A Study to Evaluate Efficacy and Safety of YSBP Compared to Lumigan in Patients With Glaucoma or Ocular Hypertension
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorYS Life Science Co., Ltd.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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).
Trial design
Design model
Parallel
Treatments tested in this trial
Bimatoprost ophthalmic solution 0.01% YSBP
DrugYSBP
bimatoprost ophthalmic solution 0.01% (Lumigan®)
DrugLumigan®
Treatment groups
600 Participants
are divided into 2 treatment groupsGroup A: YSBPExperimental treatment 1 intervention
Group B: LumiganActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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)
Time frame
Week 12Sponsors and contacts
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Source ClinicalTrials.gov