Evaluation of AXR-270 for the Treatment of Posterior Blepharitis Associated With Meibomian Gland Dysfunction
NCT ID: NCT04469998
Last Updated: 2023-07-21
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
129 participants
INTERVENTIONAL
2020-06-16
2020-12-31
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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AXR-270 Low Dose
AXR-270 Low Dose administered once daily
AXR-270 Low Dose
AXR-270 Topical Eyelid Cream
AXR-270 High Dose
AXR-270 High Dose administered once daily
AXR-270 High Dose
AXR-270 Topical Eyelid Cream
AXR-270 Vehicle
AXR-270 Vehicle administered once daily
AXR-270 Vehicle
AXR-270 Topical Eyelid Cream Vehicle
Interventions
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AXR-270 Low Dose
AXR-270 Topical Eyelid Cream
AXR-270 High Dose
AXR-270 Topical Eyelid Cream
AXR-270 Vehicle
AXR-270 Topical Eyelid Cream Vehicle
Eligibility Criteria
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Inclusion Criteria
Have a clinical diagnosis of moderate to severe MGD (total MGD score between 5 and 14 on a scale with a range between 0 and 15; and clinical severity score of eyelid margin vascularity of at least 2 (moderate))
Have a score of ≥35 on Eye Discomfort using VAS
Have a tFCS score between 3 and 14 on the NEI scale
Have a Schirmer score of \>7 mm
Have a OSDI score \>30
If female, then subject should be non-pregnant and non-lactating
Exclusion Criteria
Subjects with conjunctivitis, keratitis, severe anterior keratitis not related to MGD
Subjects with lid abnormalities
Subjects with ocular fungal, viral or bacterial infection
Subjects unable or unwilling to withhold the use of eyelid scrubs
Subjects with glaucoma and serious systemic disease
18 Years
100 Years
ALL
No
Sponsors
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AxeroVision, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Houman D Hemmati, MD, PhD
Role: STUDY_DIRECTOR
AxeroVision, Inc.
Locations
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AxeroVision, Inc.
Carlsbad, California, United States
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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AXR201901
Identifier Type: -
Identifier Source: org_study_id
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