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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05548491




Registration number
NCT05548491
Ethics application status
Date submitted
17/09/2022
Date registered
21/09/2022
Date last updated
18/10/2023

Titles & IDs
Public title
Safety, Tolerability and Pharmacodynamics of AZR-MD-001 in Contact Lens Discomfort (CLD)
Scientific title
A Two Stage, Multi-center, Vehicle-controlled, Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of AZR-MD-001 and to Determine Common Symptoms in Contact Lens Discomfort (CLD)
Secondary ID [1] 0 0
AZ202201
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Contact Lens Discomfort 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - AZR-MD-001 ointment/semi-solid drug

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

Placebo comparator: AZR-MD-001 vehicle - AZR-MD-001 vehicle


Treatment: Drugs: AZR-MD-001 ointment/semi-solid drug
ointment/semi-solid drug
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Meibomian Glands Yielding Liquid Secretion (MGYLS) Yielding Liquid Secretion (MGYLS)
Timepoint [1] 0 0
3 months
Primary outcome [2] 0 0
Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) fluctuating vision
Timepoint [2] 0 0
3 months
Primary outcome [3] 0 0
Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) total score
Timepoint [3] 0 0
3 months

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.
* A history of wearing soft contact lenses for at least 6 months.
* Screening CLDEQ-8 score >12
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Active ocular infection (bacterial, viral, or fungal).
* Participant is unlikely to follow study instructions or to complete all required study visit(s) or has a condition or situation that in the investigator's opinion, may put the participant at significant risk, may confound the study results, or may interfere significantly with the participant's participation in the study.
* Participant is an employee at the investigational site or is related to any member of the study staff.
* Participation in another clinical trial involving a therapeutic drug or device within the past 30 days

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 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
10/11/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
13/10/2023
Sample size
Target
Accrual to date
Final
67
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment hospital [1] 0 0
University of New South Wales, School of Optometry and Vision Science - Sydney
Recruitment hospital [2] 0 0
Ophthalmic Trials Australia - Teneriffe
Recruitment postcode(s) [1] 0 0
- Sydney
Recruitment postcode(s) [2] 0 0
- Teneriffe

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

Ethics approval
Ethics application status

Summary
Brief summary
A two stage, multi-center, vehicle-controlled study to determine common symptoms in patients with Contact Lens Discomfort (CLD) in Stage 1 and to evaluate the safety, tolerability, and pharmacodynamics of AZR-MD-001 in Stage 2.
Trial website
https://clinicaltrials.gov/study/NCT05548491
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05548491