Trial Review

Did you know?

The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

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




Registration number
NCT03652051
Ethics application status
Date submitted
27/08/2018
Date registered
29/08/2018
Date last updated
28/02/2024

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
Meibomian Glands Yielding Liquid Secretion (MGYLS)
Timepoint [1] 0 0
Value at month 3 minus value at baseline
Primary outcome [2] 0 0
Ocular Surface Disease Index (OSDI) Total Score
Timepoint [2] 0 0
Value at month 3 minus value at baseline

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 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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
10/09/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
19/10/2022
Sample size
Target
Accrual to date
Final
321
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Vision Eye Institute - Chatswood
Recruitment hospital [2] 0 0
Eye Associates - Sydney
Recruitment hospital [3] 0 0
Sydney Eye Hospital - Sydney
Recruitment hospital [4] 0 0
School of Optometry and Vision Science, University of New South Wales - Sydney
Recruitment hospital [5] 0 0
Queensland University of Technology - Brisbane
Recruitment hospital [6] 0 0
Queensland Eye Institute - South Brisbane
Recruitment hospital [7] 0 0
Ophthalmic Trials Australia - Teneriffe
Recruitment hospital [8] 0 0
Eye Laser Specialists - Armadale
Recruitment hospital [9] 0 0
Bendigo Eye Clinic - Bendigo
Recruitment hospital [10] 0 0
Waverley Eye Clinic - Glen Waverley
Recruitment hospital [11] 0 0
Downie Laboratory, Department of Optometry and Vision Sciences - Melbourne
Recruitment hospital [12] 0 0
Deakin University - Waurn Ponds
Recruitment postcode(s) [1] 0 0
2067 - Chatswood
Recruitment postcode(s) [2] 0 0
2000 - Sydney
Recruitment postcode(s) [3] 0 0
2052 - Sydney
Recruitment postcode(s) [4] 0 0
4059 - Brisbane
Recruitment postcode(s) [5] 0 0
4101 - South Brisbane
Recruitment postcode(s) [6] 0 0
4005 - Teneriffe
Recruitment postcode(s) [7] 0 0
3143 - Armadale
Recruitment postcode(s) [8] 0 0
3550 - Bendigo
Recruitment postcode(s) [9] 0 0
3150 - Glen Waverley
Recruitment postcode(s) [10] 0 0
3053 - Melbourne
Recruitment postcode(s) [11] 0 0
3216 - Waurn Ponds
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
Alberta
Country [2] 0 0
Canada
State/province [2] 0 0
British Columbia
Country [3] 0 0
Canada
State/province [3] 0 0
Nova Scotia
Country [4] 0 0
Canada
State/province [4] 0 0
Ontario
Country [5] 0 0
New Zealand
State/province [5] 0 0
Auckland

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
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Cliantha Research
Address [2] 0 0
Country [2] 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/study/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
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/study/NCT03652051