NCT04391959

Brief Summary

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jul 2020

Shorter than P25 for phase_2

Geographic Reach
2 countries

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 13, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 18, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

July 17, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 6, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 6, 2021

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

May 16, 2022

Completed
Last Updated

May 16, 2022

Status Verified

January 1, 2021

Enrollment Period

6 months

First QC Date

May 13, 2020

Results QC Date

December 15, 2021

Last Update Submit

March 1, 2022

Conditions

Meibomian Gland Dysfunction

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Total OSDI

    Day 14 to Month 3

Study Arms (2)

AZR-MD-001 Vehicle

EXPERIMENTAL

AZR-MD-001 Vehicle will be dosed up to twice weekly.

Drug: AZR-MD-001 Vehicle

AZR-MD-001 Active

EXPERIMENTAL

AZR-MD-001 Active will be dosed up to twice weekly.

Drug: AZR-MD-001 Active

Interventions

AZR-MD-001 ActiveDRUG

AZR-MD-001 is an active ophthalmic ointment

Also known as: AZR-MD-001 is an ophthalmic ointment
AZR-MD-001 Active
AZR-MD-001 VehicleDRUG

AZR-MD-001 is a vehicle ophthalmic ointment

Also known as: AZR-MD-001 Vehicle is an ophthalmic ointment
AZR-MD-001 Vehicle

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Fiona Stapleton

Sydney, New South Wales, Australia

Location

Scott A Read

Brisbane, Queensland, Australia

Location

Susan Thackwray

Maroochydore, Queensland, Australia

Location

Jagrut Lallu

Auckland, New Zealand

Location

Jennifer P Craig

Auckland, New Zealand

Location

MeSH Terms

Conditions

Meibomian Gland Dysfunction

Condition Hierarchy (Ancestors)

Eyelid DiseasesEye Diseases

Results Point of Contact

Title
Chief Medical Officer
Organization
Azura Ophthalmics
charles.bosworth@azuraophthalmics.com
17145598435

Study Officials

  • Jacqueline Tan-Showyin

    School of Optometry and Vision Science, University of New South Wales

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 13, 2020

First Posted

May 18, 2020

Study Start

July 17, 2020

Primary Completion

January 6, 2021

Study Completion

January 6, 2021

Last Updated

May 16, 2022

Results First Posted

May 16, 2022

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

NZ(2)AU(3)