A Phase 2, Controlled, Double Blind, Randomized and Multicenter Study to Compare Efficacy and Safety of a Novel Topical Therapy (APT-001, Spinosad 1.8%) in Patients With Blepharitis.
NCT ID: NCT06720896
Last Updated: 2025-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
100 participants
INTERVENTIONAL
2025-11-01
2026-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Active
APT-001 topical ophthalmic ointment, administered once daily for approximately 43 days
APT-001 topical ophthalmic ointment (spinosad)
APT-001 topical ophthalmic ointment, administered once daily
Control
Vehicle control of APT-001 topical ophthalmic ointment, administered once daily for approximately 43 days
Vehicle control for APT-001 topical ophthalmic ointment
Vehicle control for APT-001 topical ophthalmic ointment, administered once daily
Interventions
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APT-001 topical ophthalmic ointment (spinosad)
APT-001 topical ophthalmic ointment, administered once daily
Vehicle control for APT-001 topical ophthalmic ointment
Vehicle control for APT-001 topical ophthalmic ointment, administered once daily
Eligibility Criteria
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Inclusion Criteria
* At least 6 years of age.
* Eyelid collarette count (minimum score 2).
* Willing and able to follow all instructions and attend all study visits.
* Able to avoid prohibited medication for the duration of the study.
* Patients can willingly provide consent or have a legal authorized representative provide consent on the informed consent (IC) Form.
Exclusion Criteria
* Utilizing any current medical therapy for the eye.
* History of allergic reaction to spinosad or any formulation component.
* Patients using eyelid hygiene or other treatment(s) for blepharitis within 14 days of screening.
* History of ocular surgery within the past 1 year.
* Presence of other ocular diseases that may affect study outcomes (Corneal Dystrophies, Salzmanns disease, Severe dry eye, Keratoconus, Glaucoma filtering blebs).
* Use of investigational drug, chronic glaucoma medications, steroid.
* Uncontrolled systemic disease.
* Acute or chronic illness that would confound study results.
6 Years
ALL
No
Sponsors
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Aperta Biosciences, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Josue Moran, Ph.D.
Role: STUDY_DIRECTOR
Aperta Biosciences, LLC
Locations
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Dr. Rudy Gutierrez Diaz Sede Central
Guatemala City, , Guatemala
EyeScan, Imágenes Diagnósticas Oculares, S. A.
Guatemala City, , Guatemala
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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VISTA-1
Identifier Type: -
Identifier Source: org_study_id