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Safety and Efficacy of TrueTear™ for the Treatment of Meibomian Gland Disease

NCT03226769 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 57

Last updated 2020-10-30

Study results available
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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).

Conditions

  • Meibomian Glands
  • Dry Eye Syndromes

Interventions

DEVICE

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.

DEVICE

Thermalon Dry Eye Compress

Application of Thermalon Dry Eye Compress at Day 0, Day 7 and daily use as per label instructions.

Sponsors & Collaborators

  • Allergan

    lead INDUSTRY

Principal Investigators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-26
Primary Completion
2017-12-12
Completion
2017-12-12
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03226769 on ClinicalTrials.gov