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.
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
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
Show all 16Show fewer
- 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.
Show all 26Show fewer
- 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.
22 sites in 2 countries
United States14 sites, 14 recruiting
- Not yet 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
- Recruiting
Eye research foundation, Inc.
Newport Beach, California, 92663
Linda Wirta, 949-650-1863, linda.wirta@drwirta.com
David Wirta, Dr.
- Not yet 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
India8 sites, 8 recruiting
- Not yet 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.
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).
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.
- 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 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.
- 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)
Sponsor and investigators
- Lead sponsor
- YS Life Science Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
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