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The purpose of this study is to establish the clinical efficacy of APT-001 topical therapy 1.8% in patients with blepharitis as compared to its vehicle control, and to establish that the therapeutic is safe and generally well tolerated by patients.
This Phase 2 study is a randomized, controlled, double-blind trial to compare the safety and efficacy of APT-001 1.8% to vehicle control for the treatment of blepharitis. The primary objective of the study is to compare the safety and efficacy of APT-001 compared to its vehicle from Day 1 to Day 43 in patients with blepharitis. The primary efficacy endpoint will be cure based upon collarettes. Safety will be determined by assessing adverse effects related to the treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active | Active Comparator | APT-001 topical ophthalmic ointment, administered once daily for approximately 43 days |
|
| Control | Placebo Comparator | Vehicle control of APT-001 topical ophthalmic ointment, administered once daily for approximately 43 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| APT-001 topical ophthalmic ointment (spinosad) | Drug | APT-001 topical ophthalmic ointment, administered once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Collarette Cure | Eyelid collarette count score 0 | From enrollment to the end of treatment at 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Overall reduction in combined eyelid collarette and erythema scores | Overall reduction in combined eyelid collarette and erythema scores | From enrollment to the end of treatment at 6 weeks |
| Erythema Cure rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Josue Moran, Ph.D. | Aperta Biosciences, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr. Rudy Gutierrez Diaz Sede Central | Guatemala City | Guatemala | ||||
| EyeScan, Imágenes Diagnósticas Oculares, S. A. |
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| Vehicle control for APT-001 topical ophthalmic ointment | Drug | Vehicle control for APT-001 topical ophthalmic ointment, administered once daily |
|
Erythema Cure rate
| From enrollment to the end of treatment at 6 weeks |
| Combined Cure rate | Combined Cure rate | From enrollment to the end of treatment at 6 weeks |
| Demodex mite density | Demodex mite density | From enrollment to the end of treatment at 6 weeks |
| Time to a Combined Cure. | Time to a Combined Cure | From enrollment to the end of treatment at 6 weeks |
| Guatemala City |
| Guatemala |
| ID | Term |
|---|---|
| D001762 | Blepharitis |
| ID | Term |
|---|---|
| D005141 | Eyelid Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| C415329 | spinosad |
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