Phase 2 N=129 Randomized Quadruple-blind Treatment

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

Posterior Blepharitis · Meibomian Gland Dysfunction

Bottom Line

View on ClinicalTrials.gov: NCT04469998 ↗

Enrolled (actual)

129

Serious AEs

0.0%

Results posted

Jul 2023

Primary outcome: Primary: Adverse Events — 1; 1; 2; 0 adverse events

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: AXR-270 Low Dose (Drug); AXR-270 High Dose (Drug); AXR-270 Vehicle (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: AxeroVision, Inc.
Primary completion: Dec 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY Adverse Events	1; 1; 2; 0; 0; 0	—
SECONDARY Total Meibomian Gland Dysfunction Score	-0.9; -1.7; -2.1	—

Summary

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

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04469998). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.