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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04314362




Registration number
NCT04314362
Ethics application status
Date submitted
17/03/2020
Date registered
19/03/2020

Titles & IDs
Public title
Methods to Enhance AZR-MD-001 for Meibomian Gland Dysfunction (MGD)
Scientific title
A Single-center, Vehicle-controlled, Study to Evaluate Methods to Enhance AZR-MD-001 for Meibomian Gland Dysfunction (MGD)
Secondary ID [1] 0 0
SOVS2020-080
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 ointment/semi-solid drug

Experimental: AZR-MD-001 Active - AZR-MD-001 ointment/semi-solid drug (1.0%)

Experimental: AZR-MD-001 Active + Conventional Treatment - AZR-MD-001 ointment/semi-solid drug (1.0%) plus Hylo-Forte®

Experimental: AZR-MD-001 vehicle - AZR-MD-001 vehicle control


Treatment: Drugs: AZR-MD-001 ointment/semi-solid drug
AZR-MD-001 (1.0%) and suitable excipient
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Primary Efficacy for MGD: Change From Baseline to Month 3 in Meibomian Gland Secretion Score (MGS)
Timepoint [1] 0 0
Month 3

Eligibility
Key inclusion criteria
* Evidence of meibomian gland obstruction (based on a meibomian gland secretion (MGS) score of =12 for 15 glands of the lower lid) in both eyes at the baseline visit
* Reported dry eye signs and symptoms within the past 3 months:

Ocular Surface Disease Index (OSDI) score = 13; TBUT < 10 seconds in both eyes
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) or uncontrolled systemic disease
* Patient has glaucoma or ocular hypertension as demonstrated by an intraocular pressure (IOP) in either eye at screening of =24 mm Hg determined by Goldman applanation tonometry 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 (keratoconus, pterygia, scarring) or corneal integrity
* Recent (within the past 3 months of the baseline visit) ocular surgery, trauma, herpes, or recurrent inflammation
* Contact lens use anticipated during the study

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 administering the treatment/s

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
14/07/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
6/01/2021
Sample size
Target
Accrual to date
Final
32
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Fiona Stapleton - Sydney
Recruitment postcode(s) [1] 0 0
- 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
The University of New South Wales
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
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/NCT04314362