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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03652051
Other study ID # AZ201801
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date September 10, 2018
Est. completion date October 19, 2022

Study information

Verified date February 2024
Source Azura Ophthalmics
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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)


Description:

AZ201801 is a multicenter, double-masked, vehicle-controlled, randomized, parallel group study carried out in 2 sequentially overlapping cohorts evaluating the safety, efficacy and tolerability of AZR-MD-001 ointment and AZR-MD-001 vehicle in patients with Meibomian Gland Dysfunction (MGD) and evaporative Dry Eye Disease (DED)


Recruitment information / eligibility

Status Completed
Enrollment 321
Est. completion date October 19, 2022
Est. primary completion date September 14, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 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


Intervention

Drug:
AZR-MD-001 Low Dose
AZR-MD-001 is an ophthalmic ointment
AZR-MD-001 Mid Dose
AZR-MD-001 is an ophthalmic ointment
AZR-MD-001 High Dose
AZR-MD-001 is an ophthalmic ointment
AZR-MD-001 Vehicle
AZR-MD-001 is a vehicle ophthalmic ointment

Locations

Country Name City State
Australia Eye Laser Specialists Armadale Victoria
Australia Bendigo Eye Clinic Bendigo Victoria
Australia Queensland University of Technology Brisbane Queensland
Australia Vision Eye Institute Chatswood New South Wales
Australia Waverley Eye Clinic Glen Waverley Victoria
Australia Downie Laboratory, Department of Optometry and Vision Sciences Melbourne Victoria
Australia Queensland Eye Institute South Brisbane Queensland
Australia Eye Associates Sydney New South Wales
Australia School of Optometry and Vision Science, University of New South Wales Sydney New South Wales
Australia Sydney Eye Hospital Sydney New South Wales
Australia Ophthalmic Trials Australia Teneriffe Queensland
Australia Deakin University Waurn Ponds Victoria
Canada Prism Eye Institute Brampton Ontario
Canada Seema Eye Care Calgary Alberta
Canada FYI Doctors Campbell River British Columbia
Canada Miller Optometry Halifax Nova Scotia
Canada Ocean Optometry Halifax Nova Scotia
Canada Cliantha Research Mississauga Ontario
Canada Ottawa Hospital Ottawa Ontario
Canada Precision Cornea Centre Ottawa Ontario
Canada Eyes on Sheppard Clinic Toronto Ontario
Canada FYI Doctors Toronto Ontario
Canada Healthpoint Toronto Ontario
Canada Toronto Eye Care Toronto Ontario
Canada Toronto Western Hospital Toronto Ontario
Canada Ophthalmology Vancouver British Columbia
Canada VCH Research Institute. Vancouver British Columbia
Canada School of Optometry & Vision Science, University of Waterloo Waterloo Ontario
New Zealand AucklandEye Auckland
New Zealand University of Auckland Auckland

Sponsors (3)

Lead Sponsor Collaborator
Azura Ophthalmics Cliantha Research, Syneos Health

Countries where clinical trial is conducted

Australia,  Canada,  New Zealand, 

Outcome

Type Measure Description Time frame Safety issue
Primary Meibomian Glands Yielding Liquid Secretion (MGYLS) Change from Baseline in MGYLS. The MGYLS can range from 0 (abnormal) to 15 (normal) Value at month 3 minus value at baseline
Primary Ocular Surface Disease Index (OSDI) Total Score Change from Baseline in OSDI Total Score. The OSDI Total Score can range from 100 (highly abnormal) to 0 (Normal) Value at month 3 minus value at baseline
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