YSBP vs. Lumigan® for Glaucoma or Ocular Hypertension
This study is comparing two eye drop treatments for primary open-angle glaucoma (POAG) or ocular hypertension (OH), which are conditions that can increase pressure inside your eye. Researchers want to see if Bimatoprost ophthalmic solution 0.01% YSBP works as well as Lumigan® (bimatoprost ophthalmic solution 0.01%). You might be able to join if you are 18 or older, have POAG or OH in both eyes, and need treatment for both eyes. The main goal is to measure your eye pressure after 12 weeks to see how effective each treatment is. The current recruitment status is unclear, and the study plans to enroll about 600 people.
- Study design
- This is a randomized, investigator-blind, active-controlled study comparing two treatments. It plans to enroll about 600 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your eye pressure will be measured at Week 12.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT07661329
A Comparative, Randomized, Investigator-blind, Active-controlled, Parallel-group, Multicenter, Clinical Endpoint Study
Recruiting
PHASE3Ages 18+InterventionalTreatmentYS Life Science Co., Ltd.
~600 participants
Updated 2026-06-22 on ClinicalTrials.gov
What's tested:Bimatoprost ophthalmic solution 0.01% YSBPbimatoprost ophthalmic solution 0.01% (Lumigan®)
At a glance
Recruiting sites
1 of 16 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Intra-Ocular Pressure
Measured over Week 12
Conditions
Where it's being run
16 sites across 7 statesCalifornia5
Florida3
Georgia2
Missouri2
Texas2
Kentucky1
New York1
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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:
No history of addiction to any recreational drug or drug dependence or alcohol addiction
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).
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
Exclusion
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.
What this trial measures
- Intra-Ocular PressureWeek 12
the two sided 95% confidence interval (CI) for the treatment difference (test minus reference) in mean IOP of study eye (a continuous variable)