Trial comparing treatments for Primary Open Angle Glaucoma (POAG)
Official title A Study to Evaluate Efficacy and Safety of YSBP Compared to Lumigan in Patients With Glaucoma or Ocular Hypertension
ClinicalTrials.gov ID: NCT07661329
What this study is testing
What is Bimatoprost ophthalmic solution 0.01% YSBP?
This is an investigational eye drop being studied to see if it works as well as the standard treatment for primary open angle glaucoma. It is designed to lower eye pressure by helping the eye drain fluid more easily.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing whether YSBP works as well as Lumigan for treating primary open angle glaucoma or ocular hypertension.
- Who it's for
- You may be able to join if you have primary open angle glaucoma or ocular hypertension and are not using other eye drops that contain preservatives.
- What's involved
- You will use YSBP eye drops at home and may also use Lumigan drops in a separate group. You will have eye check‑ups at the clinic to measure your eye pressure and eye health.
- Time commitment
- The study lasts about 12 weeks, with clinic visits at the start and at the end to check your eye pressure and health.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- people willing and able to provide voluntary informed consent and to follow protocol requirements.
- Male or females aged ≥18 years.
- people with primary open-angle glaucoma (POAG) or ocular hypertension (OH) in both eyes
- people requiring treatment in both the eyes and able to discontinue the use of all ocular hypotensive medication(s) or switch ocular hypotensive...
- Adequate washout period prior to baseline (Day 0) of any ocular hypotensive medications
You likely can't join if
- Female people 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...
- Current corneal abnormalities that would prevent accurate IOP readings with tonometer.
- Functionally significant visual field loss as determined by perimetry.
See the full eligibility criteria
- people willing and able to provide voluntary informed consent and to follow protocol requirements.
- Male or females aged ≥18 years.
- people with primary open-angle glaucoma (POAG) or ocular hypertension (OH) in both eyes
- people 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
- people' 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.
- 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
- Female people 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...
- Current corneal abnormalities that would prevent accurate IOP readings with tonometer.
- Functionally significant visual field loss as determined by perimetry.
- people 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).
- people 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...
- Central Corneal thickness (CCT) \ 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.
- people with known cases of active Hepatitis B virus (HBV), Hepatitis C Virus (HCV) or Human Immunodeficiency Virus (HIV) infection.
- people with aphakia or history of herpes simplex keratitis
The study team makes the final eligibility decision.
Where it is enrolling
- Newport Beach, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Newport Beach, California, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.