NCT03652051

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)

Trial Health

90
On Track

Trial Health Score

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

Enrollment
321

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Sep 2018

Typical duration for phase_2

Geographic Reach
3 countries

30 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

August 27, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 29, 2018

Completed
12 days until next milestone

Study Start

First participant enrolled

September 10, 2018

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 14, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 19, 2022

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

February 28, 2024

Completed
Last Updated

February 28, 2024

Status Verified

February 1, 2024

Enrollment Period

4 years

First QC Date

August 27, 2018

Results QC Date

October 16, 2023

Last Update Submit

February 14, 2024

Conditions

Meibomian Gland DysfunctionDry Eye

Outcome Measures

Primary Outcomes (2)

  • Meibomian Glands Yielding Liquid Secretion (MGYLS)

    Change from Baseline in MGYLS. The MGYLS can range from 0 (abnormal) to 15 (normal)

    Value at month 3 minus value at baseline

  • Ocular Surface Disease Index (OSDI) Total Score

    Change from Baseline in OSDI Total Score. The OSDI Total Score can range from 100 (highly abnormal) to 0 (Normal)

    Value at month 3 minus value at baseline

Study Arms (4)

AZR-MD-001 Low Dose

EXPERIMENTAL

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

Drug: AZR-MD-001 Low Dose

AZR-MD-001 Mid Dose

EXPERIMENTAL

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

Drug: AZR-MD-001 Mid Dose

AZR-MD-001 High Dose

EXPERIMENTAL

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

Drug: AZR-MD-001 High Dose

AZR-MD-001 Vehicle

SHAM COMPARATOR

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

Drug: AZR-MD-001 Vehicle

Interventions

AZR-MD-001 Low DoseDRUG

AZR-MD-001 is an ophthalmic ointment

AZR-MD-001 Low Dose
AZR-MD-001 Mid DoseDRUG

AZR-MD-001 is an ophthalmic ointment

AZR-MD-001 Mid Dose
AZR-MD-001 High DoseDRUG

AZR-MD-001 is an ophthalmic ointment

AZR-MD-001 High Dose
AZR-MD-001 VehicleDRUG

AZR-MD-001 is a vehicle 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, 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

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 (30)

Vision Eye Institute

Chatswood, New South Wales, 2067, Australia

Location

Eye Associates

Sydney, New South Wales, 2000, Australia

Location

Sydney Eye Hospital

Sydney, New South Wales, 2000, Australia

Location

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

Sydney, New South Wales, 2052, Australia

Location

Queensland University of Technology

Brisbane, Queensland, 4059, Australia

Location

Queensland Eye Institute

South Brisbane, Queensland, 4101, Australia

Location

Ophthalmic Trials Australia

Teneriffe, Queensland, 4005, Australia

Location

Eye Laser Specialists

Armadale, Victoria, 3143, Australia

Location

Bendigo Eye Clinic

Bendigo, Victoria, 3550, Australia

Location

Waverley Eye Clinic

Glen Waverley, Victoria, 3150, Australia

Location

Downie Laboratory, Department of Optometry and Vision Sciences

Melbourne, Victoria, 3053, Australia

Location

Deakin University

Waurn Ponds, Victoria, 3216, Australia

Location

Seema Eye Care

Calgary, Alberta, AB T2V 4J2, Canada

Location

FYI Doctors

Campbell River, British Columbia, Canada

Location

VCH Research Institute.

Vancouver, British Columbia, V5Z 3N8, Canada

Location

Ophthalmology

Vancouver, British Columbia, V6H1H2, Canada

Location

Ocean Optometry

Halifax, Nova Scotia, NS B3J 1J7, Canada

Location

Miller Optometry

Halifax, Nova Scotia, Canada

Location

Prism Eye Institute

Brampton, Ontario, 6Y 4M3, Canada

Location

Cliantha Research

Mississauga, Ontario, L4W 1A4, Canada

Location

Precision Cornea Centre

Ottawa, Ontario, K1G 3Y7, Canada

Location

Ottawa Hospital

Ottawa, Ontario, K1H 8L6, Canada

Location

FYI Doctors

Toronto, Ontario, L3R 1N1, Canada

Location

Healthpoint

Toronto, Ontario, L6T 0G1, Canada

Location

Eyes on Sheppard Clinic

Toronto, Ontario, M2N3A1, Canada

Location

Toronto Eye Care

Toronto, Ontario, M4W 0A7, Canada

Location

Toronto Western Hospital

Toronto, Ontario, M5T 2S8, Canada

Location

School of Optometry & Vision Science, University of Waterloo

Waterloo, Ontario, N2L 3G1, Canada

Location

University of Auckland

Auckland, 1023, New Zealand

Location

AucklandEye

Auckland, 1050, New Zealand

Location

Related Publications (1)

  • Watson SL, Jones LW, Stapleton F, Hinds M, Ng A, Tan J, Alster Y, Bosworth C, Rafaeli O, DePuy V; CELESTIAL STUDY Group. Efficacy and safety of AZR-MD-001 selenium sulfide ophthalmic ointment in adults with meibomian gland dysfunction: A vehicle-controlled, randomized clinical trial. Ocul Surf. 2023 Jul;29:537-546. doi: 10.1016/j.jtos.2023.07.002. Epub 2023 Jul 20.

    PMID: 37478969DERIVED

MeSH Terms

Conditions

Meibomian Gland DysfunctionDry Eye Syndromes

Condition Hierarchy (Ancestors)

Eyelid DiseasesEye DiseasesLacrimal Apparatus Diseases

Results Point of Contact

Title
Charles Bosworth
Organization
Azura Ophthalmics
charles.bosworth@azuraophthalmics.com
17145598435

Study Officials

  • Stephanie L Watson

    Save Sight Institute

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

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

Study Record Dates

First Submitted

August 27, 2018

First Posted

August 29, 2018

Study Start

September 10, 2018

Primary Completion

September 14, 2022

Study Completion

October 19, 2022

Last Updated

February 28, 2024

Results First Posted

February 28, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

CA(16)NZ(2)AU(12)