NCT02822742

Brief Summary

The purposes of this study are to investigate the effect of intraocular pressure lowering efficacy and safety of DE-117 ophthalmic solution in subjects with primary open-angle glaucoma or ocular hypertension who are non-/low-responders to latanoprost ophthalmic solution.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jul 2016

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

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

June 30, 2016

Completed
2 days until next milestone

Study Start

First participant enrolled

July 2, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 4, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 28, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 28, 2017

Completed
Last Updated

November 20, 2017

Status Verified

November 1, 2017

Enrollment Period

10 months

First QC Date

June 30, 2016

Last Update Submit

November 16, 2017

Conditions

Primary Open Angle Glaucoma or Ocular Hypertension

Outcome Measures

Primary Outcomes (1)

  • Intraocular pressure

    Week 4

Study Arms (1)

DE-117 ophthalmic solution and Latanoprost

OTHER

DE-117 is Experimental. Latanoprost is Active Comparator.

Drug: DE-117 ophthalmic solutionDrug: Latanoprost ophthalmic solution 0.005%

Interventions

DE-117 ophthalmic solutionDRUG
DE-117 ophthalmic solution and Latanoprost
Latanoprost ophthalmic solution 0.005%DRUG
DE-117 ophthalmic solution and Latanoprost

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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, Japan

Location

Related Publications (1)

  • Aihara M, Ropo A, Lu F, Kawata H, Iwata A, Odani-Kawabata N, Shams N. Intraocular pressure-lowering effect of omidenepag isopropyl in latanoprost non-/low-responder patients with primary open-angle glaucoma or ocular hypertension: the FUJI study. Jpn J Ophthalmol. 2020 Jul;64(4):398-406. doi: 10.1007/s10384-020-00748-x. Epub 2020 Jun 22.

    PMID: 32572719DERIVED

MeSH Terms

Conditions

Glaucoma, Open-AngleOcular Hypertension

Condition Hierarchy (Ancestors)

GlaucomaEye Diseases

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 30, 2016

First Posted

July 4, 2016

Study Start

July 2, 2016

Primary Completion

April 28, 2017

Study Completion

April 28, 2017

Last Updated

November 20, 2017

Record last verified: 2017-11

Locations

JP(1)