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

Santen

Status and phase: Completed; Phase 3

Conditions: Open Angle Glaucoma or Ocular Hypertension

Treatments: Drug: Timolol ophthalmic solution; Drug: DE-117 ophthalmic solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT02822729

01171504

Details and patient eligibility

About

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.

Enrollment: 125 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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125 participants in 3 patient groups

DE-117 ophthalmic solution (Group1)

Experimental group

Description:

Monotherapy

Treatment:

Drug: DE-117 ophthalmic solution

DE-117 ophthalmic solution (Group2)

Experimental group

Description:

Monotherapy

Treatment:

Drug: DE-117 ophthalmic solution

DE-117 ophthalmic solution + Timolol (Group3)

Other group

Description:

Concomitant Use

Treatment:

Drug: DE-117 ophthalmic solution

Drug: Timolol ophthalmic solution