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.
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 6
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
Guatemala
Dr. Rudy Gutierrez Diaz Sede Central
RECRUITING
Guatemala City
EyeScan, Imágenes Diagnósticas Oculares, S. A.
RECRUITING
Guatemala City
Contact Information
Primary
Josue Moran, Ph.D.
vista@apertabio.com
512-270-3960
Time Frame
Start Date: 2025-11-01
Estimated Completion Date: 2026-04
Participants
Target number of participants: 100
Treatments
Active_comparator: Active
APT-001 topical ophthalmic ointment, administered once daily for approximately 43 days
Placebo_comparator: Control
Vehicle control of APT-001 topical ophthalmic ointment, administered once daily for approximately 43 days
Related Therapeutic Areas
Sponsors
Leads: Aperta Biosciences, LLC