A Phase 2, Controlled, Double Blind, Randomized and Multicenter Study to Compare Efficacy and Saf… (NCT06720896) | Clinical Trial Compass
RecruitingPhase 2
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.
Guatemala100 participantsStarted 2025-11-01
Plain-language 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.
Who can participate
Age range6 Years
SexALL
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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.
What they're measuring
1
Collarette Cure
Timeframe: From enrollment to the end of treatment at 6 weeks