A Long-term Study of DE-117 Ophthalmic Solution Monotherapy and Concomitant Use of DE-117 Ophthalmic Solution With Timolol Ophthalmic Solution in Patients With OAG or OH: RENGE Study

Open Angle Glaucoma or Ocular Hypertension Clinical Trial

Official title:

A Long-term Open-label Study of DE-117 Ophthalmic Solution Monotherapy and Concomitant Use of DE-117 Ophthalmic Solution With Timolol Ophthalmic Solution in Patients With Open-angle Glaucoma or Ocular Hypertension : RENGE Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02822729
• Other study ID #: 01171504
• Status: Completed
• Phase: Phase 3
• First received: June 30, 2016
• Last updated: November 16, 2017
• Start date: July 1, 2016
• Est. completion date: November 9, 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 evaluate the long-term safety and intraocular pressure-lowering efficacy of DE-117 ophthalmic solution monotherapy and concomitant use of DE-117 ophthalmic solution with timolol ophthalmic solution 0.5% in patients with open angle glaucoma or ocular hypertension.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 125
• Est. completion date: November 9, 2017
• Est. primary completion date: November 9, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Patients with 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
• Open Angle Glaucoma or Ocular Hypertension

Intervention

Drug:
• DE-117 ophthalmic solution

• Timolol ophthalmic solution

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	Evaluation of adverse events		Week 52