Evaluation of AZR-MD-001 in Patients With Meibomian Gland Dysfunction (MGD)

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

AZ202001 is a multicenter study of AZR-MD-001 ointment and AZR-MD-001 vehicle in patients with Meibomian Gland Dysfunction (MGD)

Study Overview

• Status: Completed
• Conditions: Meibomian Gland Dysfunction
• Intervention / Treatment: Drug: AZR-MD-001 Vehicle; Drug: AZR-MD-001 Active

Detailed Description

AZ202001 is a multicenter, double-masked, vehicle-controlled, randomized, parallel group study evaluating the safety, efficacy and tolerability of AZR-MD-001 ointment and AZR-MD-001 vehicle in patients with Meibomian Gland Dysfunction (MGD)

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Phase 2

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Sydney, New South Wales, Australia
      • Fiona Stapleton
  • Queensland
    • Brisbane, Queensland, Australia
      • Scott A Read
    • Maroochydore, Queensland, Australia
      • Susan Thackwray
• New Zealand
  • Auckland, New Zealand
    • Jagrut Lallu
  • Auckland, New Zealand
    • Jennifer P Craig

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AZR-MD-001 Vehicle; AZR-MD-001 Vehicle will be dosed up to twice weekly.	Drug: AZR-MD-001 Vehicle; AZR-MD-001 is a vehicle ophthalmic ointment; Other Names: AZR-MD-001 Vehicle is an ophthalmic ointment
Experimental: AZR-MD-001 Active; AZR-MD-001 Active will be dosed up to twice weekly.	Drug: AZR-MD-001 Active; AZR-MD-001 is an active ophthalmic ointment; Other Names: AZR-MD-001 is an ophthalmic ointment

What is the study measuring?

Primary 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). Meibomian gland assessment was completed using a handheld instrument, Meibomian Gland Evaluator, along the eyelid margin to ensure measurement consistency. A total of 15 glands will be evaluated along the lower eyelid margin, consisting of 5 glands located in each of the temporal, central and nasal regions, as shown below. For each of the 15 glands, expressed secretion characteristics will be graded on a 0-3 scale. For more detail see: Lane SS, DuBiner HB, Epstein RJ, et al. A new system, the LipiFlow, for the treatment of meibomian gland dysfunction (MGD). Cornea. 2012; 31(4): 396-404.	Month 3

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total OSDI	Change from Baseline in Total Ocular Surface Disease Index (OSDI). The Total OSDI can range from 0 (normal) to 100 (abnormal). The OSDI questionnaire consists of 12 questions regarding ocular symptoms, environmental triggers, and vision-related functioning. The patient was asked to rate each symptom using a 5-point scale (0 to 4), where 0 = none of the time; 1 = some of the time; 2 = half of the time; 3 = most of the time; and 4 = all of the time. Seven questions related to visual functioning allow a response of "N/A" (not applicable). The total OSDI was calculated from the raw scores of each of the 12 questions based on the formula: ([sum of scores for all questions answereda] X 100)/([total number of questions answered] X 4). Questions answered with N/A were excluded in the calculation of total OSDI.	Day 14 to Month 3

Collaborators and Investigators

• Sponsor: Azura Ophthalmics
• Collaborators: Avania
• Investigators: Principal Investigator: Jacqueline Tan-Showyin, School of Optometry and Vision Science, University of New South Wales

Study record dates

Study Major Dates

• Study Start (Actual): July 17, 2020
• Primary Completion (Actual): January 6, 2021
• Study Completion (Actual): January 6, 2021

Study Registration Dates

• First Submitted: May 13, 2020
• First Submitted That Met QC Criteria: May 15, 2020
• First Posted (Actual): May 18, 2020

Study Record Updates

• Last Update Posted (Actual): May 16, 2022
• Last Update Submitted That Met QC Criteria: March 1, 2022
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Eyelid Diseases; Meibomian Gland Dysfunction
• Other Study ID Numbers: AZ202001

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