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Completed

NCT Number: NCT04314362

Methods to Enhance AZR-MD-001 for Meibomian Gland Dysfunction (MGD)

Single-center, single-masked (the individual(s) performing efficacy and safety measures will be masked to treatment assignment for the patient(s) they are assessing), vehicle-controlled, randomized study.

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Key information

Conditions

Meibomian Gland Dysfunction Eye Diseases Eyelid Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Fiona Stapleton

Sydney, New South Wales, Australia

About this study

Randomized study with 6 visits. For all dose groups a screening visit will be followed by a baseline visit 14 days later (qualification period). At the end of the qualification period patients who still exhibit signs of Meibomian Gland Dysfunction (MGD) at the baseline visit will be enrolled into a 3-month treatment period. At the baseline (Day 0) visit, patients will be randomly assigned to receive either AZR-MD-001 ointment/semi-solid drug or AZR-MD-001 vehicle twice-weekly.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Evidence of meibomian gland obstruction (based on a meibomian gland secretion (MGS) score of ≤12 for 15 glands of the lower lid) in both eyes at the baseline visit
  • Reported dry eye signs and symptoms within the past 3 months:

Ocular Surface Disease Index (OSDI) score ≥ 13; TBUT < 10 seconds in both eyes

Exclusion criteria

  • Uncontrolled ocular disease (except for MGD) or uncontrolled systemic disease
  • Patient has glaucoma or ocular hypertension as demonstrated by an intraocular pressure (IOP) in either eye at screening of ≥24 mm Hg determined by Goldman applanation tonometry 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 (keratoconus, pterygia, scarring) or corneal integrity
  • Recent (within the past 3 months of the baseline visit) ocular surgery, trauma, herpes, or recurrent inflammation
  • Contact lens use anticipated during the study

Treatment and study plan

AZR-MD-001 ointment/semi-solid drug

Drug

AZR-MD-001 (1.0%) and suitable excipient

Primary outcomes

  1. Primary Efficacy for MGD: Change From Baseline to Month 3 in Meibomian Gland Secretion Score (MGS)

    Time frame: Month 3

    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 were evaluated along the lower eyelid margin, consisting of 5 glands located in each of the temporal, central and nasal regions. For each of the 15 glands, expressed secretion characteristics were graded on a 0-3 scale using the published methods from Lane and Colleagues (2012)

    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.

Sponsors and collaborators

Lead sponsor

Azura Ophthalmics

Industry

Collaborators

  • The University of New South Wales

Registry information

Official study title

A Single-center, Vehicle-controlled, Study to Evaluate Methods to Enhance AZR-MD-001 for Meibomian Gland Dysfunction (MGD)

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Mar 19, 2020
Registry last updated
Jan 25, 2023

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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