Status:
COMPLETED
Evaluation of AXR-270 for the Treatment of Posterior Blepharitis Associated With Meibomian Gland Dysfunction
Lead Sponsor:
AxeroVision, Inc.
Conditions:
Posterior Blepharitis
Meibomian Gland Dysfunction
Eligibility:
All Genders
18-100 years
Phase:
PHASE2
Brief Summary
This study will evaluate the safety, tolerability and efficacy of AXR-270 Cream in treating posterior blepharitis associated with Meibomian Gland Disease (MGD)
Detailed Description
AXR201901 is a multicenter, randomized, double-masked, vehicle-controlled study of AXR-270 cream and AXR-270 vehicle in subjects with signs and symptoms of posterior blepharitis associated with meibom...
Eligibility Criteria
Inclusion
- Male or female, 18 years or older
- 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
- Subjects with iritis, uveitis in either eye
- 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
Key Trial Info
Start Date :
June 16 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2020
Estimated Enrollment :
129 Patients enrolled
Trial Details
Trial ID
NCT04469998
Start Date
June 16 2020
End Date
December 31 2020
Last Update
July 21 2023
Active Locations (1)
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1
AxeroVision, Inc.
Carlsbad, California, United States, 92008