Evaluation of AXR-270 for the Treatment of Posterior Blepharitis Associated With Meibomian Gland Dysfunction
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
1 other identifier
interventional
129
1 country
1
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jun 2020
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 16, 2020
CompletedFirst Submitted
Initial submission to the registry
July 9, 2020
CompletedFirst Posted
Study publicly available on registry
July 14, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2020
CompletedResults Posted
Study results publicly available
July 21, 2023
CompletedJuly 21, 2023
July 1, 2023
6 months
July 9, 2020
January 4, 2023
July 19, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Adverse Events
Incidence of treatment emergent ocular and systemic adverse events (TEAE)
22 Days
Secondary Outcomes (1)
Total Meibomian Gland Dysfunction Score
22 Days
Study Arms (3)
AXR-270 Low Dose
EXPERIMENTALAXR-270 Low Dose administered once daily
AXR-270 High Dose
EXPERIMENTALAXR-270 High Dose administered once daily
AXR-270 Vehicle
PLACEBO COMPARATORAXR-270 Vehicle administered once daily
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
AxeroVision, Inc.
Carlsbad, California, 92008, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Houman Hemmati
- Organization
- AxeroVision, Inc.
Study Officials
- STUDY DIRECTOR
Houman D Hemmati, MD, PhD
AxeroVision, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 9, 2020
First Posted
July 14, 2020
Study Start
June 16, 2020
Primary Completion
December 1, 2020
Study Completion
December 31, 2020
Last Updated
July 21, 2023
Results First Posted
July 21, 2023
Record last verified: 2023-07
Data Sharing
- IPD Sharing
- Will not share