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.

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 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).

What this study is about