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

Primary Purpose

Meibomian Gland Dysfunction, Dry Eye

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
AZR-MD-001 Low Dose
AZR-MD-001 Mid Dose
AZR-MD-001 High Dose
AZR-MD-001 Vehicle
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:

  • 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

Sites / Locations

  • Vision Eye Institute
  • Eye Associates
  • Sydney Eye Hospital
  • School of Optometry and Vision Science, University of New South Wales
  • Queensland University of Technology
  • Queensland Eye Institute
  • Ophthalmic Trials Australia
  • Eye Laser Specialists
  • Bendigo Eye Clinic
  • Waverley Eye Clinic
  • Downie Laboratory, Department of Optometry and Vision Sciences
  • Deakin University
  • Seema Eye Care
  • FYI Doctors
  • VCH Research Institute.
  • Ophthalmology
  • Ocean Optometry
  • Miller Optometry
  • Prism Eye Institute
  • Cliantha Research
  • Precision Cornea Centre
  • Ottawa Hospital
  • FYI Doctors
  • Healthpoint
  • Eyes on Sheppard Clinic
  • Toronto Eye Care
  • Toronto Western Hospital
  • School of Optometry & Vision Science, University of Waterloo
  • University of Auckland
  • AucklandEye

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Sham Comparator

Arm Label

AZR-MD-001 Low Dose

AZR-MD-001 Mid Dose

AZR-MD-001 High Dose

AZR-MD-001 Vehicle

Arm Description

AZR-MD-001 Low Dose will be dosed up to once daily.

AZR-MD-001 Mid Dose will be dosed up to once daily.

AZR-MD-001 High Dose will be dosed up to once daily.

AZR-MD-001 Vehicle will be dosed up to once daily.

Outcomes

Primary Outcome Measures

Meibum Gland Secretion Score (MGS)
Change from Baseline in MGS. The MGS can range from 0 (highly abnormal) to 45 (Normal)
Meibomian Glands Yielding Liquid Secretion (MGYLS)
Change from Baseline in MGYLS. The MGYLS can range from 0 (abnormal) to 15 (normal)

Secondary Outcome Measures

Meibum Gland Secretion Score (MGS)
Change from Baseline in MGS. The MGS can range from 0 (highly abnormal) to 45 (Normal)
Meibomian Glands Yielding Liquid Secretion (MGYLS)
Change from Baseline in MGYLS. The MGYLS can range from 0 (abnormal) to 15 (normal)

Full Information

First Posted
August 27, 2018
Last Updated
November 23, 2022
Sponsor
Azura Ophthalmics
Collaborators
Syneos Health, Cliantha Research
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1. Study Identification

Unique Protocol Identification Number
NCT03652051
Brief Title
A Multicenter Study Evaluating AZR-MD-001 in Patients With Meibomian Gland Dysfunction and Evaporative Dry Eye Disease (DED)
Official 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)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
September 10, 2018 (Actual)
Primary Completion Date
September 14, 2022 (Actual)
Study Completion Date
October 19, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Azura Ophthalmics
Collaborators
Syneos Health, Cliantha Research

4. Oversight

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

5. Study Description

Brief Summary
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)
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)

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
245 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AZR-MD-001 Low Dose
Arm Type
Experimental
Arm Description
AZR-MD-001 Low Dose will be dosed up to once daily.
Arm Title
AZR-MD-001 Mid Dose
Arm Type
Experimental
Arm Description
AZR-MD-001 Mid Dose will be dosed up to once daily.
Arm Title
AZR-MD-001 High Dose
Arm Type
Experimental
Arm Description
AZR-MD-001 High Dose will be dosed up to once daily.
Arm Title
AZR-MD-001 Vehicle
Arm Type
Sham Comparator
Arm Description
AZR-MD-001 Vehicle will be dosed up to once daily.
Intervention Type
Drug
Intervention Name(s)
AZR-MD-001 Low Dose
Intervention Description
AZR-MD-001 is an ophthalmic ointment
Intervention Type
Drug
Intervention Name(s)
AZR-MD-001 Mid Dose
Intervention Description
AZR-MD-001 is an ophthalmic ointment
Intervention Type
Drug
Intervention Name(s)
AZR-MD-001 High Dose
Intervention Description
AZR-MD-001 is an ophthalmic ointment
Intervention Type
Drug
Intervention Name(s)
AZR-MD-001 Vehicle
Intervention Description
AZR-MD-001 is a vehicle ophthalmic ointment
Primary Outcome Measure Information:
Title
Meibum Gland Secretion Score (MGS)
Description
Change from Baseline in MGS. The MGS can range from 0 (highly abnormal) to 45 (Normal)
Time Frame
Month 3
Title
Meibomian Glands Yielding Liquid Secretion (MGYLS)
Description
Change from Baseline in MGYLS. The MGYLS can range from 0 (abnormal) to 15 (normal)
Time Frame
Month 3
Secondary Outcome Measure Information:
Title
Meibum Gland Secretion Score (MGS)
Description
Change from Baseline in MGS. The MGS can range from 0 (highly abnormal) to 45 (Normal)
Time Frame
Day 14, Month 1, Month 1.5
Title
Meibomian Glands Yielding Liquid Secretion (MGYLS)
Description
Change from Baseline in MGYLS. The MGYLS can range from 0 (abnormal) to 15 (normal)
Time Frame
Day 14, Month 1, Month 1.5

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephanie L Watson
Organizational Affiliation
Save Sight Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vision Eye Institute
City
Chatswood
State/Province
New South Wales
ZIP/Postal Code
2067
Country
Australia
Facility Name
Eye Associates
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2000
Country
Australia
Facility Name
Sydney Eye Hospital
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2000
Country
Australia
Facility Name
School of Optometry and Vision Science, University of New South Wales
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2052
Country
Australia
Facility Name
Queensland University of Technology
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4059
Country
Australia
Facility Name
Queensland Eye Institute
City
South Brisbane
State/Province
Queensland
ZIP/Postal Code
4101
Country
Australia
Facility Name
Ophthalmic Trials Australia
City
Teneriffe
State/Province
Queensland
ZIP/Postal Code
4005
Country
Australia
Facility Name
Eye Laser Specialists
City
Armadale
State/Province
Victoria
ZIP/Postal Code
3143
Country
Australia
Facility Name
Bendigo Eye Clinic
City
Bendigo
State/Province
Victoria
ZIP/Postal Code
3550
Country
Australia
Facility Name
Waverley Eye Clinic
City
Glen Waverley
State/Province
Victoria
ZIP/Postal Code
3150
Country
Australia
Facility Name
Downie Laboratory, Department of Optometry and Vision Sciences
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3053
Country
Australia
Facility Name
Deakin University
City
Waurn Ponds
State/Province
Victoria
ZIP/Postal Code
3216
Country
Australia
Facility Name
Seema Eye Care
City
Calgary
State/Province
Alberta
ZIP/Postal Code
AB T2V 4J2
Country
Canada
Facility Name
FYI Doctors
City
Campbell River
State/Province
British Columbia
Country
Canada
Facility Name
VCH Research Institute.
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 3N8
Country
Canada
Facility Name
Ophthalmology
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6H1H2
Country
Canada
Facility Name
Ocean Optometry
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
NS B3J 1J7
Country
Canada
Facility Name
Miller Optometry
City
Halifax
State/Province
Nova Scotia
Country
Canada
Facility Name
Prism Eye Institute
City
Brampton
State/Province
Ontario
ZIP/Postal Code
6Y 4M3
Country
Canada
Facility Name
Cliantha Research
City
Mississauga
State/Province
Ontario
ZIP/Postal Code
L4W 1A4
Country
Canada
Facility Name
Precision Cornea Centre
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1G 3Y7
Country
Canada
Facility Name
Ottawa Hospital
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Facility Name
FYI Doctors
City
Toronto
State/Province
Ontario
ZIP/Postal Code
L3R 1N1
Country
Canada
Facility Name
Healthpoint
City
Toronto
State/Province
Ontario
ZIP/Postal Code
L6T 0G1
Country
Canada
Facility Name
Eyes on Sheppard Clinic
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M2N3A1
Country
Canada
Facility Name
Toronto Eye Care
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4W 0A7
Country
Canada
Facility Name
Toronto Western Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 2S8
Country
Canada
Facility Name
School of Optometry & Vision Science, University of Waterloo
City
Waterloo
State/Province
Ontario
ZIP/Postal Code
N2L 3G1
Country
Canada
Facility Name
University of Auckland
City
Auckland
ZIP/Postal Code
1023
Country
New Zealand
Facility Name
AucklandEye
City
Auckland
ZIP/Postal Code
1050
Country
New Zealand

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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