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)
Verified date | February 2024 |
Source | Azura Ophthalmics |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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)
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Azura Ophthalmics | Cliantha Research, Syneos Health |
Australia, Canada, New Zealand,
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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