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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
United States
Study Type
Interventional
Intervention
DE-104 ophthalmic solution, low concentration
DE-104 ophthalmic solution, medium concentration
DE-104 ophthalmic solution, high concentration
Placebo
0.005% latanoprost
Sponsored by
Santen Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Open-Angle Glaucoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Provided signed, written informed consent.
  • Diagnosed with primary open-angle glaucoma or ocular hypertension.
  • 18 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.

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

  • Sall Research Medical Center
  • USC Department of Ophthalmology
  • Wolstan Eye Associates
  • East Florida Eye Institute
  • Seidenberg Protzko Eye Associates
  • University of Nebraska Medical Center
  • Rochester Ophthalmological Group, PC
  • Cornerstone Eye Care
  • Associated Glaucoma Consultants
  • Keystone Research, Ltd.
  • David Shulman, MD P-A
  • Eye Clinics of South Texas
  • Medical Center Ophthalmology Associates
  • Virginia Eye Consultants

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Active Comparator

Arm Label

1

2

3

4

5

Arm Description

<described in intervention>

<described in intervention>

<described in intervention>

<described in intervention>

<described intervention>

Outcomes

Primary Outcome Measures

To investigate the dose-response relationship of DE-104 in lowering intraocular pressure (IOP)

Secondary Outcome Measures

To compare the safety and efficacy of DE-104 ophthalmic solution with placebo and 0.005% latanoprost.

Full Information

First Posted
March 27, 2008
Last Updated
November 1, 2011
Sponsor
Santen Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00650338
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, Placebo- and Active- Controlled, Parallel-group, Multi-center, Dose-response Trial of DE-104 Ophthalmic Solution in Subjects With Primary Open-angle Glaucoma or Ocular Hypertension
Study Type
Interventional

2. Study Status

Record Verification Date
November 2011
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
October 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Santen Inc.

4. Oversight

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

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
165 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
<described in intervention>
Arm Title
2
Arm Type
Experimental
Arm Description
<described in intervention>
Arm Title
3
Arm Type
Experimental
Arm Description
<described in intervention>
Arm Title
4
Arm Type
Placebo Comparator
Arm Description
<described in intervention>
Arm Title
5
Arm Type
Active Comparator
Arm Description
<described intervention>
Intervention Type
Drug
Intervention Name(s)
DE-104 ophthalmic solution, low concentration
Intervention Description
Topical ocular application
Intervention Type
Drug
Intervention Name(s)
DE-104 ophthalmic solution, medium concentration
Intervention Description
Topical ocular application
Intervention Type
Drug
Intervention Name(s)
DE-104 ophthalmic solution, high concentration
Intervention Description
Topical ocular application
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
placebo
Intervention Type
Drug
Intervention Name(s)
0.005% latanoprost
Intervention Description
Topical ocular application
Primary Outcome Measure Information:
Title
To investigate the dose-response relationship of DE-104 in lowering intraocular pressure (IOP)
Time Frame
28 days
Secondary Outcome Measure Information:
Title
To compare the safety and efficacy of DE-104 ophthalmic solution with placebo and 0.005% latanoprost.
Time Frame
35 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Provided signed, written informed consent. Diagnosed with primary open-angle glaucoma or ocular hypertension. 18 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. 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
Sall Research Medical Center
City
Artesia
State/Province
California
ZIP/Postal Code
90701
Country
United States
Facility Name
USC Department of Ophthalmology
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Wolstan Eye Associates
City
Torrance
State/Province
California
ZIP/Postal Code
90505
Country
United States
Facility Name
East Florida Eye Institute
City
Stuart
State/Province
Florida
ZIP/Postal Code
34994
Country
United States
Facility Name
Seidenberg Protzko Eye Associates
City
Bel Air
State/Province
Maryland
ZIP/Postal Code
21014
Country
United States
Facility Name
University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198-5540
Country
United States
Facility Name
Rochester Ophthalmological Group, PC
City
Rochester
State/Province
New York
ZIP/Postal Code
14618
Country
United States
Facility Name
Cornerstone Eye Care
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27262
Country
United States
Facility Name
Associated Glaucoma Consultants
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Keystone Research, Ltd.
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
David Shulman, MD P-A
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78209
Country
United States
Facility Name
Eye Clinics of South Texas
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78209
Country
United States
Facility Name
Medical Center Ophthalmology Associates
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240
Country
United States
Facility Name
Virginia Eye Consultants
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States

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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