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

Prospective, Open-Label, Randomized, Proof of Concept Study Exploring Application of TrueTear™ for the Treatment of Meibomian Gland Disease

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).

Study Overview

• Status: Completed
• Conditions: Dry Eye Syndromes; Meibomian Glands
• Intervention / Treatment: Device: Thermalon Dry Eye Compress; Device: TrueTear™

• Study Type: Interventional
• Enrollment (Actual): 57
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Andover, Massachusetts, United States, 01810
      • Andover Eye Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Thermalon; Participants received application of Thermalon dry eye compress on Days 0 and 7 followed by daily use as per label instructions.	Device: Thermalon Dry Eye Compress; Application of Thermalon Dry Eye Compress at Day 0, Day 7 and daily use as per label instructions.
EXPERIMENTAL: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Allergan
• Investigators: Principal Investigator: Gail Torkildsen, mdlasik@comcast.net

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 26, 2017
• Primary Completion (ACTUAL): December 12, 2017
• Study Completion (ACTUAL): December 12, 2017

Study Registration Dates

• First Submitted: July 20, 2017
• First Submitted That Met QC Criteria: July 20, 2017
• First Posted (ACTUAL): July 24, 2017

Study Record Updates

• Last Update Posted (ACTUAL): October 30, 2020
• Last Update Submitted That Met QC Criteria: October 8, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Eyelid Diseases; Dry Eye Syndromes; Meibomian Gland Dysfunction
• Other Study ID Numbers: OCUN-023

Drug and device information, study documents

• 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