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

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)

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)

Study Overview

• Status: Completed
• Conditions: Dry Eye; Meibomian Gland Dysfunction
• Intervention / Treatment: Drug: AZR-MD-001 Low Dose; Drug: AZR-MD-001 Mid Dose; Drug: AZR-MD-001 High Dose; Drug: AZR-MD-001 Vehicle

Detailed Description

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)

• Study Type: Interventional
• Enrollment (Actual): 321
• Phase: Phase 2

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Chatswood, New South Wales, Australia, 2067
      • Vision Eye Institute
    • Sydney, New South Wales, Australia, 2000
      • Sydney Eye Hospital
    • Sydney, New South Wales, Australia, 2000
      • Eye Associates
    • Sydney, New South Wales, Australia, 2052
      • School of Optometry and Vision Science, University of New South Wales
  • Queensland
    • Brisbane, Queensland, Australia, 4059
      • Queensland University of Technology
    • South Brisbane, Queensland, Australia, 4101
      • Queensland Eye Institute
    • Teneriffe, Queensland, Australia, 4005
      • Ophthalmic Trials Australia
  • Victoria
    • Armadale, Victoria, Australia, 3143
      • Eye Laser Specialists
    • Bendigo, Victoria, Australia, 3550
      • Bendigo Eye Clinic
    • Glen Waverley, Victoria, Australia, 3150
      • Waverley Eye Clinic
    • Melbourne, Victoria, Australia, 3053
      • Downie Laboratory, Department of Optometry and Vision Sciences
    • Waurn Ponds, Victoria, Australia, 3216
      • Deakin University
• Canada
  • Alberta
    • Calgary, Alberta, Canada, AB T2V 4J2
      • Seema Eye Care
  • British Columbia
    • Campbell River, British Columbia, Canada
      • FYI Doctors
    • Vancouver, British Columbia, Canada, V5Z 3N8
      • VCH Research Institute.
    • Vancouver, British Columbia, Canada, V6H1H2
      • Ophthalmology
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, NS B3J 1J7
      • Ocean Optometry
    • Halifax, Nova Scotia, Canada
      • Miller Optometry
  • Ontario
    • Brampton, Ontario, Canada, 6Y 4M3
      • Prism Eye Institute
    • Mississauga, Ontario, Canada, L4W 1A4
      • Cliantha Research
    • Ottawa, Ontario, Canada, K1H 8L6
      • Ottawa Hospital
    • Ottawa, Ontario, Canada, K1G 3Y7
      • Precision Cornea Centre
    • Toronto, Ontario, Canada, M5T 2S8
      • Toronto Western Hospital
    • Toronto, Ontario, Canada, L3R 1N1
      • FYI Doctors
    • Toronto, Ontario, Canada, L6T 0G1
      • Healthpoint
    • Toronto, Ontario, Canada, M2N3A1
      • Eyes on Sheppard Clinic
    • Toronto, Ontario, Canada, M4W 0A7
      • Toronto Eye Care
    • Waterloo, Ontario, Canada, N2L 3G1
      • School of Optometry & Vision Science, University of Waterloo
• New Zealand
  • Auckland, New Zealand, 1023
    • University of Auckland
  • Auckland, New Zealand, 1050
    • AucklandEye

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AZR-MD-001 Low Dose; AZR-MD-001 Low Dose will be dosed up to once daily.	Drug: AZR-MD-001 Low Dose; AZR-MD-001 is an ophthalmic ointment
Experimental: AZR-MD-001 Mid Dose; AZR-MD-001 Mid Dose will be dosed up to once daily.	Drug: AZR-MD-001 Mid Dose; AZR-MD-001 is an ophthalmic ointment
Experimental: AZR-MD-001 High Dose; AZR-MD-001 High Dose will be dosed up to once daily.	Drug: AZR-MD-001 High Dose; AZR-MD-001 is an ophthalmic ointment
Sham Comparator: AZR-MD-001 Vehicle; AZR-MD-001 Vehicle will be dosed up to once daily.	Drug: AZR-MD-001 Vehicle; AZR-MD-001 is a vehicle ophthalmic ointment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Meibomian Glands Yielding Liquid Secretion (MGYLS)	Change from Baseline in MGYLS. The MGYLS can range from 0 (abnormal) to 15 (normal)	Value at month 3 minus value at baseline
Ocular Surface Disease Index (OSDI) Total Score	Change from Baseline in OSDI Total Score. The OSDI Total Score can range from 100 (highly abnormal) to 0 (Normal)	Value at month 3 minus value at baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Meibum Gland Secretion Score (MGS)	Change from Baseline in MGS. The MGS can range from 0 (highly abnormal) to 45 (Normal)	Day 14, Month 1, Month 1.5
Meibomian Glands Yielding Liquid Secretion (MGYLS)	Change from Baseline in MGYLS. The MGYLS can range from 0 (abnormal) to 15 (normal)	Day 14, Month 1, Month 1.5

Collaborators and Investigators

• Sponsor: Azura Ophthalmics
• Collaborators: Syneos Health; Cliantha Research
• Investigators: Principal Investigator: Stephanie L Watson, Save Sight Institute

Study record dates

Study Major Dates

• Study Start (Actual): September 10, 2018
• Primary Completion (Actual): September 14, 2022
• Study Completion (Actual): October 19, 2022

Study Registration Dates

• First Submitted: August 27, 2018
• First Submitted That Met QC Criteria: August 27, 2018
• First Posted (Actual): August 29, 2018

Study Record Updates

• Last Update Posted (Actual): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 14, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Eyelid Diseases; Eye Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca; Meibomian Gland Dysfunction
• Other Study ID Numbers: AZ201801

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No