Meibomian Gland Dysfunction, Posterior Blepharitis
Conditions
Keywords
Meibomian Gland Dysfunction, Posterior Blepharitis
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
Interventions
DRUGAXR-270 Low Dose
AXR-270 Topical Eyelid Cream
DRUGAXR-270 High Dose
AXR-270 Topical Eyelid Cream
DRUGAXR-270 Vehicle
AXR-270 Topical Eyelid Cream Vehicle
Sponsors
AxeroVision, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events | 22 Days | Incidence of treatment emergent ocular and systemic adverse events (TEAE) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total Meibomian Gland Dysfunction Score | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| AXR-270 Low Dose AXR-270 Low Dose administered once daily
AXR-270 Low Dose: AXR-270 Topical Eyelid Cream | 43 |
| AXR-270 High Dose AXR-270 High Dose administered once daily
AXR-270 High Dose: AXR-270 Topical Eyelid Cream | 44 |
| AXR-270 Vehicle AXR-270 Vehicle administered once daily
AXR-270 Vehicle: AXR-270 Topical Eyelid Cream Vehicle | 42 |
| Total | 129 |
Baseline characteristics
| Characteristic | Total | AXR-270 Low Dose | AXR-270 High Dose | AXR-270 Vehicle |
|---|---|---|---|---|
| Age, Continuous | 65.4 years STANDARD_DEVIATION 14.3 | 68.0 years STANDARD_DEVIATION 8.7 | 63.9 years STANDARD_DEVIATION 17.4 | 64.3 years STANDARD_DEVIATION 15.4 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian | 5 Participants | 0 Participants | 3 Participants | 2 Participants |
| Race/Ethnicity, Customized Black or African American | 7 Participants | 2 Participants | 2 Participants | 3 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 1 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized White | 115 Participants | 40 Participants | 38 Participants | 37 Participants |
| Region of Enrollment United States | 129 participants | 43 participants | 44 participants | 42 participants |
| Sex: Female, Male Female | 92 Participants | 34 Participants | 28 Participants | 30 Participants |
| Sex: Female, Male Male | 37 Participants | 9 Participants | 16 Participants | 12 Participants |
| Total Meibomian Gland Dysfunction Score | 9.7 units on a scale STANDARD_DEVIATION 2.1 | 9.7 units on a scale STANDARD_DEVIATION 1.6 | 9.5 units on a scale STANDARD_DEVIATION 2.3 | 10.0 units on a scale STANDARD_DEVIATION 2.3 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 42 | 0 / 43 | 0 / 43 |
| other Total, other adverse events | 1 / 42 | 1 / 43 | 4 / 43 |
| serious Total, serious adverse events | 0 / 42 | 0 / 43 | 0 / 43 |
Outcome results
Primary
Adverse Events
Incidence of treatment emergent ocular and systemic adverse events (TEAE)
Time frame: 22 Days
Population: Safety Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| AXR-270 Low Dose | Adverse Events | Non-ocular Serious TEAEs | 0 adverse events |
| AXR-270 Low Dose | Adverse Events | Ocular TEAEs | 0 adverse events |
| AXR-270 Low Dose | Adverse Events | Ocular Serious TEAEs | 0 adverse events |
| AXR-270 Low Dose | Adverse Events | Non-ocular TEAEs | 1 adverse events |
| AXR-270 High Dose | Adverse Events | Non-ocular TEAEs | 1 adverse events |
| AXR-270 High Dose | Adverse Events | Non-ocular Serious TEAEs | 0 adverse events |
| AXR-270 High Dose | Adverse Events | Ocular Serious TEAEs | 0 adverse events |
| AXR-270 High Dose | Adverse Events | Ocular TEAEs | 0 adverse events |
| AXR-270 Vehicle | Adverse Events | Non-ocular TEAEs | 2 adverse events |
| AXR-270 Vehicle | Adverse Events | Ocular TEAEs | 4 adverse events |
| AXR-270 Vehicle | Adverse Events | Ocular Serious TEAEs | 0 adverse events |
| AXR-270 Vehicle | Adverse Events | Non-ocular Serious TEAEs | 0 adverse events |
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.
Time frame: 22 Days
Population: Full Analysis Set (Intent-to-Treat)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AXR-270 Low Dose | Total Meibomian Gland Dysfunction Score | -0.9 score on a scale | Standard Deviation 2.3 |
| AXR-270 High Dose | Total Meibomian Gland Dysfunction Score | -1.7 score on a scale | Standard Deviation 2.1 |
| AXR-270 Vehicle | Total Meibomian Gland Dysfunction Score | -2.1 score on a scale | Standard Deviation 2.6 |