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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03972501




Registration number
NCT03972501
Ethics application status
Date submitted
29/05/2019
Date registered
3/06/2019

Titles & IDs
Public title
An Evaluation of AZR-MD-001 as Treatment for Meibomian Gland Dysfunction (MGD) or Contact Lens Discomfort (CLD)
Scientific title
A Single-center, Vehicle-controlled, Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of AZR-MD-001 as Adjunctive Therapy to Conventional Therapeutic Treatment for Meibomian Gland Dysfunction (MGD) or Contact Lens Discomfort (CLD)
Secondary ID [1] 0 0
SOVS2019-070
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Meibomian Gland Dysfunction (MGD) 0 0
Contact Lens Discomfort (CLD) 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 Vehicle
Treatment: Drugs - AZR-MD-001 Active Dose

Placebo comparator: AZR-MD-001 Vehicle - AZR-MD-001 Vehicle will be dosed up to once daily.

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


Treatment: Drugs: AZR-MD-001 Vehicle
AZR-MD-001 is an ophthalmic ointment

Treatment: Drugs: AZR-MD-001 Active Dose
AZR-MD-001 is an ophthalmic ointment
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 4 in Meibum Gland Secretion Score (MGS).
Timepoint [1] 0 0
Month 4
Primary outcome [2] 0 0
Primary Efficacy for MGD: Change From Baseline to Month 4 in Meibomian Glands Yielding Liquid Secretion (MGYLS).
Timepoint [2] 0 0
Month 4

Eligibility
Key inclusion criteria
* MGD Patients:

* 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
* TBUT < 10 seconds in both eyes
* CLD Patients:

* 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
* A history of wearing soft contact lenses for at least 6 months
* Wearing of the soft contact lenses for at least 3 weeks before the baseline visit and wore or attempted to wear lenses at least 4 times a week before the baseline visit.
* Symptomatic as defined by an answer of "No" at baseline to the question, "Are you able to comfortably wear your lenses as long as you want?"
* Self-reported history of contact lens dryness/intolerance in the 6 months preceding the baseline visit.
* Baseline CLDEQ-8 score >12
* Contact lens may be use during the study as long as they are removed 15 minutes before dosing and not reinserted until at least 15 minutes after dosing.
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 CLD) or uncontrolled systemic disease
* Patient has glaucoma or ocular hypertension
* Corneal abnormality or disorder that impacts normal spreading of the tear film or corneal integrity
* BCVA worse than 20/40 in either eye at the baseline visit

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
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
4/10/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
11/12/2020
Sample size
Target
Accrual to date
Final
26
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
School of Optometry and Vision Science, University of New South Wales - Sydney
Recruitment postcode(s) [1] 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
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/NCT03972501