H-1337 Ophthalmic Solution Phase 1/2

Inclusion Criteria

• 18 years of age or older.
• Diagnosis of bilateral primary open angle glaucoma or ocular hypertension.
• One qualifying IOP criteria after washout:
• Baseline (Day 0) at T0 (T0 = 8 am ± 30 min) IOP ≥ 23 mmHg in the study eye.
• IOP criteria after washout ≤ 32 mmHg oculus uterque (OU) at all time points.
• Best-corrected visual acuity (BCVA) in both eyes of 20/200 or better on Snellen, equivalent to + 1.0 log Mar.
• Able and willing to sign informed consent, follow study instructions and complete all study visits.
• As applicable, must be willing to discontinue the use of all ocular hypotensive medication(s) in both eyes prior to receiving the study medication and for the entire course of the study.
• Able to self-administer or have a caretaker administer study eye drops.

Exclusion Criteria

Ophthalmic:

Exclude subjects with:

• Closed or very narrow angles (Grade 0-1) (see Section 5, gonioscopy) or those the investigator judges as occludable and/or with evidence of peripheral anterior synechiae (PAS) ≥ 180 degrees by gonioscopy within 6 months prior to Screening Visit in either eye. (Patent laser iridotomy with Grade 1-2 angles is acceptable in either eye, providing the PAS criteria are still met).
• Previous glaucoma intraocular surgery in either eye. Prior laser trabeculoplasty (ALT or SLT) in either eye is allowed if performed more than 6 months prior to Screening Visit.
• Any non-glaucoma intraocular surgery within 3 months prior to Screening Visit in either eye.
• Intraocular laser surgery such as laser capsulotomy, laser iridotomy, and/or retinal laser within 1 month prior to Screening Visit in either eye.
• Significant media opacity in either eye that would impede adequate posterior segment examination.
• Contraindications to pupil dilation in either eye.
• Other forms of glaucoma such as primary congenital, juvenile onset, chronic angle closure, and secondary glaucoma of any type including steroid-induced, inflammation-induced, or exfoliation glaucoma in either eye. Pigment dispersion syndrome/glaucoma is permitted in either eye.
• Clinically significant corneal dystrophy, epithelial or endothelial disease, corneal irregularities or scarring that, in the investigator's judgment, would impede an accurate measurement of IOP or visualization of intraocular anatomy in the study eye.
• History of refractive surgery in either eye (i.e., radial keratotomy, photorefractive keratectomy, LASIK).
• History of corneal cross-linking procedure in either eye.
• Unwillingness to be contact lens free during study participation.
• Any history of uveitis, keratitis, or scleritis in either eye.
• Any history of penetrating ocular trauma in either eye.
• History within 3 months prior to Screening Visit of clinically significant moderate or severe chronic or active blepharitis, ocular dermatitis, or recent ocular conjunctivitis and/or ocular inflammation in either eye. Mild blepharitis, hyperemia (due to prostaglandin use) and/or blepharitis, and/or mild inactive seasonal allergic conjunctivitis and non-infective dermatitis are acceptable.
• Corneal thickness 620 µm in the study eye. Pachymetry measurement within 6 months prior to Screening Visit is acceptable.
• Advanced or severe glaucoma with progressive visual field loss and/or optic nerve changes in either eye that, in the investigator's best judgment, prevent safe withdrawal from treatment for the time periods required in this protocol.
• Progressive retinal (including, but not limited to worsening dry age-related macular degeneration (AMD), presence of active wet AMD, or unstable diabetic retinopathy) or optic nerve disease in either eye from any cause other than glaucoma.
• Any prior intravitreal steroid injection in either eye.
• Sub-tenon's, sub-conjunctival or periocular steroid injections within the 6 months prior to Screening Visit in either eye.
• Any use of ocular topical corticosteroids in either eye within 7