Evaluation of AZR-MD-001 in Patients With Meibomian Gland Dysfunction (MGD)
NCT ID: NCT04391959
Last Updated: 2022-05-16
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
31 participants
INTERVENTIONAL
2020-07-17
2021-01-06
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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AZR-MD-001 Vehicle
AZR-MD-001 Vehicle will be dosed up to twice weekly.
AZR-MD-001 Vehicle
AZR-MD-001 is a vehicle ophthalmic ointment
AZR-MD-001 Active
AZR-MD-001 Active will be dosed up to twice weekly.
AZR-MD-001 Active
AZR-MD-001 is an active ophthalmic ointment
Interventions
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AZR-MD-001 Active
AZR-MD-001 is an active ophthalmic ointment
AZR-MD-001 Vehicle
AZR-MD-001 is a vehicle ophthalmic ointment
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Avania
INDUSTRY
Azura Ophthalmics
INDUSTRY
Responsible Party
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Principal Investigators
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Jacqueline Tan-Showyin
Role: PRINCIPAL_INVESTIGATOR
School of Optometry and Vision Science, University of New South Wales
Locations
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Fiona Stapleton
Sydney, New South Wales, Australia
Scott A Read
Brisbane, Queensland, Australia
Susan Thackwray
Maroochydore, Queensland, Australia
Jagrut Lallu
Auckland, , New Zealand
Jennifer P Craig
Auckland, , New Zealand
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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AZ202001
Identifier Type: -
Identifier Source: org_study_id
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