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

Official title

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).

Overview

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.

Interventions

• Drug Bimatoprost ophthalmic solution 0.01% YSBP
  YSBP
• Drug bimatoprost ophthalmic solution 0.01% (Lumigan®)
  Lumigan®

Primary outcome measures

• Intra-Ocular Pressure [Time frame: Week 12]

Eligibility criteria

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:

• 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.
• Intrauterine device (IUD) or intrauterine system (IUS)
• Double barrier method of contraception (condom and occlusive cap or condom and spermicidal agent)
• Male sterilization (at least 6 months prior to screening, should be the sole male partner for that subject)
• Female sterilization (surgical bilateral oophorectomy) or tubal ligation at least 6 weeks prior to study participation
• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

United States · 16 centers

• National Clinical Trials — Beverly Hills
• United medical research institute — Inglewood
• Eye research foundation, Inc. — Newport Beach
• Visionary Eye Research Institute — Newport Beach
• North Bay Eye Associates — Petaluma
• Advanced research, LLC — Boynton Beach
• Quantum clinical trials — Miami Beach
• Advanced research, LLC — Weston
• … and 8 more centers

Identifiers

NCT: NCT07661329 · YSLS001

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗