A Comparative, Randomized, Investigator-blind, Active-controlled, Parallel-group, Multicenter, Clinical Endpoint Study

Exclusion Criteria25

• Female subjects 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 corneal abnormalities that would prevent accurate IOP readings with tonometer.
• Functionally significant visual field loss as determined by perimetry.
• Subjects 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).
• Underwent any filtering surgery, or laser surgery for IOP reduction (e.g., laser trabeculoplasty) within 3 months prior to baseline or refractive surgery at any time.
• Subjects 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, calcium channel blockers, angiotensin-converting enzyme inhibitors, etc.)
• Central Corneal thickness (CCT) <480 microns or >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.
• Subjects with known cases of active Hepatitis B virus (HBV), Hepatitis C Virus (HCV) or Human Immunodeficiency Virus (HIV) infection.
• Subjects with aphakia or history of herpes simplex keratitis