DE-117 Spectrum 5 Study

An Open-Label, Multicenter Study Assessing the Efficacy and Safety of DE-117 Ophthalmic Solution 0.002% in Latanoprost Low/Non-Responder Subjects Diagnosed With Primary Open-Angle Glaucoma or Ocular Hypertension - Spectrum 5 Study

Santen will evaluate the intraocular pressure (IOP) lowering effect and efficacy of DE-117 ophthalmic solution 0.002% in latanoprost low/non-responder subjects diagnosed with POAG or OHT

Inclusion Criteria:

• Patients with Primary Open-Angle Glaucoma or Ocular Hypertension in one or both eyes.
• Provide signed written informed consent.
• Diagnosis of POAG or OHT in both eyes.
• Qualifying corrected visual acuity in each eye.
• Qualifying central corneal thickness in each eye.
• Qualifying Day 1 IOP measurement at 3 time-points in both eyes after latanoprost Run-in Period.
• Qualifying Anterior chamber angle.
• Qualifying IOP measurement at 3 time-points during latanoprost Run-in Period.

Exclusion Criteria:

• Patients who cannot safely discontinue use of Ocular Hypotensive Medications during Washout.
• Patients with prior exposure to DE-117.
• History of ocular surgery specifically intended to lower IOP
• Advanced glaucoma in either eye.
• Any corneal abnormality or other condition interfering with or preventing reliable Goldmann applanation tonometry.
• Any ocular surgery or ocular laser treatment within 180 days prior to Visit 1 (Screening) and throughout the study in either eye.
• Females who are pregnant, nursing, or planning a pregnancy.