A Multicenter Study Evaluating AZR-MD-001 in Patients With Meibomian Gland Dysfunction and Evaporative Dry Eye Disease (DED)
NCT ID: NCT03652051
Last Updated: 2024-02-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
321 participants
INTERVENTIONAL
2018-09-10
2022-10-19
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
QUADRUPLE
Study Groups
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AZR-MD-001 Low Dose
AZR-MD-001 Low Dose will be dosed up to once daily.
AZR-MD-001 Low Dose
AZR-MD-001 is an ophthalmic ointment
AZR-MD-001 Mid Dose
AZR-MD-001 Mid Dose will be dosed up to once daily.
AZR-MD-001 Mid Dose
AZR-MD-001 is an ophthalmic ointment
AZR-MD-001 High Dose
AZR-MD-001 High Dose will be dosed up to once daily.
AZR-MD-001 High Dose
AZR-MD-001 is an ophthalmic ointment
AZR-MD-001 Vehicle
AZR-MD-001 Vehicle will be dosed up to once daily.
AZR-MD-001 Vehicle
AZR-MD-001 is a vehicle ophthalmic ointment
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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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Syneos Health
OTHER
Cliantha Research
OTHER
Azura Ophthalmics
INDUSTRY
Responsible Party
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Principal Investigators
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Stephanie L Watson
Role: PRINCIPAL_INVESTIGATOR
Save Sight Institute
Locations
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Vision Eye Institute
Chatswood, New South Wales, Australia
Eye Associates
Sydney, New South Wales, Australia
Sydney Eye Hospital
Sydney, New South Wales, Australia
School of Optometry and Vision Science, University of New South Wales
Sydney, New South Wales, Australia
Queensland University of Technology
Brisbane, Queensland, Australia
Queensland Eye Institute
South Brisbane, Queensland, Australia
Ophthalmic Trials Australia
Teneriffe, Queensland, Australia
Eye Laser Specialists
Armadale, Victoria, Australia
Bendigo Eye Clinic
Bendigo, Victoria, Australia
Waverley Eye Clinic
Glen Waverley, Victoria, Australia
Downie Laboratory, Department of Optometry and Vision Sciences
Melbourne, Victoria, Australia
Deakin University
Waurn Ponds, Victoria, Australia
Seema Eye Care
Calgary, Alberta, Canada
FYI Doctors
Campbell River, British Columbia, Canada
VCH Research Institute.
Vancouver, British Columbia, Canada
Ophthalmology
Vancouver, British Columbia, Canada
Ocean Optometry
Halifax, Nova Scotia, Canada
Miller Optometry
Halifax, Nova Scotia, Canada
Prism Eye Institute
Brampton, Ontario, Canada
Cliantha Research
Mississauga, Ontario, Canada
Precision Cornea Centre
Ottawa, Ontario, Canada
Ottawa Hospital
Ottawa, Ontario, Canada
FYI Doctors
Toronto, Ontario, Canada
Healthpoint
Toronto, Ontario, Canada
Eyes on Sheppard Clinic
Toronto, Ontario, Canada
Toronto Eye Care
Toronto, Ontario, Canada
Toronto Western Hospital
Toronto, Ontario, Canada
School of Optometry & Vision Science, University of Waterloo
Waterloo, Ontario, Canada
University of Auckland
Auckland, , New Zealand
AucklandEye
Auckland, , New Zealand
Countries
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References
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Watson SL, Jones LW, Stapleton F, Hinds M, Ng A, Tan J, Alster Y, Bosworth C, Rafaeli O, DePuy V; CELESTIAL STUDY Group. Efficacy and safety of AZR-MD-001 selenium sulfide ophthalmic ointment in adults with meibomian gland dysfunction: A vehicle-controlled, randomized clinical trial. Ocul Surf. 2023 Jul;29:537-546. doi: 10.1016/j.jtos.2023.07.002. Epub 2023 Jul 20.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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AZ201801
Identifier Type: -
Identifier Source: org_study_id
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