Clinical Trials

Inclusion Criteria:

• ≥ 18 years of age on the date the informed consent form (ICF) is signed.
• Either gender.
• Subjects with two healthy eyes with the crystalline lens, without glaucoma or any other clinically significant eye diseases.
• Intraocular pressure between 16 and 28 mmHg in both eyes between 9AM and 12PM (± 15 minutes) at the Screening Visit.
• Be able and willing to provide signed informed consent and follow study instructions.
• Ability to cooperate with the examinations required for the study and be able to attend all study visits.
• If a contract lens wearer, willing to remove contact lenses 3 days prior to Visit 2 and not wear contact lenses for the remainder of the study.
• Best-corrected visual acuity (BCVA) using Early Treatment of Diabetic Retinopathy Study (ETDRS) chart of +0.4 logMAR units (Snellen equivalent ~ 20/50) or better in each eye.

Exclusion Criteria: 

Ocular

• Subjects with narrow angles (3 quadrants with less than Grade 2 according to Shaffer anterior angle graded system), angle closure or a history of angle closure, clinically significant peripheral anterior synechiae, or peripheral iridotomy in either eye.
• Subjects with a central corneal thickness less than 480 µm or greater than 620 µm in either eye.
• Chronic or recurrent inflammatory eye diseases in either eye.
• Ocular infection or ocular inflammation in the past 3 months in either eye.
• Ocular trauma other than corneal abrasion within the past 6 months in either eye.
• Clinically significant retinal disease (e.g., severe diabetic retinopathy, exudative or severe non-exudative macular degeneration) in either eye.
• Cornea pathologic changes preventing reliable measurement (e.g., scarring, opacity) in either eye.
• Previous intraocular surgery or laser procedure in either eye.
• Previous corneal refractive surgery in either eye.
• Myopia greater than -6.00D, or hyperopia greater than +2.00D in either eye.
• Severe dry eye in either eye.
• Serious hypersensitivity to topical anesthetic eye drops.
• Use of any topical ophthalmic medications other than lubricants and artificial tears within the 30 days prior to the Screening Visit or during the study, in either eye.
• Lack of suitable episcleral vein for EVP measurement.

Systemic

• If female, subjects must either be incapable of pregnancy because of bilateral oophorectomy, hysterectomy, bilateral tubal ligation, or be post-menopausal (have been amenorrheic for at least 2 years) or must use an effective (e.g., double barrier) method of birth control for the duration of the study. Female subjects of childbearing potential must have a negative pregnancy test and not be breastfeeding.
• Participation in any interventional study within the past 30 days prior to Screening Visit.
• Subjects with uncontrolled chronic diseases (e.g., uncontrolled hypertension/diabetes).
• Using medications that are known to affect IOP, EVP, and aqueous flow rate within 30 days prior to the Screening Visit and during the study including: systemic/inhaled steroids, β-adrenergic antagonists, α-adrenergic agonists and antagonists, calcium channel blockers, diuretics, and vasodilators (e.g., nitroglycerin, sildenafil/tadalafil).
• Using marijuana or marijuana derivatives.
• Subjects with known contraindications to NO treatments (e.g., alcohol abuse).
• Subjects with a known hypersensitivity or contraindications to any of the ingredients in the study medications.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 6/29/23. Questions regarding updates should be directed to the study team contact.