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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04391959




Registration number
NCT04391959
Ethics application status
Date submitted
13/05/2020
Date registered
18/05/2020
Date last updated
16/05/2022

Titles & IDs
Public title
Evaluation of AZR-MD-001 in Patients With Meibomian Gland Dysfunction (MGD)
Scientific title
A Multicenter, Vehicle-controlled, Randomized Study to Evaluate the Safety, Tolerability and Pharmacodynamics of AZR-MD-001 in Patients With Meibomian Gland Dysfunction (MGD)
Secondary ID [1] 0 0
AZ202001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Meibomian Gland Dysfunction 0 0
Condition category
Condition code
Eye 0 0 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - AZR-MD-001 Active
Treatment: Drugs - AZR-MD-001 Vehicle

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

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


Treatment: Drugs: AZR-MD-001 Active
AZR-MD-001 is an active ophthalmic ointment

Treatment: Drugs: AZR-MD-001 Vehicle
AZR-MD-001 is a vehicle ophthalmic ointment
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Meibum Gland Secretion Score (MGS)
Timepoint [1] 0 0
Month 3
Secondary outcome [1] 0 0
Total OSDI
Timepoint [1] 0 0
Day 14 to Month 3

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
17/07/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
6/01/2021
Sample size
Target
Accrual to date
Final
31
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment hospital [1] 0 0
Fiona Stapleton - Sydney
Recruitment hospital [2] 0 0
Scott A Read - Brisbane
Recruitment hospital [3] 0 0
Susan Thackwray - Maroochydore
Recruitment postcode(s) [1] 0 0
- Sydney
Recruitment postcode(s) [2] 0 0
- Brisbane
Recruitment postcode(s) [3] 0 0
- Maroochydore
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Azura Ophthalmics
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Avania
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/ct2/show/NCT04391959
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Jacqueline Tan-Showyin
Address 0 0
School of Optometry and Vision Science, University of New South Wales
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04391959