A Study Assessing the Efficacy and Safety of DE-117 Ophthalmic Solution in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension -AYAME Study-
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-
1 other identifier
interventional
253
1 country
1
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%.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Dec 2015
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 3, 2015
CompletedStudy Start
First participant enrolled
December 6, 2015
CompletedFirst Posted
Study publicly available on registry
December 8, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 10, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
February 10, 2017
CompletedNovember 20, 2017
November 1, 2017
1.2 years
December 3, 2015
November 16, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Intraocular pressure
Week 4
Study Arms (4)
Placebo ophthalmic solution
PLACEBO COMPARATOREyedrop
DE-117 ophthalmic solution low
EXPERIMENTALEyedrop
DE-117 ophthalmic solution high
EXPERIMENTALEyedrop
Latanoprost ophthalmic solution 0.005%
ACTIVE COMPARATOREyedrop
Interventions
Eligibility Criteria
You may qualify if:
- Primary open angle glaucoma or ocular hypertension
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Unknown Facility
Tokyo, Osaka, Japan
Related Publications (1)
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.
PMID: 32533949DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 3, 2015
First Posted
December 8, 2015
Study Start
December 6, 2015
Primary Completion
February 10, 2017
Study Completion
February 10, 2017
Last Updated
November 20, 2017
Record last verified: 2017-11