To Investigate the Safety and Efficacy of DE-104 Ophthalm... | NCT00656240

Studies
To Investigate the Safety and Efficacy of DE-104 Ophthalmic Solution to Treat Open-Angle Glaucoma or Ocular Hypertension

NCT00656240

Sponsor

Santen Pharmaceutical Co., Ltd.

Status

Completed

Last Update Posted

Mar 16, 2009Estimated

Enrollment

Not provided

Phase

Phase 2

Conditions

Open-Angle Glaucoma
Ocular Hypertension

Interventions

DE-104 ophthalmic solution
DE-104 vehicle

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Not provided

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Apr 7, 2008

First Submission Date that Met QC Criteria

Apr 10, 2008

First Posted Date

Apr 11, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 12, 2009

Last Update Posted Date

Mar 16, 2009Estimated

Description Module

Brief Summary

To investigate the intraocular pressure (IOP)-lowering effect and safety of DE-104 ophthalmic solution in patients with Primary Open-Angle Glaucoma or Ocular Hypertension

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

No data available

No data is available for this block.

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Label	Type	Description	Intervention Names
1	Experimental		Drug: DE-104 ophthalmic solution
2	Experimental		Drug: DE-104 vehicle

Name	Type	Description	Arm Group Labels	Other Names
DE-104 ophthalmic solution	Drug		1
DE-104 vehicle

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosed with primary open-angle glaucoma or ocular hypertension.
Provided signed, written informed consent.
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.

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

74 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D005902	Glaucoma, Open-Angle
D009798	Ocular Hypertension

Ancestor Terms

ID	Term
D005901	Glaucoma
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided