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Compares treatment options for Glaucoma, Open-Angle
Official title Bioequivalence Study With Clinical Endpoint Comparing Bimatoprost Ophthalmic Solution 0.01% and LUMIGAN® in the Treatment of Chronic Open-Angle Glaucoma or Ocular Hypertension in Both Eyes.
ClinicalTrials.gov ID: NCT05401357
What this study is testing
What is Test - Bimatoprost 0.01% Ophthalmic Solution?
Test - Bimatoprost 0.01% Ophthalmic Solution is an investigational medicine, being studied as a potential treatment for glaucoma, open-angle.
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 is a randomized, double-blind, two-treatment, single-period, parallel design, multiple dose at multiple clinical trial sites designed to demonstrate bioequivalence with clinical endpoint in subjects with chronic open-angle glaucoma or ocular hypertension in both eyes. Test Product - Bimatoprost ophthalmic solution, 0.01% of Amneal EU, Limited Reference Product - LUMIGAN® (bimatoprost ophthalmic solution) 0.01% of Allergan, Inc.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
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 having body mass index (BMI) ≥18.50 kg/m2.
- people with chronic open-angle glaucoma or ocular hypertension in both eyes.
- people requiring treatment of both eyes and able to discontinue the use of all ocular hypotensive medication(s) or switch ocular hypotensive...
You likely can't join if
- Female who are pregnant, lactating or planning a pregnancy.
- Contraindication or known hypersensitivity to Bimatoprost, related class of drugs, or any of the excipients of formulation.
- Current or past history of severe hepatic or renal impairment.
- Current or history within 2 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 Goldmann applanation tonometer.
- Functionally significant visual field loss in the Investigators' opinion.
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 having body mass index (BMI) ≥18.50 kg/m2.
- people with chronic open-angle glaucoma or ocular hypertension in both eyes.
- people requiring treatment of both 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 of any ocular hypotensive medications as per the table below (to minimize potential risk to people due to intraocular pressure (IOP) elevations during the washout period, the...
- Baseline (Day 0/hour 0) IOP ≥22 mm Hg and \<35 mm Hg in each eye,
- people' IOP is likely to be controlled with monotherapy as per the Investigator's discretion.
- Baseline best corrected visual acuity equivalent to Snellen acuity of 20/100 or better in each eye, using a logarithmic visual acuity chart for testing at 10 feet (3 meters).
- Women of childbearing potential (defined as women physiologically capable of becoming pregnant unless they are using an effective method of contraception during the dosing of the study drug) practicing any of the...
- 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 who are pregnant, lactating or planning a pregnancy.
- Contraindication or known hypersensitivity to Bimatoprost, related class of drugs, or any of the excipients of formulation.
- Current or past history of severe hepatic or renal impairment.
- Current or history within 2 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 Goldmann applanation tonometer.
- Functionally significant visual field loss in the Investigators' opinion.
- Subject 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 2 weeks prior to baseline of 1) a topical ophthalmic corticosteroid or 2) a topical corticosteroid
- Use within 1 month prior to baseline of 1) a systemic corticosteroid or 2) high dose salicylate therapy defined as 325 mg/day and taken on 3 consecutive days.
- Use within 6 months prior to baseline of intravitreal or subtenon injection of an ophthalmic corticosteroid
- Underwent within 6 months prior to baseline any other intraocular surgery (e.g., cataract surgery).
- Underwent within 12 months prior to baseline any refractive surgery, filtering surgery, or laser surgery for IOP reduction (e.g., laser trabeculoplasty).
- Amblyopia - only one sighted eye.
- people with a history of IOP previously uncontrolled on 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 retinal disease or other severe ocular pathology, such as glaucomatous damage with a cup/disk ratio greater than 0.8 (not including physiological cupping in the Investigators' opinion) or split fixation
- Chronic use of any systemic medication that may affect IOP with less than 3 months stable dosing regimen (i.e., sympathomimetic agents, beta-adrenergic blocking agents, alpha-agonists, alpha-adrenergic blocking agents...
- Central Corneal thickness (CCT) \ 650 microns
- Known history or presence of any uncontrolled systemic disease (e.g., cardiovascular disease, hypertension, diabetes mellitus, hepatic impairment, etc.)
- History of recurrent ocular seasonal allergies within the past 2 years
- 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 90 days before the first dose of the study drug
- people with documented history of positive serology for Hepatitis B Virus (HBV), Hepatitis C Virus (HCV) or Human Immunodeficiency Virus (HIV) infection
- people with positive urine pregnancy test
- people with confirmed novel coronavirus infection (COVID-19).
The study team makes the final eligibility decision.
Where it's taking place
- Newport Beach, California, United States
- Petaluma, California, United States
- New Smyrna Beach, Florida, United States
- Morrow, Georgia, United States
- Roswell, Georgia, United States
- Nashville, Tennessee, United States
- Austin, Texas, United States
- Houston, Texas, United States
- Cheyenne, Wyoming, 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 - 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?
Study sites include Newport Beach, California, United States; Petaluma, California, United States; New Smyrna Beach, Florida, United States; Morrow, Georgia, United States; Roswell, Georgia, United States; Nashville, Tennessee, United States and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.