DE-117 Spectrum 5 Study

• Status: Recruiting
• Trial end date: 2020-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Santen Inc.
• Treatments: Ophthalmic Solutions; Pharmaceutical Solutions

Criteria

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.

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.