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

16. juni 2026 opdateret af: 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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

600

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • California
      • Beverly Hills, California, Forenede Stater, 90210
        • Ikke rekrutterer endnu
        • National Clinical Trials
        • Kontakt:
        • Ledende efterforsker:
          • James Khodabakhsh, Dr
      • Inglewood, California, Forenede Stater, 90301
        • Ikke rekrutterer endnu
        • United medical research institute
        • Kontakt:
        • Ledende efterforsker:
          • James H Peace, Dr
      • Newport Beach, California, Forenede Stater, 92663
        • Rekruttering
        • Eye research foundation, Inc.
        • Kontakt:
        • Ledende efterforsker:
          • David Wirta, Dr.
      • Newport Beach, California, Forenede Stater, 92663
        • Ikke rekrutterer endnu
        • Visionary Eye Research Institute
        • Kontakt:
        • Ledende efterforsker:
          • Ehsan Sadri, Dr
      • Petaluma, California, Forenede Stater, 94954
        • Ikke rekrutterer endnu
        • North Bay Eye Associates
        • Kontakt:
        • Ledende efterforsker:
          • Jason Bacharach, Dr
    • Florida
      • Boynton Beach, Florida, Forenede Stater, 33437
        • Ikke rekrutterer endnu
        • Advanced Research, LLC
        • Kontakt:
        • Ledende efterforsker:
          • Sirtaz Sibia, Dr
      • Miami Beach, Florida, Forenede Stater, 33140
        • Ikke rekrutterer endnu
        • Quantum clinical trials
        • Kontakt:
        • Ledende efterforsker:
          • Shani Reich, Dr
      • Weston, Florida, Forenede Stater, 33326
        • Ikke rekrutterer endnu
        • Advanced Research, LLC
        • Kontakt:
        • Ledende efterforsker:
          • Aarub Kubal, Dr
    • Georgia
      • Morrow, Georgia, Forenede Stater, 30260
        • Ikke rekrutterer endnu
        • Clayton Eye Clinical Research
        • Kontakt:
        • Ledende efterforsker:
          • Lauren Dubiner, Dr
      • Roswell, Georgia, Forenede Stater, 30076
        • Ikke rekrutterer endnu
        • Coastal Research Associates, LLC
        • Kontakt:
        • Ledende efterforsker:
          • Douglas G Day, Dr
    • Kentucky
      • Louisville, Kentucky, Forenede Stater, 40206
        • Ikke rekrutterer endnu
        • The eye care institute
        • Kontakt:
        • Ledende efterforsker:
          • Brennan P Greene, Dr
    • Missouri
      • St Louis, Missouri, Forenede Stater, 63128
        • Ikke rekrutterer endnu
        • Tekwani vision center
        • Kontakt:
        • Ledende efterforsker:
          • Navin Tekwani, Dr
      • St Louis, Missouri, Forenede Stater, 63131
        • Ikke rekrutterer endnu
        • Ophthalmology associate (Eye care)
        • Kontakt:
        • Ledende efterforsker:
          • Rajan P Malhotra, Dr
    • New York
      • Rochester, New York, Forenede Stater, 14618
        • Ikke rekrutterer endnu
        • Rochester Ophthalmological Group
        • Kontakt:
        • Ledende efterforsker:
          • Paul Hartman, Dr
    • Texas
      • Houston, Texas, Forenede Stater, 77008
        • Ikke rekrutterer endnu
        • Houston Eye Associates
        • Kontakt:
        • Ledende efterforsker:
          • Kevin Y Jong, Dr
      • San Antonio, Texas, Forenede Stater, 78229
        • Ikke rekrutterer endnu
        • R and R eye research
        • Kontakt:
        • Ledende efterforsker:
          • Anhtuan Nguyen, Dr

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Behandling T
Medicin: Bimatoprost ophthalmic solution 0.01% YSBP
YSBP
Aktiv komparator: Treatment R
Medicin: bimatoprost ophthalmic solution 0.01% (Lumigan®)
Lumigan®

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

YS Life Science Co., Ltd.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

2. juni 2026

Primær færdiggørelse (Anslået)

1. november 2027

Studieafslutning (Anslået)

31. december 2027

Datoer for studieregistrering

Først indsendt

16. juni 2026

Først indsendt, der opfyldte QC-kriterier

16. juni 2026

Først opslået (Faktiske)

22. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

22. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

16. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • YSLS001

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Bimatoprost ophthalmic solution 0.01% YSBP

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Sponsor / samarbejdspartnere

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