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

Allergan

Status: Completed

Conditions: Dry Eye Syndromes; Meibomian Glands

Treatments: Device: Thermalon Dry Eye Compress; Device: TrueTear™

Study type: Interventional

Funder types: Industry

Identifiers

NCT03226769

OCUN-023

Details and patient eligibility

About

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).

Enrollment: 57 patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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57 participants in 2 patient groups

Thermalon

Active Comparator group

Description:

Participants received application of Thermalon dry eye compress on Days 0 and 7 followed by daily use as per label instructions.

Treatment:

Device: Thermalon Dry Eye Compress

TrueTear™

Experimental group

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.

Treatment:

Device: TrueTear™