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

Primary Purpose

Primary Open Angle Glaucoma, Ocular Hypertension

Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
Placebo ophthalmic solution
DE-117 ophthalmic solution low
DE-117 ophthalmic solution high
Latanoprost ophthalmic solution 0.005%
Sponsored by
Santen Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Open Angle Glaucoma

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Experimental

Active Comparator

Arm Label

Placebo ophthalmic solution

DE-117 ophthalmic solution low

DE-117 ophthalmic solution high

Latanoprost ophthalmic solution 0.005%

Arm Description

Eyedrop

Eyedrop

Eyedrop

Eyedrop

Outcomes

Primary Outcome Measures

Intraocular pressure

Secondary Outcome Measures

Full Information

First Posted
December 3, 2015
Last Updated
November 16, 2017
Sponsor
Santen Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02623738
Brief Title
A Study Assessing the Efficacy and Safety of DE-117 Ophthalmic Solution in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension -AYAME Study-
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-
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
December 6, 2015 (Actual)
Primary Completion Date
February 10, 2017 (Actual)
Study Completion Date
February 10, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Santen Pharmaceutical Co., Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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%.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Open Angle Glaucoma, Ocular Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
253 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo ophthalmic solution
Arm Type
Placebo Comparator
Arm Description
Eyedrop
Arm Title
DE-117 ophthalmic solution low
Arm Type
Experimental
Arm Description
Eyedrop
Arm Title
DE-117 ophthalmic solution high
Arm Type
Experimental
Arm Description
Eyedrop
Arm Title
Latanoprost ophthalmic solution 0.005%
Arm Type
Active Comparator
Arm Description
Eyedrop
Intervention Type
Drug
Intervention Name(s)
Placebo ophthalmic solution
Intervention Type
Drug
Intervention Name(s)
DE-117 ophthalmic solution low
Intervention Type
Drug
Intervention Name(s)
DE-117 ophthalmic solution high
Intervention Type
Drug
Intervention Name(s)
Latanoprost ophthalmic solution 0.005%
Other Intervention Name(s)
Latanoprost
Primary Outcome Measure Information:
Title
Intraocular pressure
Time Frame
Week 4

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
City
Tokyo, Osaka
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
32533949
Citation
Aihara M, Lu F, Kawata H, Iwata A, Odani-Kawabata N, Shams NK. Omidenepag Isopropyl Versus Latanoprost in Primary Open-Angle Glaucoma and Ocular Hypertension: The Phase 3 AYAME Study. Am J Ophthalmol. 2020 Dec;220:53-63. doi: 10.1016/j.ajo.2020.06.003. Epub 2020 Jun 10. Erratum In: Am J Ophthalmol. 2021 Nov;231:211.
Results Reference
derived

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

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