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600 Participants NeededMy employer runs this trial

Bimatoprost Ophthalmic Solution for Glaucoma

Recruiting at 23 trial locations
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: YS Life Science Co., Ltd.
Must be taking: Ocular hypotensive
Must not be taking: Corticosteroids, sympathomimetics, others
Disqualifiers: Pregnancy, Severe hepatic impairment, others
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of 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.

Are You a Good Fit for This Trial?

This trial is for people with primary open angle glaucoma or high eye pressure (ocular hypertension) who need treatment to lower their eye pressure. Participants should not have other serious eye conditions or allergies to the study medications.

Inclusion Criteria

My eye pressure can be managed with a single medication.
No history of addiction to recreational drugs, drug dependence, or alcohol addiction
Subjects willing and able to provide voluntary informed consent and to follow protocol requirements
See 7 more

Exclusion Criteria

I have significant vision loss as shown by a visual field test.
I did not respond to bimatoprost treatment alone.
Use of contact lens within 1 week prior to baseline
See 22 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either YSBP or Lumigan ophthalmic solution for the treatment of primary open-angle glaucoma or ocular hypertension

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Trial Overview

The study compares two types of bimatoprost 0.01% eye drops: a new preservative-free version and the standard Lumigan®. Patients are randomly assigned to one group, and neither they nor their doctors know which drop they're using.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: YSBPExperimental Treatment1 Intervention
Group II: LumiganActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

YS Life Science Co., Ltd.

Lead Sponsor

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