Back to resultsEvaluation of AXR-270 for the Treatment of Posterior Blepharitis Associated With Meibomian Gland Dysfunction
Primary Purpose
Posterior Blepharitis, Meibomian Gland Dysfunction
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
AXR-270 Low Dose
AXR-270 High Dose
AXR-270 Vehicle
Sponsored by
About this trial
This is an interventional treatment trial for Posterior Blepharitis focused on measuring Meibomian Gland Dysfunction, Posterior Blepharitis
Eligibility Criteria
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
Sites / Locations
- AxeroVision, Inc.
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
AXR-270 Low Dose
AXR-270 High Dose
AXR-270 Vehicle
Arm Description
AXR-270 Low Dose administered once daily
AXR-270 High Dose administered once daily
AXR-270 Vehicle administered once daily
Outcomes
Primary Outcome Measures
Adverse Events
Incidence of treatment emergent ocular and systemic adverse events (TEAE)
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04469998
Brief Title
Evaluation of AXR-270 for the Treatment of Posterior Blepharitis Associated With Meibomian Gland Dysfunction
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
June 16, 2020 (Actual)
Primary Completion Date
December 1, 2020 (Actual)
Study Completion Date
December 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AxeroVision, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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)
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posterior Blepharitis, Meibomian Gland Dysfunction
Keywords
Meibomian Gland Dysfunction, Posterior Blepharitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
129 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AXR-270 Low Dose
Arm Type
Experimental
Arm Description
AXR-270 Low Dose administered once daily
Arm Title
AXR-270 High Dose
Arm Type
Experimental
Arm Description
AXR-270 High Dose administered once daily
Arm Title
AXR-270 Vehicle
Arm Type
Placebo Comparator
Arm Description
AXR-270 Vehicle administered once daily
Intervention Type
Drug
Intervention Name(s)
AXR-270 Low Dose
Intervention Description
AXR-270 Topical Eyelid Cream
Intervention Type
Drug
Intervention Name(s)
AXR-270 High Dose
Intervention Description
AXR-270 Topical Eyelid Cream
Intervention Type
Drug
Intervention Name(s)
AXR-270 Vehicle
Intervention Description
AXR-270 Topical Eyelid Cream Vehicle
Primary Outcome Measure Information:
Title
Adverse Events
Description
Incidence of treatment emergent ocular and systemic adverse events (TEAE)
Time Frame
22 Days
Secondary Outcome Measure Information:
Title
Total Meibomian Gland Dysfunction Score
Description
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.
Time Frame
22 Days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Houman D Hemmati, MD, PhD
Organizational Affiliation
AxeroVision, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
AxeroVision, Inc.
City
Carlsbad
State/Province
California
ZIP/Postal Code
92008
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evaluation of AXR-270 for the Treatment of Posterior Blepharitis Associated With Meibomian Gland Dysfunction
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