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

A Phase I/II, Randomized, Double-Masked, Vehicle-Controlled Study of the Safety, Tolerability, and Efficacy of AXR-270 Topical Eyelid Cream in Treating Posterior Blepharitis Associated With Meibomian Gland Dysfunction

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

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

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