Clinical trial NCT06720896: 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.
Official title: 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.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Blepharitis
Keywords: Blepharitis
Lead sponsor: Aperta Biosciences, LLC
Sponsor class: INDUSTRY
First posted: 2024-12-06
Enrollment: 100
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: Collarette Cure
timeFrame: From enrollment to the end of treatment at 6 weeks
Secondary outcomes:
measure: Overall reduction in combined eyelid collarette and erythema scores
timeFrame: From enrollment to the end of treatment at 6 weeks
measure: Erythema Cure rate
timeFrame: From enrollment to the end of treatment at 6 weeks
measure: Combined Cure rate
timeFrame: From enrollment to the end of treatment at 6 weeks
measure: Demodex mite density
timeFrame: From enrollment to the end of treatment at 6 weeks
measure: Time to a Combined Cure.
timeFrame: From enrollment to the end of treatment at 6 weeks
Other outcomes:
Locations:
city: Guatemala City
country: Guatemala
facility: Dr. Rudy Gutierrez Diaz Sede Central
Study officials:
affiliation: Aperta Biosciences, LLC
name: Josue Moran, Ph.D.
role: STUDY_DIRECTOR
References: