A Multicenter Study Evaluating AZR-MD-001 in Patients With Meibomian Gland Dysfunction and Evaporative Dry Eye Disease (DED)

Dry Eye Clinical Trial

Official 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03652051
• Other study ID #: AZ201801
• Status: Completed
• Phase: Phase 2
• 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
• 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

Related Conditions & MeSH terms

• Dry Eye
• Dry Eye Syndromes
• Eye Diseases
• Keratoconjunctivitis Sicca
• Meibomian Gland Dysfunction

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