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

Part of paid clinical trials in Beverly Hills, California.

Sponsor
YS Life Science Co., Ltd.
Study ID
NCT07661329
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

  • Ocular Hypertension (OH)
  • Primary Open Angle Glaucoma (POAG)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Jun 2, 2026
Status verified
Jun 2026
Primary completion
Nov 1, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
600 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment T
  • Active Comparator: Treatment R

Primary Outcome Measure

Intra-Ocular Pressure [ Time Frame: Week 12 ]

Locations (16)

FacilityCityStateZIPSite coordinators
National Clinical TrialsBeverly HillsCalifornia90210
Shilo Rowlette
[email protected]
702-720-7323
James Khodabakhsh, Dr (PRINCIPAL_INVESTIGATOR)
United medical research instituteInglewoodCalifornia90301
Carmen Caballero-Marin
[email protected]
888-636-1062
James H Peace, Dr (PRINCIPAL_INVESTIGATOR)
Eye research foundation, Inc.Newport BeachCalifornia92663
Linda Wirta
[email protected]
949-650-1863
David Wirta, Dr. (PRINCIPAL_INVESTIGATOR)
Visionary Eye Research InstituteNewport BeachCalifornia92663
Melanie
[email protected]
9494276099
Ehsan Sadri, Dr (PRINCIPAL_INVESTIGATOR)
North Bay Eye AssociatesPetalumaCalifornia94954
Dominiga Ferreyra
[email protected]
707-769-2237
Jason Bacharach, Dr (PRINCIPAL_INVESTIGATOR)
Advanced research, LLCBoynton BeachFlorida33437
Julia Conceicao
[email protected]
954-302-3163
Sirtaz Sibia, Dr (PRINCIPAL_INVESTIGATOR)
Quantum clinical trialsMiami BeachFlorida33140
Kiara Rugba
[email protected]
786-774-1008
Shani Reich, Dr (PRINCIPAL_INVESTIGATOR)
Advanced research, LLCWestonFlorida33326
Jillene Moxam
[email protected]
954-302-3047
Aarub Kubal, Dr (PRINCIPAL_INVESTIGATOR)
Clayton Eye Clinical ResearchMorrowGeorgia30260
Jahanzeb Khan
[email protected]
770-968-8888
Lauren Dubiner, Dr (PRINCIPAL_INVESTIGATOR)
Coastal Research Associates, LLCRoswellGeorgia30076
John schcur
[email protected]
770-968-8888
Douglas G Day, Dr (PRINCIPAL_INVESTIGATOR)
The eye care instituteLouisvilleKentucky40206
Daniela Castellanos
[email protected]
513-305-8654
Brennan P Greene, Dr (PRINCIPAL_INVESTIGATOR)
Ophthalmology associate (Eye care)St LouisMissouri63131
Danielle M Urbansky
[email protected]
314-966-3377
Rajan P Malhotra, Dr (PRINCIPAL_INVESTIGATOR)
Tekwani vision centerSt LouisMissouri63128
Lisa Dinsmore
[email protected]
(314) 842-2020
Navin Tekwani, Dr (PRINCIPAL_INVESTIGATOR)
Rochester Ophthalmological GroupRochesterNew York14618
Rachel Rivera
[email protected]
585-244-6011
Paul Hartman, Dr (PRINCIPAL_INVESTIGATOR)
Houston Eye AssociatesHoustonTexas77008
Bhavna Shah, Dr
[email protected]
(832)-553-7113
Kevin Y Jong, Dr (PRINCIPAL_INVESTIGATOR)
R and R eye researchSan AntonioTexas78229
Maggie Hazen
[email protected]
210-424-2584
Anhtuan Nguyen, Dr (PRINCIPAL_INVESTIGATOR)

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