Primary Open Angle Glaucoma (POAG)Phase 3NCT07661329

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

A Phase 3 study testing Bimatoprost ophthalmic solution 0.01% YSBP and bimatoprost ophthalmic solution 0.01% (Lumigan®) in people with Primary Open Angle Glaucoma (POAG) and Ocular Hypertension (OH), run by YS Life Science Co., Ltd. at 22 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

Search all trials

Trial summary

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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Primary Open Angle Glaucoma (POAG), Ocular Hypertension (OH)
What is being tested?: Bimatoprost ophthalmic solution 0.01% YSBP and bimatoprost ophthalmic solution 0.01% (Lumigan®)
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 600 participants
Where: 22 sitesin 2 countries
Study dates: 2 Jun 2026to 31 Dec 2027
Phase: Phase 3
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

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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

Who cannot join

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.

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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

Trial locations and contacts

22 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Country

City, postcode or hospital

Sites recruiting now only

22 sites in 2 countries

United States14 sites, 14 recruiting

National Clinical Trials
Beverly Hills, California, 90210
James Khodabakhsh, Dr., 888-407-9881, Jkhodabakhsh@nationalclinicaltrials.com
James Khodabakhsh, Dr
Not yet recruiting
Advanced research, LLC
Boynton Beach, Florida, 33437
Julia Conceicao, 954-302-3163, jconceicao@advancedresearchfl.com
Sirtaz Sibia, Dr
Not yet recruiting
Houston Eye Associates
Houston, Texas, 77008
Bhavna Shah, Dr, (832)-553-7113, bshah@HoustonEye.com
Kevin Y Jong, Dr
Not yet recruiting
United medical research institute
Inglewood, California, 90301
Carmen Caballero-Marin, 888-636-1062, carmen@drjamespeace.com
James H Peace, Dr
Not yet recruiting
The eye care institute
Louisville, Kentucky, 40206
Daniela Castellanos, 513-305-8654, danielleurbansky@eyecare-partners.com
Brennan P Greene, Dr
Not yet recruiting
Clayton Eye Clinical Research
Morrow, Georgia, 30260
Jahanzeb Khan, 770-968-8888, HelenDuBiner@claytoneye.net
Lauren Dubiner, Dr
Not yet recruiting
Eye research foundation, Inc.
Newport Beach, California, 92663
Linda Wirta, 949-650-1863, linda.wirta@drwirta.com
David Wirta, Dr.
Recruiting
Visionary Eye Research Institute
Newport Beach, California, 92663
Melanie, 9494276099, m.martinez@visionaryeyeinstitute.com
Ehsan Sadri, Dr
Not yet recruiting
North Bay Eye Associates
Petaluma, California, 94954
Dominiga Ferreyra, 707-769-2237, dferreyra@northbayeye.com
Jason Bacharach, Dr
Not yet recruiting
Coastal Research Associates, LLC
Roswell, Georgia, 30076
John schcur, 770-968-8888, john@coastalresearchassociates.com
Douglas G Day, Dr
Not yet recruiting
R and R eye research
San Antonio, Texas, 78229
Maggie Hazen, 210-424-2584, maggie@eye-assoc.com
Anhtuan Nguyen, Dr
Not yet recruiting
Tekwani vision center
St Louis, Missouri, 63128
Lisa Dinsmore, (314) 842-2020, dinsmore.tvc@gmail.com
Navin Tekwani, Dr
Not yet recruiting
Ophthalmology associate (Eye care)
St Louis, Missouri, 63131
Danielle M Urbansky, 314-966-3377, danielleurbansky@eyecare-partners.com
Rajan P Malhotra, Dr
Not yet recruiting
Advanced research, LLC
Weston, Florida, 33326
Jillene Moxam, 954-302-3047, jmoxam@advancedresearchfl.com
Aarub Kubal, Dr
Not yet recruiting

Other trials in United States

India8 sites, 8 recruiting

Jyoti eye hospital
Ahmedabad, Gujarat, 380013
Mehul Dhudashia, +91-9727450700, mehuldmd.rch@gmail.com
Bhavik Zala, Dr.
Not yet recruiting
M&J western regional institute of ophthalmology
Ahmedabad, Gujarat, 380016
Chintan Sheth, +91-8401070317, chintan.sheth@skycrapercrs.in
Purvi Bhagat, Dr.
Not yet recruiting
GMERS medical college and civil hospital sola
Ahmedabad, Gujarat, 380060
Indrajeet Kumar, +91-9327158866, ikumarcr@gmail.com
Deepika Singhal, Dr.
Not yet recruiting
Netralaya super speciality eye care hospital
Ahmedabad, Gurajat, 380006
Mehul Dhudashia, +91-9727450700, mehuldmd.rch@gmail.com
Kushal Delhiwala, Dr.
Not yet recruiting
LV Prasad eye institute
Bhubaneswar, Odisha, 751024
Asit Behera, +91-9090517730, asit.behera@lvpei.org
Avik Kumar Roy, Dr.
Not yet recruiting
Regional institute of ophthalmology
Kolkata, West Bengal, 700073
Sabyassachi Banerjee, +91-8450822542, sabyasachi@infoclinconsultancy.com
Khandkar Fariduddin, Dr.
Not yet recruiting
Ambade eye hospital
Nagpur, Maharashtra, 440017
Nitin Dayani, +91-9373295955, pcr.nitindayani@gmail.com
Ajay Ambade, Dr.
Not yet recruiting
Dr. D. Y. Patil medical college hospital & research centre
Nerul, Mumbai, 400706
Mehul Shah, +91-9323009989, mehul1400@gmail.com
Sumita Dahiya, Dr.
Not yet recruiting

Other trials in India

About this 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).

Conditions: Primary Open Angle Glaucoma (POAG), Ocular Hypertension (OH)
Being tested: Bimatoprost ophthalmic solution 0.01% YSBP, bimatoprost ophthalmic solution 0.01% (Lumigan®)
Medical subject headings: Glaucoma, Open-Angle, Ocular Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT07661329
Study group	Role	What they receive
YSBP	Experimental	Not described Receives: Drug: Bimatoprost ophthalmic solution 0.01% YSBP
Lumigan	Active comparator	Not described Receives: Drug: bimatoprost ophthalmic solution 0.01% (Lumigan®)

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Jun 202631 Dec 2027

First posted22 Jun 2026
Study start2 Jun 2026
Primary completion1 Nov 2027 (estimated)
Study completion31 Dec 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Primary Open Angle Glaucoma (POAG)Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Investigator, Outcomes assessor
Enrolment: 600 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07661329
Sponsor's protocol ID: YSLS001
Status last verified: Sep 2026
First submitted: 16 Jun 2026
Last updated: 23 Sep 2026
Results posted: No
FDA-regulated drug: Yes
FDA-regulated device: No

Interested in taking part?

Each site lists its own contact. Pick the site nearest to you.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

RecruitingPhase 2
A Phase 2a Study Comparing the Efficacy, Safety and Tolerability of Pregabalin Eye Drops Comparing With Timolol Eye Drops in Adults With Glaucoma or High Eye Pressure.
Primary Open - Angle Glaucoma (POAG), Ocular Hypertension (OHT)
Recruiting
The Acute Effect of Exercise Type And Timing on Ambulatory Blood Pressure and Intra-Ocular Pressure in Individuals With Glaucoma (The ACHIEVE-project).
Glaucoma Open-Angle Primary, Hypertension
RecruitingObservational study
PRESERFLO™ MicroShunt XI Observational PMCF Study With no Control Group
Primary Open Angle Glaucoma
Active, not recruitingObservational study
Glaucoma, Visual Field Loss, and Their Association With Life Space in Older Adults
Primary Open Angle Glaucoma
Active, not recruitingObservational study
Impact of Glaucoma and Visual Field Loss on Life Space
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All Primary Open Angle Glaucoma (POAG) trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

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).
ClinicalTrials.gov ID: NCT07661329
Acronym / sponsor ID: YSLS001
Conditions: Primary Open Angle Glaucoma (POAG), Ocular Hypertension (OH)
Phase: Phase 3
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 600 participants (estimated)
Lead sponsor: YS Life Science Co., Ltd.Industry (pharma, biotech, devices)
Study start: 2 Jun 2026 (actual)
Primary completion: 1 Nov 2027 (estimated)
Study completion: 31 Dec 2027 (estimated)
First posted: 22 Jun 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
YSBP	Experimental	Drug: Bimatoprost ophthalmic solution 0.01% YSBP
Lumigan	Active comparator	Drug: bimatoprost ophthalmic solution 0.01% (Lumigan®)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (16 listed)

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

Key exclusion criteria (26 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Bimatoprost ophthalmic solution 0.01% YSBPYSBP	Drug	YSBP
bimatoprost ophthalmic solution 0.01% (Lumigan®)Lumigan®	Drug	Lumigan

Primary outcome

Intra-Ocular Pressure
Time frame: 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)

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.

Related trials for Primary Open Angle Glaucoma (POAG)

RecruitingPhase 2
A Phase 2a Study Comparing the Efficacy, Safety and Tolerability of Pregabalin Eye Drops Comparing With Timolol Eye Drops in Adults With Glaucoma or High Eye Pressure.
Primary Open - Angle Glaucoma (POAG), Ocular Hypertension (OHT)
Recruiting
The Acute Effect of Exercise Type And Timing on Ambulatory Blood Pressure and Intra-Ocular Pressure in Individuals With Glaucoma (The ACHIEVE-project).
Glaucoma Open-Angle Primary, Hypertension
RecruitingObservational study
PRESERFLO™ MicroShunt XI Observational PMCF Study With no Control Group
Primary Open Angle Glaucoma
Active, not recruitingObservational study
Glaucoma, Visual Field Loss, and Their Association With Life Space in Older Adults
Primary Open Angle Glaucoma
Active, not recruitingObservational study
Impact of Glaucoma and Visual Field Loss on Life Space
Primary Open-angle Glaucoma

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

National Clinical Trials

Beverly Hills, United States

888-407-9881

Jkhodabakhsh@nationalclinicaltrials.com

United medical research institute

Inglewood, United States

888-636-1062

carmen@drjamespeace.com

Eye research foundation, Inc.

Newport Beach, United States

949-650-1863

linda.wirta@drwirta.com

22 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 22 sites in United States, India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Intra-Ocular Pressure (time frame: Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07661329.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026.