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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03652051




Registration number
NCT03652051
Ethics application status
Date submitted
27/08/2018
Date registered
29/08/2018
Date last updated
19/03/2020

Titles & IDs
Public title
A Multicenter Study Evaluating AZR-MD-001 in Patients With Meibomian Gland Dysfunction and Evaporative Dry Eye Disease (DED)
Scientific 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)
Secondary ID [1] 0 0
AZ201801
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Meibomian Gland Dysfunction 0 0
Dry Eye 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 Low Dose
Treatment: Drugs - AZR-MD-001 Mid Dose
Treatment: Drugs - AZR-MD-001 High Dose
Treatment: Drugs - AZR-MD-001 Vehicle

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

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

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

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


Treatment: Drugs: AZR-MD-001 Low Dose
AZR-MD-001 is an ophthalmic ointment

Treatment: Drugs: AZR-MD-001 Mid Dose
AZR-MD-001 is an ophthalmic ointment

Treatment: Drugs: AZR-MD-001 High Dose
AZR-MD-001 is an 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) - Change from Baseline in MGS. The MGS can range from 0 (highly abnormal) to 45 (Normal)
Timepoint [1] 0 0
Month 3
Primary outcome [2] 0 0
Meibomian Glands Yielding Liquid Secretion (MGYLS) - Change from Baseline in MGYLS. The MGYLS can range from 0 (abnormal) to 15 (normal)
Timepoint [2] 0 0
Month 3
Secondary outcome [1] 0 0
Meibum Gland Secretion Score (MGS) - Change from Baseline in MGS. The MGS can range from 0 (highly abnormal) to 45 (Normal)
Timepoint [1] 0 0
Day 14, Month 1, Month 1.5
Secondary outcome [2] 0 0
Meibomian Glands Yielding Liquid Secretion (MGYLS) - Change from Baseline in MGYLS. The MGYLS can range from 0 (abnormal) to 15 (normal)
Timepoint [2] 0 0
Day 14, Month 1, Month 1.5

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
Gender
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 administering 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
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Eye Associates - Sydney
Recruitment hospital [2] 0 0
Sydney Eye Hospital - Sydney
Recruitment hospital [3] 0 0
School of Optometry and Vision Science, University of New South Wales - Sydney
Recruitment postcode(s) [1] 0 0
2000 - Sydney
Recruitment postcode(s) [2] 0 0
2052 - Sydney

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

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/show/NCT03652051
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Stephanie L Watson
Address 0 0
Save Sight Institute
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Charles Bosworth, PhD
Address 0 0
Country 0 0
Phone 0 0
714-559-8435
Fax 0 0
Email 0 0
charles.bosworth@azuraophthalmics.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03652051