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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

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
Trial website
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT03652051