NCT01343082

Brief Summary

Safety and IOP (intraocular pressure) lowering effect of DE-111 ophthalmic solution will be evaluated in open-angle glaucoma or ocular hypertension patients, in an open-label, multicenter study.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
148

participants targeted

Target at P25-P50 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

April 24, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 27, 2011

Completed
4 days until next milestone

Study Start

First participant enrolled

May 1, 2011

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
2.2 years until next milestone

Results Posted

Study results publicly available

May 14, 2015

Completed
Last Updated

June 15, 2015

Status Verified

May 1, 2015

Enrollment Period

1.8 years

First QC Date

April 24, 2011

Results QC Date

April 28, 2015

Last Update Submit

May 19, 2015

Conditions

Open Angle Glaucoma or Ocular Hypertension

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline in IOP (Intraocular Pressure) at End of Study

    Treatment period: Week 0 (Baseline) and Week 52 (End of Study)

Study Arms (1)

1

EXPERIMENTAL

DE-111 ophthalmic solution

Drug: DE-111 ophthalmic solution

Interventions

DE-111 ophthalmic solutionDRUG
1

Eligibility Criteria

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

You may qualify if:

  • Diagnosed with open angle glaucoma or ocular hypertension
  • Provided signed, written informed consent
  • years of age and older
  • If a subject is a female of childbearing potential, she must utilize reliable contraceptive throughout the study, and must have a negative urine pregnancy test prior to enrollment into this study

You may not qualify if:

  • Females who are pregnant, nursing or planning a pregnancy, or females of childbearing potential who are not using a reliable method of contraception.
  • Presence of any abnormality or significant illness that could be expected to interfere with the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Santen study sites

Osaka, Osaka, Japan

Location

MeSH Terms

Conditions

Glaucoma, Open-AngleOcular Hypertension

Condition Hierarchy (Ancestors)

GlaucomaEye Diseases

Results Point of Contact

Title
General Manager of Clinical Development Group
Organization
Santen Pharmaceutical Co., Ltd.
clinical@santen.co.jp
+81-6-4802-9341

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

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

April 24, 2011

First Posted

April 27, 2011

Study Start

May 1, 2011

Primary Completion

March 1, 2013

Last Updated

June 15, 2015

Results First Posted

May 14, 2015

Record last verified: 2015-05

Locations

JP(1)