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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.

NCT06720896 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-05-19

No results posted yet for this study

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.

Conditions

  • Blepharitis

Interventions

DRUG

APT-001 topical ophthalmic ointment (spinosad)

APT-001 topical ophthalmic ointment, administered once daily

DRUG

Vehicle control for APT-001 topical ophthalmic ointment

Vehicle control for APT-001 topical ophthalmic ointment, administered once daily

Sponsors & Collaborators

  • Aperta Biosciences, LLC

    lead INDUSTRY

Principal Investigators

  • Josue Moran, Ph.D. · Aperta Biosciences, LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-01
Primary Completion
2026-06-30
Completion
2026-06-30

Countries

  • Guatemala

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06720896 on ClinicalTrials.gov