RecruitingPhase 3

A Study to Evaluate Efficacy and Safety of YSBP Compared to Lumigan in Patients With Glaucoma or Ocular Hypertension

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).

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study compares YSBP, a preservative-free bimatoprost eye drop, with Lumigan for safety and to see if it works at least as well. It is for adults with primary open-angle glaucoma, a disease that can damage the eye’s nerve, or high eye pressure in both eyes.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 18 or older, willing to give consent and follow study rules.
  • Have primary open-angle glaucoma or high eye pressure in both eyes, with both eyes needing treatment.
  • Able to stop or switch current eye-pressure medicines and wait the required time before the study starts.
  • Starting eye pressure is 22–34 mm Hg in each eye, with no more than a 5 mm Hg difference between eyes.
  • Eye pressure is likely to be controlled with one medicine.
  • Vision with glasses or contacts is 20/100 or better in each eye.
  • If able to become pregnant, use a birth control method allowed by the study or avoid sex completely.
  • No history of drug dependence or addiction to recreational drugs or alcohol.

Who can't join

  • Pregnant, breastfeeding, or planning pregnancy; or unable to safely use bimatoprost, related drugs, or ingredients in the drops because of an allergy or another medical reason.
  • Severe liver or kidney problems now or in the past; uncontrolled disease; active hepatitis B, hepatitis C, or HIV; or another illness that could make participation unsafe or difficult.
  • Certain eye problems, including recent serious eye disease or injury, severe glaucoma, major loss of side vision, eye-surface redness or irritation, or repeated seasonal eye allergies in the past 2 years.
  • A corneal transplant, a missing natural eye lens, past herpes infection of the cornea, or inability to safely have pupils widened. The cornea is the clear front of the eye.
  • Cornea problems that prevent accurate pressure checks, or corneal thickness below 480 or above 620 microns in the study eye.
  • A steroid implant inside the eye at any time; steroid shots in or around the eye within 6 months; steroid eye drops, skin treatments, or whole-body medicines within 21 days; or contact lens use within 1 week before the study starts.
  • Eye surgery or pressure-lowering laser surgery within 3 months before the study starts, or vision-correction surgery at any time.
  • Bimatoprost alone did not work before; regular medicines that affect eye pressure have not had a stable dose for at least 2 months; or participation in another clinical study within 30 days before the first study dose.

Simplified for readability. The official criteria below are what the study team uses.

Official 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: 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

Study sites (14)

CA

FL

GA

KY

MO

TX