Evaluation of AXR-270 for the Treatment of Posterior Blepharitis Associated With Meibomian Gland Dysfunction

AxeroVision

Status and phase: Completed; Phase 2

Conditions: Meibomian Gland Dysfunction; Posterior Blepharitis

Treatments: Drug: AXR-270 High Dose; Drug: AXR-270 Low Dose; Drug: AXR-270 Vehicle

Study type: Interventional

Funder types: Industry

Identifiers

NCT04469998

AXR201901

Details and patient eligibility

About

This study will evaluate the safety, tolerability and efficacy of AXR-270 Cream in treating posterior blepharitis associated with Meibomian Gland Disease (MGD)

Full 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 meibomian gland dysfunction

Enrollment: 129 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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 criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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129 participants in 3 patient groups, including a placebo group

AXR-270 Low Dose

Experimental group

Description:

AXR-270 Low Dose administered once daily

Treatment:

Drug: AXR-270 Low Dose

AXR-270 High Dose

Experimental group

Description:

AXR-270 High Dose administered once daily

Treatment:

Drug: AXR-270 High Dose

AXR-270 Vehicle

Placebo Comparator group

Description:

AXR-270 Vehicle administered once daily

Treatment:

Drug: AXR-270 Vehicle