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

Study Overview
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Brief Summary
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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
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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

Official Title
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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

Conditions
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Posterior Blepharitis, Meibomian Gland Dysfunction

Intervention / Treatment
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* Drug: AXR-270 Low Dose
* Drug: AXR-270 High Dose
* Drug: AXR-270 Vehicle


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AXR-270 Low Dose<br>AXR-270 Low Dose administered once daily | Drug: AXR-270 Low Dose<br>* AXR-270 Topical Eyelid Cream<br>|
| Experimental: AXR-270 High Dose<br>AXR-270 High Dose administered once daily | Drug: AXR-270 High Dose<br>* AXR-270 Topical Eyelid Cream<br>|
| Placebo Comparator: AXR-270 Vehicle<br>AXR-270 Vehicle administered once daily | Drug: AXR-270 Vehicle<br>* AXR-270 Topical Eyelid Cream Vehicle<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events | Incidence of treatment emergent ocular and systemic adverse events (TEAE) | 22 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Meibomian Gland Dysfunction Score | Change from Baseline in total MGD score (Study Eyelid): The total MGD score is the sum of secretion of 5 central glands on the upper and lower eyelids. Each gland orifice was scored from 0-3. The total score range was from 0-15 per eyelid. The numbers reported are for the Study Eyelid of each subject (=eyelid with higher sum score of the Total MGD score and Vascularity of Eyelid Margin score at baseline). Greater negative scores indicate a better outcome. Scores: 0 = clear/slightly yellow; 1 = opaque/yellow, whitish, particulate; 2 = paste; 3 = none/occluded. | 22 Days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Meibomian Gland Dysfunction, Posterior Blepharitis