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

Primary Purpose

Meibomian Gland Dysfunction

Status
Completed
Phase
Phase 2
Locations
Australia
Study Type
Interventional
Intervention
AZR-MD-001 ointment/semi-solid drug
Sponsored by
Azura Ophthalmics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Meibomian Gland Dysfunction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Fiona Stapleton

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

AZR-MD-001 Active

AZR-MD-001 Active + Conventional Treatment

AZR-MD-001 vehicle

Arm Description

AZR-MD-001 ointment/semi-solid drug (1.0%)

AZR-MD-001 ointment/semi-solid drug (1.0%) plus Hylo-Forte®

AZR-MD-001 vehicle control

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
March 17, 2020
Last Updated
April 25, 2022
Sponsor
Azura Ophthalmics
Collaborators
The University of New South Wales
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1. Study Identification

Unique Protocol Identification Number
NCT04314362
Brief Title
Methods to Enhance AZR-MD-001 for Meibomian Gland Dysfunction (MGD)
Official Title
A Single-center, Vehicle-controlled, Study to Evaluate Methods to Enhance AZR-MD-001 for Meibomian Gland Dysfunction (MGD)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
July 14, 2020 (Actual)
Primary Completion Date
January 6, 2021 (Actual)
Study Completion Date
January 6, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Azura Ophthalmics
Collaborators
The University of New South Wales

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Meibomian Gland Dysfunction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AZR-MD-001 Active
Arm Type
Experimental
Arm Description
AZR-MD-001 ointment/semi-solid drug (1.0%)
Arm Title
AZR-MD-001 Active + Conventional Treatment
Arm Type
Experimental
Arm Description
AZR-MD-001 ointment/semi-solid drug (1.0%) plus Hylo-Forte®
Arm Title
AZR-MD-001 vehicle
Arm Type
Experimental
Arm Description
AZR-MD-001 vehicle control
Intervention Type
Drug
Intervention Name(s)
AZR-MD-001 ointment/semi-solid drug
Intervention Description
AZR-MD-001 (1.0%) and suitable excipient
Primary Outcome Measure Information:
Title
Primary Efficacy for MGD: Change From Baseline to Month 3 in Meibomian Gland Secretion Score (MGS)
Description
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.
Time Frame
Month 3

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Fiona Stapleton
City
Sydney
State/Province
New South Wales
Country
Australia

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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