A Phase 2 interventional study of APT-001 topical ophthalmic ointment (spinosad) and Vehicle control for APT-001 topical ophthalmic ointment in Blepharitis, sponsored by Aperta Biosciences, LLC. Completed at 2 sites in Guatemala. Open to participants aged 6 Years and older. Per ClinicalTrials.gov, last updated 2026-10-27.
Sponsored by Aperta Biosciences, LLC · Phase 2, Interventional, and Treatment
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.
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.
73 studies on the registry are indexed under Blepharitis; 9 are open to participants now.
This study's enrollment of 66 is close to the median of 60 across 65 interventional studies indexed under Blepharitis.
Browse Blepharitis studies →Aperta Biosciences, LLC is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
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A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
APT-001 topical ophthalmic ointment, administered once daily for approximately 43 days
Drug: APT-001 topical ophthalmic ointment (spinosad)
Vehicle control of APT-001 topical ophthalmic ointment, administered once daily for approximately 43 days
Drug: Vehicle control for APT-001 topical ophthalmic ointment
APT-001 topical ophthalmic ointment, administered once daily
Vehicle control for APT-001 topical ophthalmic ointment, administered once daily
Collarette Cure
Eyelid collarette count score 0
Time frame: From enrollment to the end of treatment at 6 weeks
Overall reduction in combined eyelid collarette and erythema scores
Overall reduction in combined eyelid collarette and erythema scores
Time frame: From enrollment to the end of treatment at 6 weeks
Erythema Cure rate
Erythema Cure rate
Time frame: From enrollment to the end of treatment at 6 weeks
Combined Cure rate
Combined Cure rate
Time frame: From enrollment to the end of treatment at 6 weeks
Demodex mite density
Demodex mite density
Time frame: From enrollment to the end of treatment at 6 weeks
Time to a Combined Cure.
Time to a Combined Cure
Time frame: From enrollment to the end of treatment at 6 weeks
Plan to share: No
No publications or documents are linked to this record.
Ran from Nov 2025 to primary completion in Jul 2026, 8 months.
Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 27, 2026: primary completion Jun 2026 → Jul 2026 and completion Jun 2026 → Sep 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Spinosad
Aperta Biosciences, LLC