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

• Sponsor: AxeroVision, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04469998
• Collaborator: (none)
• Enrollment: 129
• Location: 1
• Arms: 3
• Actual Duration (Months): 6.5
• Patients Per Site Per Month: 19.8

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Posterior Blepharitis; Meibomian Gland Dysfunction	Drug: AXR-270 Low Dose; Drug: AXR-270 High Dose; Drug: AXR-270 Vehicle	Phase 2

Detailed 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

Study Design

• Study Type: Interventional
• Actual Enrollment: 129 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Jun 16, 2020
• Actual Primary Completion Date: Dec 1, 2020
• Actual Study Completion Date: Dec 31, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: AXR-270 Low Dose AXR-270 Low Dose administered once daily	Drug: AXR-270 Low Dose; AXR-270 Topical Eyelid Cream
Experimental: AXR-270 High Dose AXR-270 High Dose administered once daily	Drug: AXR-270 High Dose; AXR-270 Topical Eyelid Cream
Placebo Comparator: AXR-270 Vehicle AXR-270 Vehicle administered once daily	Drug: AXR-270 Vehicle; AXR-270 Topical Eyelid Cream Vehicle

Outcome Measures

Primary Outcome Measures

1. Adverse Events [22 Days]

   Incidence of ocular and systemic adverse events

Secondary Outcome Measures

1. Total Meibomian Gland Dysfunction Score [22 Days]

   Change from Baseline in total MGD score

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 100 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

Male or female, 18 years or older

Have a clinical diagnosis of moderate to severe MGD

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, conjunctivitis, keratitis

Subjects with lid abnormalities

Subjects unable or unwilling to withhold the use of eyelid scrubs

Subjects with glaucoma and serious systemic disease

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	AxeroVision, Inc.	Carlsbad	California	United States	92008

Sponsors and Collaborators

• AxeroVision, Inc.

Investigators

• Study Director: Houman D Hemmati, MD, PhD, AxeroVision, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: AxeroVision, Inc.
• ClinicalTrials.gov Identifier: NCT04469998
• Other Study ID Numbers: AXR201901
• First Posted: Jul 14, 2020
• Last Update Posted: Jan 13, 2021
• Last Verified: Sep 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by AxeroVision, Inc.: Meibomian Gland Dysfunction; Posterior Blepharitis
• Additional relevant MeSH terms: Meibomian Gland Dysfunction; Blepharitis

Study Results

No Results Posted as of Jan 13, 2021