DE-117 Spectrum 5 Study

Santen

Status and phase: Completed; Phase 3

Conditions: Primary Open-angle Glaucoma and Ocular Hypertension

Treatments: Drug: DE-117 Ophthalmic Solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT03697811

011711IN

Details and patient eligibility

About

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

Enrollment: 107 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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107 participants in 1 patient group

DE-117 Ophthalmic Solution 0.002%

Experimental group

Description:

Interventional treatment will be made with DE-117 Ophthalmic Solution 0.002% once daily in the evening for the duration of the 3 month treatment period.

Treatment:

Drug: DE-117 Ophthalmic Solution