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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 3INTERVENTIONAL

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.

A Randomized, Double-blind, Multiple Dose, Parallel-group, Two-arm, Multicenter, Bioequivalence Study With Clinical Endpoint Comparing Bimatoprost Ophthalmic Solution 0.01% and LUMIGAN® (Bimatoprost Ophthalmic Solution) 0.01% in the Treatment of Subjects With Chronic Open-angle Glaucoma or Ocular Hypertension in Both Eyes

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. (NCT05401357) is a Phase 3 interventional studying Glaucoma, Open-Angle and Ocular Hypertension, sponsored by Amneal Pharmaceuticals, LLC. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

What Stage of Research Is This?

Phase 3 trials confirm efficacy and safety in large patient groups (often 300–3,000+) and form the evidence base for an FDA approval submission. For Glaucoma, Open-Angle, Phase 3 studies typically randomize participants between the investigational treatment and either a placebo or current standard of care. A successful Phase 3 result is the threshold most treatments need to clear before regulatory approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 168 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Glaucoma, Open-Angle subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: - Subjects willing and able to provide voluntary willing to sign a consent form and to follow protocol requirements. - Male or females aged ≥18 years. - Subjects having body mass index (BMI) ≥18.50 kg/m2. - Subjects with chronic open-angle glaucoma or ocular hypertension in both eyes. - Subjects 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 waiting period after previous treatment. - Adequate waiting period after previous treatment prior to baseline of any ocular hypotensive medications as per the table below (to minimize potential risk to subjects due to intraocular pressure (IOP) elevations during the waiting period after previous treatment, the Investigator may choose to substitute a parasympathomimetic or carbonic anhydrase inhibitor in place of a sympathomimetic, alpha-agonist, beta-adrenergic blocking agent, or prostaglandin; however, all the subjects must have discontinued their ocular hypotensive medications for the minimum waiting period after previous treatment. - Baseline (Day 0/hour 0) IOP ≥22 mm Hg and \<35 mm Hg in each eye, - Subjects' 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 following acceptable methods of contraception: 1. 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 2. Intrauterine device (IUD) or intrauterine system (IUS) ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * Subjects willing and able to provide voluntary informed consent and to follow protocol requirements. * Male or females aged ≥18 years. * Subjects having body mass index (BMI) ≥18.50 kg/m2. * Subjects with chronic open-angle glaucoma or ocular hypertension in both eyes. * Subjects 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 subjects due to intraocular pressure (IOP) elevations during the washout period, the Investigator may choose to substitute a parasympathomimetic or carbonic anhydrase inhibitor in place of a sympathomimetic, alpha-agonist, beta-adrenergic blocking agent, or prostaglandin; however, all the subjects must have discontinued their ocular hypotensive medications for the minimum washout period. * Baseline (Day 0/hour 0) IOP ≥22 mm Hg and \<35 mm Hg in each eye, * Subjects' 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 following acceptable methods of contraception: 1. 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 2. Intrauterine device (IUD) or intrauterine system (IUS) 3. Double barrier method of contraception (condom and occlusive cap or condom and spermicidal agent) 4. Male sterilization (at least 6 months prior to screening, should be the sole male partner for that subject) 5. Female sterilization (surgical bilateral oophorectomy) or tubal ligation at least 6 weeks prior to study participation 6. Total abstinence; partial abstinence is not acceptable * No history of addiction to any recreational drug or drug dependence or alcohol addiction. Exclusion Criteria: * 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 cataracts as per the Investigator's discretion will be allowed provided that the other inclusion/exclusion criteria are met). * 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. * Subjects 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, calcium channel blockers, angiotensin-converting enzyme inhibitors, etc.) * Central Corneal thickness (CCT) \<450 microns or \>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 * Subjects with documented history of positive serology for Hepatitis B Virus (HBV), Hepatitis C Virus (HCV) or Human Immunodeficiency Virus (HIV) infection * Subjects with positive urine pregnancy test * Subjects with confirmed novel coronavirus infection (COVID-19).

Treatments Being Tested

DRUG

Test - Bimatoprost 0.01% Ophthalmic Solution

Subjects in one arm will receive one drop of the test drug in both the eyes every evening at approximately 10:00 pm ± 1 hour for 42 days.

DRUG

Reference - LUMIGAN® (Bimatoprost 0.01% Ophthalmic Solution)

Subjects in the other arm will receive one drop of the reference drug in both the eyes every evening at approximately 10:00 pm for 42 days.

Locations (9)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Eye Research Foundation Inc.
Newport Beach, California, United States
North Bay Eye Associates, Inc.
Petaluma, California, United States
Volusia Eye Associates
New Smyrna Beach, Florida, United States
Clayton Eye Clinical Research, LLC
Morrow, Georgia, United States
Coastal Research Associates, LLC
Roswell, Georgia, United States
Toyos Clinic
Nashville, Tennessee, United States
Keystone Research
Austin, Texas, United States
Houston Eye Associates, North Loop
Houston, Texas, United States
Cheyenne Eye Clinic & Surgery Center
Cheyenne, Wyoming, United States

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT05401357), the sponsor (Amneal Pharmaceuticals, LLC), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT05401357 clinical trial studying?

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. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT05401357?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT05401357?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT05401357. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT05401357. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.