Newport Beach, CANCT06267274Now EnrollingIRB Ready

Open-angle Glaucoma Clinical Trial in Newport Beach, CA

Access cutting-edge open-angle glaucoma treatment through this clinical trial at a research site in Newport Beach. Study-provided care at no cost to qualified participants.

Sponsored by Amneal Pharmaceuticals, LLC

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Expert Care in Newport Beach

Access open-angle glaucoma specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related open-angle glaucoma treatment provided free

Apply for This Newport Beach Location

Check if you qualify for this open-angle glaucoma clinical trial in Newport Beach, CA

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Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Local to Newport Beach

    Convenient for CA residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Newport Beach site if eligible
  4. 4Begin participation

About This Open-angle Glaucoma Study in Newport Beach

A randomized, double-blind, parallel-group, two-arm, multiple dose, multicenter, clinical endpoint bioequivalence study

Sponsor: Amneal Pharmaceuticals, LLC

Who Can Participate

Inclusion Criteria

Subjects willing and able to provide voluntary informed consent and to follow protocol requirements.
Male or females aged ≥18 years.
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 (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 \<28 mm Hg in each eye, with difference between the IOP in left and right eyes not being more than 5 mm Hg
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:
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

Exclusion Criteria

Female who are pregnant, lactating or planning a pregnancy.
Subjects recently diagnosed with open-angle glaucoma or ocular hypertension and who are treatment naive.
Contraindication or known hypersensitivity to Bimatoprost, related class of drugs, or any of the excipients of formulation.
Current or 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 30 days before the first dose of the study drug.
Subjects with known 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.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Newport Beach?

Yes, this clinical trial (NCT06267274) has an active research site in Newport Beach, CA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Open-angle Glaucoma Treatment Options in Newport Beach, CA

If you're searching for open-angle glaucoma treatment options in Newport Beach, CA, this clinical trial (NCT06267274) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Newport Beach research site is actively enrolling participants for this clinical trial. You'll receive care from experienced open-angle glaucoma specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all open-angle glaucoma clinical trials near you to find additional studies recruiting in your area.

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