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

Meibomian Gland Dysfunction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04469998
• Other study ID #: AXR201901
• Status: Completed
• Phase: Phase 2
• Start date: June 16, 2020
• Est. completion date: December 31, 2020

Study information

• Verified date: July 2023
• Source: AxeroVision, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 129
• Est. completion date: December 31, 2020
• Est. primary completion date: December 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Blepharitis
• Meibomian Gland Dysfunction
• Posterior Blepharitis

Intervention

Drug:
• AXR-270 Low Dose
AXR-270 Topical Eyelid Cream
• AXR-270 High Dose
AXR-270 Topical Eyelid Cream
• AXR-270 Vehicle
AXR-270 Topical Eyelid Cream Vehicle

Locations

Country	Name	City	State
United States	AxeroVision, Inc.	Carlsbad	California

Sponsors (1)

Lead Sponsor	Collaborator
AxeroVision, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse Events	Incidence of treatment emergent ocular and systemic adverse events (TEAE)	22 Days
Secondary	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