Clinical trial NCT03652051: A Multicenter Study Evaluating AZR-MD-001 in Patients With Meibomian Gland Dysfunction and Evaporative Dry Eye Disease (DED)
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Meibomian Gland Dysfunction
Dry Eye
Lead sponsor: Azura Ophthalmics
Sponsor class: INDUSTRY
Collaborators: name: Syneos Health
name: Cliantha Research
First posted: 2018-08-29
Enrollment: 321
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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)

Detailed 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)

Eligibility criteria: 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

Primary outcomes:
measure: Meibomian Glands Yielding Liquid Secretion (MGYLS)
timeFrame: Value at month 3 minus value at baseline
measure: Ocular Surface Disease Index (OSDI) Total Score
timeFrame: Value at month 3 minus value at baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Chatswood
country: Australia
facility: Vision Eye Institute
state: New South Wales
city: Sydney
country: Australia
facility: Eye Associates
state: New South Wales
city: Sydney
country: Australia
facility: Sydney Eye Hospital
state: New South Wales
city: Sydney
country: Australia
facility: School of Optometry and Vision Science, University of New South Wales
state: New South Wales
city: Brisbane
country: Australia
facility: Queensland University of Technology
state: Queensland
city: South Brisbane
country: Australia
facility: Queensland Eye Institute
state: Queensland
city: Teneriffe
country: Australia
facility: Ophthalmic Trials Australia
state: Queensland
city: Armadale
country: Australia
facility: Eye Laser Specialists
state: Victoria
city: Bendigo
country: Australia
facility: Bendigo Eye Clinic
state: Victoria
city: Glen Waverley
country: Australia
facility: Waverley Eye Clinic
state: Victoria
city: Melbourne
country: Australia
facility: Downie Laboratory, Department of Optometry and Vision Sciences
state: Victoria
city: Waurn Ponds
country: Australia
facility: Deakin University
state: Victoria
city: Calgary
country: Canada
facility: Seema Eye Care
state: Alberta
city: Campbell River
country: Canada
facility: FYI Doctors
state: British Columbia
city: Vancouver
country: Canada
facility: VCH Research Institute.
state: British Columbia
city: Vancouver
country: Canada
facility: Ophthalmology
state: British Columbia
city: Halifax
country: Canada
facility: Ocean Optometry
state: Nova Scotia
city: Halifax
country: Canada
facility: Miller Optometry
state: Nova Scotia
city: Brampton
country: Canada
facility: Prism Eye Institute
state: Ontario
city: Mississauga
country: Canada
facility: Cliantha Research
state: Ontario
city: Ottawa
country: Canada
facility: Precision Cornea Centre
state: Ontario
city: Ottawa
country: Canada
facility: Ottawa Hospital
state: Ontario
city: Toronto
country: Canada
facility: FYI Doctors
state: Ontario
city: Toronto
country: Canada
facility: Healthpoint
state: Ontario
city: Toronto
country: Canada
facility: Eyes on Sheppard Clinic
state: Ontario
city: Toronto
country: Canada
facility: Toronto Eye Care
state: Ontario
city: Toronto
country: Canada
facility: Toronto Western Hospital
state: Ontario
city: Waterloo
country: Canada
facility: School of Optometry & Vision Science, University of Waterloo
state: Ontario
city: Auckland
country: New Zealand
facility: University of Auckland
city: Auckland
country: New Zealand
facility: AucklandEye
Study officials:
affiliation: Save Sight Institute
name: Stephanie L Watson
role: PRINCIPAL_INVESTIGATOR
References: