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NCT02623738 Clinical Trial

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

Ocular Hypertension Clinical Trial

Official title:
A Phase II/III Randomized, Double-masked, Controlled, Parallel Group, Multicenter Study Assessing the Efficacy and Safety of DE-117 Ophthalmic Solution in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension -AYAME Study-

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02623738
Other study ID # 01171503
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received December 3, 2015
Last updated November 16, 2017
Start date December 6, 2015
Est. completion date February 10, 2017

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

Clinical Trial Summary

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%.

Recruitment information / eligibility
Status Completed
Enrollment 253
Est. completion date February 10, 2017
Est. primary completion date February 10, 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Placebo ophthalmic solution

• DE-117 ophthalmic solution low

• DE-117 ophthalmic solution high

• 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
See also
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