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A Comparative, Randomized, Investigator-blind, Active-controlled, Parallel-group, Multicenter, Clinical Endpoint Study

16. juni 2026 oppdatert av: YS Life Science Co., Ltd.

A Comparative Randomized, Investigator-Blind, Active-Controlled, Parallel-Group, Multicenter, Clinical Endpoint Study to Evaluate Efficacy and Safety of Bimatoprost Ophthalmic Solution 0.01% (YSBP) of YS Life Science Co., Ltd. (YSLS) and Lumigan® (Bimatoprost Ophthalmic Solution) 0.01% of AbbVie INC, in the Treatment of Subjects With Primary Open-Angle Glaucoma (POAG) or Ocular Hypertension (OH).

This study is to establish non-inferiority of a preservative free formulation of Bimatoprost ophthalmic solution 0.01% (YSBP) of YS Life Science Co., Ltd. compared to LUMIGAN® (bimatoprost ophthalmic solution) 0.01% of AbbVie INC in subjects with primary open angle glaucoma (POAG) or ocular hypertension.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

600

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • California
      • Beverly Hills, California, Forente stater, 90210
        • Har ikke rekruttert ennå
        • National Clinical Trials
        • Ta kontakt med:
        • Hovedetterforsker:
          • James Khodabakhsh, Dr
      • Inglewood, California, Forente stater, 90301
        • Har ikke rekruttert ennå
        • United Medical Research Institute
        • Ta kontakt med:
        • Hovedetterforsker:
          • James H Peace, Dr
      • Newport Beach, California, Forente stater, 92663
        • Rekruttering
        • Eye Research Foundation, Inc.
        • Ta kontakt med:
        • Hovedetterforsker:
          • David Wirta, Dr.
      • Newport Beach, California, Forente stater, 92663
        • Har ikke rekruttert ennå
        • Visionary Eye Research Institute
        • Ta kontakt med:
        • Hovedetterforsker:
          • Ehsan Sadri, Dr
      • Petaluma, California, Forente stater, 94954
        • Har ikke rekruttert ennå
        • North Bay Eye Associates
        • Ta kontakt med:
        • Hovedetterforsker:
          • Jason Bacharach, Dr
    • Florida
      • Boynton Beach, Florida, Forente stater, 33437
        • Har ikke rekruttert ennå
        • Advanced Research, LLC
        • Ta kontakt med:
        • Hovedetterforsker:
          • Sirtaz Sibia, Dr
      • Miami Beach, Florida, Forente stater, 33140
        • Har ikke rekruttert ennå
        • Quantum Clinical Trials
        • Ta kontakt med:
        • Hovedetterforsker:
          • Shani Reich, Dr
      • Weston, Florida, Forente stater, 33326
        • Har ikke rekruttert ennå
        • Advanced Research, LLC
        • Ta kontakt med:
        • Hovedetterforsker:
          • Aarub Kubal, Dr
    • Georgia
      • Morrow, Georgia, Forente stater, 30260
        • Har ikke rekruttert ennå
        • Clayton Eye Clinical Research
        • Ta kontakt med:
        • Hovedetterforsker:
          • Lauren Dubiner, Dr
      • Roswell, Georgia, Forente stater, 30076
        • Har ikke rekruttert ennå
        • Coastal Research Associates, LLC
        • Ta kontakt med:
        • Hovedetterforsker:
          • Douglas G Day, Dr
    • Kentucky
      • Louisville, Kentucky, Forente stater, 40206
        • Har ikke rekruttert ennå
        • The Eye Care Institute
        • Ta kontakt med:
        • Hovedetterforsker:
          • Brennan P Greene, Dr
    • Missouri
      • St Louis, Missouri, Forente stater, 63128
        • Har ikke rekruttert ennå
        • Tekwani Vision Center
        • Ta kontakt med:
        • Hovedetterforsker:
          • Navin Tekwani, Dr
      • St Louis, Missouri, Forente stater, 63131
        • Har ikke rekruttert ennå
        • Ophthalmology associate (Eye care)
        • Ta kontakt med:
        • Hovedetterforsker:
          • Rajan P Malhotra, Dr
    • New York
      • Rochester, New York, Forente stater, 14618
        • Har ikke rekruttert ennå
        • Rochester Ophthalmological Group
        • Ta kontakt med:
        • Hovedetterforsker:
          • Paul Hartman, Dr
    • Texas
      • Houston, Texas, Forente stater, 77008
        • Har ikke rekruttert ennå
        • Houston Eye Associates
        • Ta kontakt med:
        • Hovedetterforsker:
          • Kevin Y Jong, Dr
      • San Antonio, Texas, Forente stater, 78229
        • Har ikke rekruttert ennå
        • R and R eye research
        • Ta kontakt med:
        • Hovedetterforsker:
          • Anhtuan Nguyen, Dr

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

Inclusion Criteria:

  • Subjects willing and able to provide voluntary informed consent and to follow protocol requirements.
  • Male or females aged ≥18 years.
  • Subjects with primary open-angle glaucoma (POAG) or ocular hypertension (OH) in both eyes
  • Subjects requiring treatment in both the eyes and able to discontinue the use of all ocular hypotensive medication(s) or switch ocular hypotensive medications and undergo appropriate washout period.
  • Adequate washout period prior to baseline (Day 0) of any ocular hypotensive medications
  • Baseline (Day 0/hour 0) IOP ≥22 mm Hg and ≤ 34 mm Hg in both eyes, with difference between the IOP in left and right eyes not being more than 5 mm Hg
  • Subjects' IOP is likely to be controlled with monotherapy.
  • Baseline best corrected visual acuity equivalent to Snellen acuity of 20/100 or better in each eye, using a logarithmic visual acuity chart.

  • Women of childbearing potential (defined as women physiologically capable of becoming pregnant unless they are using an effective method of contraception during the study participation) practicing any of the following acceptable methods of contraception:

    1. Oral or parenteral (injection, patch, or implant) hormonal contraception which has been continuously used for at least 1 month prior to first dose of study medication.
    2. Intrauterine device (IUD) or intrauterine system (IUS)
    3. Double barrier method of contraception (condom and occlusive cap or condom and spermicidal agent)
    4. Male sterilization (at least 6 months prior to screening, should be the sole male partner for that subject)
    5. Female sterilization (surgical bilateral oophorectomy) or tubal ligation at least 6 weeks prior to study participation
    6. Total abstinence; partial abstinence is not acceptable
  • No history of addiction to any recreational drug or drug dependence or alcohol addiction

Exclusion Criteria:

  • Female subjects with positive pregnancy test or lactating or planning a pregnancy.
  • Contraindication or known hypersensitivity to Bimatoprost, related class of drugs, or any of the excipients of formulation or benzalkonium chloride.
  • Current or history of severe hepatic or renal impairment.
  • Current or history within 3 months prior to baseline of any other significant ocular disease, e.g., corneal edema, uveitis, ocular infection, or ocular trauma in either eye (Note: stable myopia, strabismus, and cataracts will be allowed provided that the other inclusion/exclusion criteria are met).
  • Current corneal abnormalities that would prevent accurate IOP readings with tonometer.
  • Functionally significant visual field loss as determined by perimetry.
  • Subjects with corneal grafts.
  • Subject has contraindication to pupil dilation.
  • Use at any time prior to baseline of an intraocular corticosteroid implant.
  • Use of contact lens within 1 week prior to baseline.
  • Use within 21 days prior to baseline of 1) a topical ophthalmic corticosteroid or 2) a topical corticosteroid.
  • Use within 21 days prior to baseline of a systemic corticosteroid.
  • Use within 6 months prior to baseline of intravitreal or subtenon injection of an ophthalmic corticosteroid.
  • Underwent within 3 months prior to baseline any other intraocular surgery (e.g., cataract surgery).

Underwent any filtering surgery, or laser surgery for IOP reduction (e.g., laser trabeculoplasty) within 3 months prior to baseline or refractive surgery at any time.

  • Subjects with a history of non-responder to bimatoprost monotherapy.
  • Significant ocular surface findings (e.g., hyperemia or irritation, mild or greater) in either eye found on gross macroscopic or slit lamp examination.
  • Severe glaucoma with a cup/disk ratio greater than 0.8 (not including physiological cupping in the Investigators' opinion).
  • Chronic use of any systemic medication that may affect IOP with less than 2 months stable dosing regimen (i.e., sympathomimetic agents, betaadrenergic blocking agents, alpha-agonists, alpha-adrenergic blocking agents, calcium channel blockers, angiotensin-converting enzyme inhibitors, etc.)
  • Central Corneal thickness (CCT) <480 microns or >620 microns for study eye.
  • Known history or presence of any uncontrolled systemic disease
  • History of recurrent ocular seasonal allergies within past 2 years prior to screening.
  • Any other medical condition or serious intercurrent illness that, in the Investigator's opinion, may make it undesirable for the subject to participate in the study and would limit adherence to the study requirements.
  • Participation in any clinical study within 30 days before the first dose of the study drug.
  • Subjects with known cases of active Hepatitis B virus (HBV), Hepatitis C Virus (HCV) or Human Immunodeficiency Virus (HIV) infection.
  • Subjects with aphakia or history of herpes simplex keratitis

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Behandling T
Legemiddel: Bimatoprost ophthalmic solution 0.01% YSBP
YSBP
Aktiv komparator: Treatment R
Legemiddel: bimatoprost ophthalmic solution 0.01% (Lumigan®)
Lumigan®

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Intra-Ocular Pressure
Tidsramme: Week 12
the two sided 95% confidence interval (CI) for the treatment difference (test minus reference) in mean IOP of study eye (a continuous variable)
Week 12

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

YS Life Science Co., Ltd.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

2. juni 2026

Primær fullføring (Antatt)

1. november 2027

Studiet fullført (Antatt)

31. desember 2027

Datoer for studieregistrering

Først innsendt

16. juni 2026

Først innsendt som oppfylte QC-kriteriene

16. juni 2026

Først lagt ut (Faktiske)

22. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

22. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

16. juni 2026

Sist bekreftet

1. juni 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • YSLS001

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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