NCT02822729

Brief Summary

The purposes of this study are to evaluate the long-term safety and intraocular pressure-lowering efficacy of DE-117 ophthalmic solution monotherapy and concomitant use of DE-117 ophthalmic solution with timolol ophthalmic solution 0.5% in patients with open angle glaucoma or ocular hypertension.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
125

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jul 2016

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
1 day until next milestone

Study Start

First participant enrolled

July 1, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 4, 2016

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 9, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 9, 2017

Completed
Last Updated

November 20, 2017

Status Verified

November 1, 2017

Enrollment Period

1.4 years

First QC Date

June 30, 2016

Last Update Submit

November 16, 2017

Conditions

Open Angle Glaucoma or Ocular Hypertension

Outcome Measures

Primary Outcomes (1)

  • Evaluation of adverse events

    Week 52

Study Arms (3)

DE-117 ophthalmic solution (Group1)

EXPERIMENTAL

Monotherapy

Drug: DE-117 ophthalmic solution

DE-117 ophthalmic solution (Group2)

EXPERIMENTAL

Monotherapy

Drug: DE-117 ophthalmic solution

DE-117 ophthalmic solution + Timolol (Group3)

OTHER

Concomitant Use

Drug: DE-117 ophthalmic solutionDrug: Timolol ophthalmic solution

Interventions

DE-117 ophthalmic solutionDRUG
DE-117 ophthalmic solution (Group1)DE-117 ophthalmic solution (Group2)DE-117 ophthalmic solution + Timolol (Group3)
Timolol ophthalmic solutionDRUG
DE-117 ophthalmic solution + Timolol (Group3)

Eligibility Criteria

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

You may qualify if:

  • Patients with 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, Lu F, Kawata H, Iwata A, Odani-Kawabata N. Twelve-month efficacy and safety of omidenepag isopropyl, a selective EP2 agonist, in open-angle glaucoma and ocular hypertension: the RENGE study. Jpn J Ophthalmol. 2021 Nov;65(6):810-819. doi: 10.1007/s10384-021-00868-y. Epub 2021 Sep 8.

    PMID: 34495425DERIVED

MeSH Terms

Conditions

Glaucoma, Open-AngleOcular Hypertension

Condition Hierarchy (Ancestors)

GlaucomaEye Diseases

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 30, 2016

First Posted

July 4, 2016

Study Start

July 1, 2016

Primary Completion

November 9, 2017

Study Completion

November 9, 2017

Last Updated

November 20, 2017

Record last verified: 2017-11

Locations

JP(1)