A Study Assessing the Safety and Efficacy of DE-117 in Subjects With POAG or OH Who Are Non-/Low-responders to Latanoprost: FUJI Study

Santen

Status and phase: Completed; Phase 3

Conditions: Primary Open Angle Glaucoma or Ocular Hypertension

Treatments: Drug: Latanoprost ophthalmic solution 0.005%; Drug: DE-117 ophthalmic solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT02822742

01171506

Details and patient eligibility

About

The purposes of this study are to investigate the effect of intraocular pressure lowering efficacy and safety of DE-117 ophthalmic solution in subjects with primary open-angle glaucoma or ocular hypertension who are non-/low-responders to latanoprost ophthalmic solution.

Enrollment: 26 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Primary open angle glaucoma or ocular hypertension

Exclusion criteria

• Patients at risk of progression of visual field loss
• Patients with severe visual field defect
• Patients with any diseases that preclude participation in this study for safety reasons

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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26 participants in 1 patient group

DE-117 ophthalmic solution and Latanoprost

Other group

Description:

DE-117 is Experimental. Latanoprost is Active Comparator.

Treatment:

Drug: DE-117 ophthalmic solution

Drug: Latanoprost ophthalmic solution 0.005%