
- Allergan
- Primary completion
- Dec 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Meibomian Gland Dysfunction (MGD) Impact Questionnaire Score |
-0.4; -0.3; -0.4; -0.2; -0.3; -0.4 | 0.9788 |
| PRIMARY Change From Baseline in MGD Symptoms Questionnaire Score |
-0.2; -0.1; -0.2; -0.2; -0.3; -0.5 | 0.5457 |
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).
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.
Data sourced from ClinicalTrials.gov (NCT03226769). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.