BlepharitisPhase 2VISTA-1NCT06720896
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.
A Phase 2 study testing APT-001 topical ophthalmic ointment (spinosad) in people with Blepharitis, run by Aperta Biosciences, LLC at 2 sites in Guatemala.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Blepharitis
- What is being tested?
- APT-001 topical ophthalmic ointment (spinosad)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 2 sitesGuatemala
- Study dates
- 1 Nov 2025to 30 Sep 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- Use of investigational drug, chronic glaucoma medications, steroid.
- Uncontrolled systemic disease.
- Acute or chronic illness that would confound study results.
Trial locations and contacts
2 sites in 1 country.
Guatemala2 sites
Dr. Rudy Gutierrez Diaz Sede Central
Guatemala City
EyeScan, Imágenes Diagnósticas Oculares, S. A.
Guatemala City
About this study
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.
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.
Read the 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.
- Conditions
- Blepharitis
- Being tested
- APT-001 topical ophthalmic ointment (spinosad), Vehicle control for APT-001 topical ophthalmic ointment
- Keywords
- Blepharitis
- Medical subject headings
- Blepharitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
APT-001 topical ophthalmic ointment (spinosad)Drug
APT-001 topical ophthalmic ointment, administered once daily
Vehicle control for APT-001 topical ophthalmic ointmentDrug
Vehicle control for APT-001 topical ophthalmic ointment, administered once daily
| Study group | Role | What they receive |
|---|---|---|
| Active | Active comparator | APT-001 topical ophthalmic ointment, administered once daily for approximately 43 days Receives: Drug: APT-001 topical ophthalmic ointment (spinosad) |
| Control | Placebo comparator | Vehicle control of APT-001 topical ophthalmic ointment, administered once daily for approximately 43 days Receives: Drug: Vehicle control for APT-001 topical ophthalmic ointment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Collarette Cure
Eyelid collarette count score 0
Measured: From enrollment to the end of treatment at 6 weeks
Secondary outcomes (5)
Overall reduction in combined eyelid collarette and erythema scores
Overall reduction in combined eyelid collarette and erythema scores
Measured: From enrollment to the end of treatment at 6 weeks
Erythema Cure rate
Erythema Cure rate
Measured: From enrollment to the end of treatment at 6 weeks
Combined Cure rate
Combined Cure rate
Measured: From enrollment to the end of treatment at 6 weeks
Demodex mite density
Demodex mite density
Measured: From enrollment to the end of treatment at 6 weeks
Time to a Combined Cure.
Time to a Combined Cure
Measured: From enrollment to the end of treatment at 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2024
- Study start1 Nov 2025
- Primary completion13 Jul 2026
- Study completion30 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BlepharitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aperta Biosciences, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Josue Moran, Ph.D., Study director, Aperta Biosciences, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06720896
- Sponsor's protocol ID
- VISTA-1
- Acronym
- VISTA-1
- Status last verified
- Oct 2026
- First submitted
- 3 Dec 2024
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06720896
- Acronym / sponsor ID
- VISTA-1 / VISTA-1
- Conditions
- Blepharitis
- Keywords
- Blepharitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Aperta Biosciences, LLCIndustry (pharma, biotech, devices)
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- 13 Jul 2026 (actual)
- Study completion
- 30 Sep 2026 (actual)
- First posted
- 6 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active | Active comparator | Drug: APT-001 topical ophthalmic ointment (spinosad)APT-001 topical ophthalmic ointment, administered once daily for approximately 43 days |
| Control | Placebo comparator | Drug: Vehicle control for APT-001 topical ophthalmic ointmentVehicle control of APT-001 topical ophthalmic ointment, administered once daily for approximately 43 days |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| APT-001 topical ophthalmic ointment (spinosad)APT-001 topical ophthalmic ointment, administered once daily | Drug | Active |
| Vehicle control for APT-001 topical ophthalmic ointmentVehicle control for APT-001 topical ophthalmic ointment, administered once daily | Drug | Control |
Primary outcome
Collarette Cure
Time frame: From enrollment to the end of treatment at 6 weeks
Eyelid collarette count score 0
5 secondary outcomes
Overall reduction in combined eyelid collarette and erythema scores
Time frame: From enrollment to the end of treatment at 6 weeks
Erythema Cure rate
Time frame: From enrollment to the end of treatment at 6 weeks
Combined Cure rate
Time frame: From enrollment to the end of treatment at 6 weeks
Demodex mite density
Time frame: From enrollment to the end of treatment at 6 weeks
Time to a Combined Cure.
Time frame: From enrollment to the end of treatment at 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Josue Moran, Ph.D. study director
Aperta Biosciences, LLC
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing APT-001 topical ophthalmic ointment (spinosad) in people with Blepharitis, run by Aperta Biosciences, LLC at 2 sites in Guatemala.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Guatemala. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Collarette Cure (time frame: From enrollment to the end of treatment at 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.