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

July 19, 2023 updated by: AxeroVision, Inc.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

129

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Carlsbad, California, United States, 92008
        • AxeroVision, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse Events
Time Frame: 22 Days
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
Time Frame: 22 Days

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AxeroVision, Inc.

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 16, 2020

Primary Completion (Actual)

December 1, 2020

Study Completion (Actual)

December 31, 2020

Study Registration Dates

First Submitted

July 9, 2020

First Submitted That Met QC Criteria

July 13, 2020

First Posted (Actual)

July 14, 2020

Study Record Updates

Last Update Posted (Actual)

July 21, 2023

Last Update Submitted That Met QC Criteria

July 19, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AXR201901

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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