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

Primary Open Angle Glaucoma or Ocular Hypertension Clinical Trial

Official title:

A Phase III, Open-label, Single-arm, Multi-center Study Assessing the Safety and Efficacy of DE-117 Ophthalmic Solution in Subjects With Primary Open-angle Glaucoma or Ocular Hypertension Who Are Non-/Low-responders to Latanoprost Ophthalmic Solution: FUJI Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02822742
• Other study ID #: 01171506
• Status: Completed
• Phase: Phase 3
• First received: June 30, 2016
• Last updated: November 16, 2017
• Start date: July 2, 2016
• Est. completion date: April 28, 2017

Study information

• Verified date: November 2017
• Source: Santen Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: April 28, 2017
• Est. primary completion date: April 28, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Hypertension
• Ocular Hypertension
• Primary Open Angle Glaucoma or Ocular Hypertension

Intervention

Drug:
• DE-117 ophthalmic solution

• Latanoprost ophthalmic solution 0.005%

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Santen Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intraocular pressure		Week 4