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This study will evaluate the safety, tolerability and efficacy of AXR-270 Cream in treating posterior blepharitis associated with Meibomian Gland Disease (MGD)
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AXR-270 Low Dose | Experimental | AXR-270 Low Dose administered once daily |
|
| AXR-270 High Dose | Experimental | AXR-270 High Dose administered once daily |
|
| AXR-270 Vehicle | Placebo Comparator | AXR-270 Vehicle administered once daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AXR-270 Low Dose | Drug | AXR-270 Topical Eyelid Cream |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | Incidence of treatment emergent ocular and systemic adverse events (TEAE) | 22 Days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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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
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| Name | Affiliation | Role |
|---|---|---|
| Houman D Hemmati, MD, PhD | AxeroVision, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AxeroVision, Inc. | Carlsbad | California | 92008 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | AXR-270 Low Dose | AXR-270 Low Dose administered once daily AXR-270 Low Dose: AXR-270 Topical Eyelid Cream 0.2% |
| FG001 | AXR-270 High Dose | AXR-270 High Dose administered once daily AXR-270 High Dose: AXR-270 Topical Eyelid Cream 2% |
| FG002 | AXR-270 Vehicle | AXR-270 Vehicle administered once daily AXR-270 Vehicle: AXR-270 Topical Eyelid Cream Vehicle |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Full Analysis Set (ITT Population) |
| |||||||||||||
| Safety Set (as Treated) |
|
Full analysis set
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| ID | Title | Description |
|---|---|---|
| BG000 | AXR-270 Low Dose | AXR-270 Low Dose administered once daily AXR-270 Low Dose: AXR-270 Topical Eyelid Cream |
| BG001 | AXR-270 High Dose | AXR-270 High Dose administered once daily AXR-270 High Dose: AXR-270 Topical Eyelid Cream |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Adverse Events | Incidence of treatment emergent ocular and systemic adverse events (TEAE) | Safety Set | Posted | Number | adverse events | 22 Days |
|
22 days
Treatment emergent ocular and non-ocular adverse events are based on the Safety Set
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | AXR-270 Low Dose | AXR-270 Low Dose administered once daily AXR-270 Low Dose: AXR-270 Topical Eyelid Cream |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Covid | Infections and infestations | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Houman Hemmati | AxeroVision, Inc. | +1 (310) 600-4123 | houman@axerovision.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 3, 2020 | Dec 8, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 27, 2020 | Dec 8, 2022 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D000080343 | Meibomian Gland Dysfunction |
| ID | Term |
|---|---|
| D005141 | Eyelid Diseases |
| D005128 | Eye Diseases |
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| AXR-270 High Dose |
| Drug |
AXR-270 Topical Eyelid Cream |
|
| AXR-270 Vehicle | Drug | AXR-270 Topical Eyelid Cream Vehicle |
|
| 22 Days |
| COMPLETED |
|
| NOT COMPLETED |
|
| BG002 | AXR-270 Vehicle | AXR-270 Vehicle administered once daily AXR-270 Vehicle: AXR-270 Topical Eyelid Cream Vehicle |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Total Meibomian Gland Dysfunction Score | 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). Lower scores indicate a better outcome. Scores: 0 = clear/slightly yellow; 1 = opaque/yellow, whitish, particulate; 2 = paste; 3 = none/occluded. | Mean | Standard Deviation | units on a scale |
|
AXR-270 Vehicle administered once daily
AXR-270 Vehicle: AXR-270 Topical Eyelid Cream Vehicle
|
|
| 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. | Full Analysis Set (Intent-to-Treat) | Posted | Mean | Standard Deviation | score on a scale | 22 Days |
|
|
|
| 0 |
| 42 |
| 0 |
| 42 |
| 1 |
| 42 |
| EG001 | AXR-270 High Dose | AXR-270 High Dose administered once daily AXR-270 High Dose: AXR-270 Topical Eyelid Cream | 0 | 43 | 0 | 43 | 1 | 43 |
| EG002 | AXR-270 Vehicle | AXR-270 Vehicle administered once daily AXR-270 Vehicle: AXR-270 Topical Eyelid Cream Vehicle | 0 | 43 | 0 | 43 | 4 | 43 |
| increased blood creatine phosphokinase | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| mild urinary tract infection | Renal and urinary disorders | Non-systematic Assessment |
|
| mild headache | Nervous system disorders | Non-systematic Assessment |
|
| mild eyelid pruritus | Eye disorders | Non-systematic Assessment |
|
| mild eyelid erythema, edema | Eye disorders | Non-systematic Assessment |
|
Clinical Study Agreement defined what qualifies as Confidential Information and restrictions on publication of study results.