A Phase 2 Study to Compare Efficacy and Safety of a Novel Topical Therapy (APT-001, Spinosad 1.8%) in Patients With Blepharitis (VISTA-1X)
Vision and Inflammation Study Testing Anti-acarid Therapeutics (VISTA-1X): A Phase 2, Open-Label, Placebo-Controlled, Multicenter Study to Compare Efficacy and Safety of a Novel Topical Therapy (APT-001, Spinosad 1.8%) in Adults 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 placebo, and to establish that the therapeutic is safe and generally well tolerated by patients.
Studieoversikt
Status
Forhold
Detaljert beskrivelse
This Phase 2 study is an open-label trial to compare the safety and efficacy of APT-001 1.8% to placebo control for the treatment of blepharitis. The primary objective of the study is to compare the safety and efficacy of APT-001 compared to placebo from Day 1 to Day 15 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.
Studietype
Registrering (Antatt)
Fase
- Fase 2
Kontakter og plasseringer
Studiekontakt
- Navn: Josue Moran, Ph. D.
- Telefonnummer: 512-270-3960
- E-post: vista@apertabio.com
Studiesteder
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Guatemala City, Guatemala
- EyeScan, Imágenes Diagnósticas Oculares, S. A.
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Ta kontakt med:
- Glendy Martinez
- Telefonnummer: +502 5930-5051
- E-post: Eyescangt@gmail.com
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Hovedetterforsker:
- Rudy Oliver Gutierrez Paz, MD
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Guatemala City, Guatemala
- Hospital de Día, Clínica de Ojos Doctor Gutiérrez
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Ta kontakt med:
- Ozen Martinez
- Telefonnummer: +502-2236-4100
- E-post: servicioalcliente@clinicasdrgutierrez.com
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Hovedetterforsker:
- Rudy Gutierrez Diaz, MD
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Symptomatic blepharitis
- At least 18 years of age
- Eyelid collarette score of at least 2
- Demodex mite density of at least 1.5 mites per lash or higher
- Willing and able to follow all instructions and attend all study visit
- Able to avoid prohibited medication for the duration of the study
- Patients can willingly provide consent on the informed consent form
Exclusion Criteria:
- Women with confirmed pregnancies
- Utilizing any medical or surgical therapy for acute or subacute conditions of 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 3 months
- Presence of other ocular diseases that may affect study outcomes
- Use of investigational drug, chronic glaucoma medications, or steroids
- Uncontrolled systemic disease
- Acute or chronic illness that would confound study results
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Aktiv komparator: Active
APT-001 topical ophthalmic ointment, administered once |
APT-001 topical ophthalmic ointment (spinosad), administered once |
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Placebo komparator: Placebo control for APT-001 topical ophthalmic ointment, administered once
|
Placebo control for APT-001 topical ophthalmic ointment, administered once |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Demodex mite killing
Tidsramme: From enrollment to last visit at 2 weeks
|
Number of living Demodex mites following treatment |
From enrollment to last visit at 2 weeks
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Rate of Collarette Cure
Tidsramme: From enrollment to last visit at 2 weeks
|
Eyelid collarette score 0 |
From enrollment to last visit at 2 weeks
|
|
Rate of Erythema Cure
Tidsramme: From enrollment to last visit at 2 weeks
|
Erythema Cure Rate |
From enrollment to last visit at 2 weeks
|
|
Average Demodex mite density
Tidsramme: From enrollment to last visit at 2 weeks
|
Demodex mite density |
From enrollment to last visit at 2 weeks
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Studieleder: Josue Moran, Ph.D., Aperta Biosciences, LLC
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- VISTA-1X
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
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