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NCT Number: NCT03652051

A Multicenter Study Evaluating AZR-MD-001 in Patients With Meibomian Gland Dysfunction and Evaporative Dry Eye Disease (DED)

AZ201801 is a multicenter study of AZR-MD-001 ointment and AZR-MD-001 vehicle in patients with Meibomian Gland Dysfunction (MGD) and evaporative Dry Eye Disease (DED)

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Key information

Conditions

Meibomian Gland Dysfunction Dry Eye Dry Eye Syndromes Eye Diseases Eyelid Diseases Lacrimal Apparatus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Vision Eye Institute, Chatswood, New South Wales, Australia

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About this study

AZ201801 is a multicenter, double-masked, vehicle-controlled, randomized, parallel group study carried out in 2 sequentially overlapping cohorts evaluating the safety, efficacy and tolerability of AZR-MD-001 ointment and AZR-MD-001 vehicle in patients with Meibomian Gland Dysfunction (MGD) and evaporative Dry Eye Disease (DED)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female, 18 years of age or older
  • Best-corrected visual acuity (BCVA) of 20/40 or better (Snellen equivalent), using the logarithm of the minimum angle of resolution (LogMAR) in each eye
  • Evidence of meibomian gland obstruction
  • Reported dry eye signs and symptoms within the past 3 months

Exclusion criteria

  • Uncontrolled ocular disease (except for MGD and dry eye disease/keratoconjunctivitis sicca) or uncontrolled systemic disease
  • Glaucoma, ocular hypertension, or intraocular pressure (IOP) in either eye at screening ≥24 mm Hg or has planned insertion/removal of glaucoma filtration shunts/devices during the study
  • Corneal abnormality or disorder that impacts normal spreading of the tear film or corneal integrity
  • BCVA worse than 20/40 in either eye
  • Current use of punctal plugs, anticipated insertion during the study, or a history of punctal cautery in either eye

Treatment and study plan

AZR-MD-001 Low Dose

Drug

AZR-MD-001 is an ophthalmic ointment

AZR-MD-001 Mid Dose

Drug

AZR-MD-001 is an ophthalmic ointment

AZR-MD-001 High Dose

Drug

AZR-MD-001 is an ophthalmic ointment

AZR-MD-001 Vehicle

Drug

AZR-MD-001 is a vehicle ophthalmic ointment

Primary outcomes

  1. Meibomian Glands Yielding Liquid Secretion (MGYLS)

    Time frame: Value at month 3 minus value at baseline

    Change from Baseline in MGYLS. The MGYLS can range from 0 (abnormal) to 15 (normal)

  2. Ocular Surface Disease Index (OSDI) Total Score

    Time frame: Value at month 3 minus value at baseline

    Change from Baseline in OSDI Total Score. The OSDI Total Score can range from 100 (highly abnormal) to 0 (Normal)

Sponsors and collaborators

Lead sponsor

Azura Ophthalmics

Industry

Collaborators

  • Cliantha Research
  • Syneos Health

Registry information

Official study title

A Multicenter, Vehicle-controlled, Randomized Study to Evaluate the Safety, Tolerability, Systemic Pharmacokinetics, and Pharmacodynamics of AZR-MD-001 in Patients With Meibomian Gland Dysfunction (MGD) and Evaporative Dry Eye Disease (DED)

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Aug 29, 2018
Registry last updated
Feb 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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