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

Phase 3

Completed

• Conditions: Primary Open Angle Glaucoma or Ocular Hypertension
• Interventions: Drug: DE-117 ophthalmic solution; Drug: Latanoprost ophthalmic solution 0.005%

• Registration Number: NCT02822742
• Lead Sponsor: Santen Pharmaceutical Co., Ltd.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-06-30
• Study First Submitted QC: 2016-07-01
• Study Start: 2016-07-02
• Study First Posted: 2016-07-04
• Primary Completion: 2017-04-28
• Study Completion: 2017-04-28
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-16
• Last Update Posted: 2017-11-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
DE-117 ophthalmic solution and Latanoprost	Latanoprost ophthalmic solution 0.005%	DE-117 is Experimental. Latanoprost is Active Comparator.
DE-117 ophthalmic solution and Latanoprost	DE-117 ophthalmic solution	DE-117 is Experimental. Latanoprost is Active Comparator.

Primary Outcome Measures

Name	Time	Method
Intraocular pressure	Week 4