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.
Vision and Inflammation Study Testing Anti-acarid Therapeutics (VISTA-1): 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.
Aperta Biosciences, LLC
100 participants
Nov 1, 2025
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria6
- Symptomatic blepharitis.
- 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 Criteria9
- Women with confirmed pregnancies.
- 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.
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Interventions
APT-001 topical ophthalmic ointment, administered once daily
Vehicle control for APT-001 topical ophthalmic ointment, administered once daily
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06720896