A Study Assessing the Efficacy and Safety of DE-117 Ophthalmic Solution in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension -AYAME Study-

Santen

Status and phase: Completed; Phase 3; Phase 2

Conditions: Ocular Hypertension; Primary Open Angle Glaucoma

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT02623738

01171503

Details and patient eligibility

About

The purposes of this study are to determine the optimal concentration of DE-117 ophthalmic solution compared to the placebo ophthalmic solution and to determine if intraocular pressure reduction after 4 weeks of treatment with DE-117 ophthalmic solution is non-inferior to latanoprost ophthalmic solution 0.005%.

Enrollment: 253 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: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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253 participants in 4 patient groups, including a placebo group

Placebo ophthalmic solution

Placebo Comparator group

Description:

Eyedrop

Treatment:

Drug: Placebo ophthalmic solution

DE-117 ophthalmic solution low

Experimental group

Description:

Eyedrop

Treatment:

Drug: DE-117 ophthalmic solution low

DE-117 ophthalmic solution high

Experimental group

Description:

Eyedrop

Treatment:

Drug: DE-117 ophthalmic solution high

Latanoprost ophthalmic solution 0.005%

Active Comparator group

Description:

Eyedrop

Treatment:

Drug: Latanoprost ophthalmic solution 0.005%