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Safety and Efficacy Study of DE-104 Ophthalmic Solution to Treat Open-Angle Glaucoma or Ocular Hypertension

Primary Purpose

Open-Angle Glaucoma, Ocular Hypertension

Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
DE-104 ophthalmic solution, low concentration
DE-104 ophthalmic solution, medium concentration
DE-104 ophthalmic solution, high concentration
DE-104 vehicle
Sponsored by
Santen Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional trial for Open-Angle Glaucoma

Eligibility Criteria

20 Years - 74 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Osaka, Japan

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

1

2

3

4

Arm Description

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
April 7, 2008
Last Updated
March 12, 2009
Sponsor
Santen Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT00657579
Brief Title
Safety and Efficacy Study of DE-104 Ophthalmic Solution to Treat Open-Angle Glaucoma or Ocular Hypertension
Official Title
A Randomized, Double-Masked, Parallel-Group, Dose-Response Trial of DE-104 Ophthalmic Solution in Subjects With Open-Angle Glaucoma or Ocular Hypertension
Study Type
Interventional

2. Study Status

Record Verification Date
March 2009
Overall Recruitment Status
Completed
Study Start Date
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Primary Completion Date
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Study Completion Date
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3. Sponsor/Collaborators

Name of the Sponsor
Santen Pharmaceutical Co., Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
To investigate the dose-response relationship of DE-104 ophthalmic solution in lowering intraocular pressure (IOP) in subjects with Primary Open-Angle Glaucoma or Ocular Hypertension

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Open-Angle Glaucoma, Ocular Hypertension

7. Study Design

Study Phase
Phase 2

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Experimental
Arm Title
3
Arm Type
Experimental
Arm Title
4
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
DE-104 ophthalmic solution, low concentration
Intervention Type
Drug
Intervention Name(s)
DE-104 ophthalmic solution, medium concentration
Intervention Type
Drug
Intervention Name(s)
DE-104 ophthalmic solution, high concentration
Intervention Type
Drug
Intervention Name(s)
DE-104 vehicle

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Osaka, Japan
City
Osaka
Country
Japan

12. IPD Sharing Statement

Learn more about this trial

Safety and Efficacy Study of DE-104 Ophthalmic Solution to Treat Open-Angle Glaucoma or Ocular Hypertension

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