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

AXR201901

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

2020-06-16

2020-12-01

2020-12-31

Completed

Early phase I

129

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 129, 'type': 'ACTUAL'}}

2023-07-21