Safety and Efficacy Study of DE-104 Ophthalmic Solution to Treat Open-angle Glaucoma or Ocular Hypertension
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
1 other identifier
interventional
165
1 country
14
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Mar 2008
Shorter than P25 for phase_2
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2008
CompletedFirst Submitted
Initial submission to the registry
March 27, 2008
CompletedFirst Posted
Study publicly available on registry
April 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2008
CompletedNovember 3, 2011
November 1, 2011
6 months
March 27, 2008
November 1, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
To investigate the dose-response relationship of DE-104 in lowering intraocular pressure (IOP)
28 days
Secondary Outcomes (1)
To compare the safety and efficacy of DE-104 ophthalmic solution with placebo and 0.005% latanoprost.
35 days
Study Arms (5)
1
EXPERIMENTAL\<described in intervention\>
2
EXPERIMENTAL\<described in intervention\>
3
EXPERIMENTAL\<described in intervention\>
4
PLACEBO COMPARATOR\<described in intervention\>
5
ACTIVE COMPARATOR\<described intervention\>
Interventions
Eligibility Criteria
You may qualify if:
- Provided signed, written informed consent.
- Diagnosed with primary open-angle glaucoma or ocular hypertension.
- 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
- Santen Inc.lead
Study Sites (14)
Sall Research Medical Center
Artesia, California, 90701, United States
USC Department of Ophthalmology
Los Angeles, California, 90033, United States
Wolstan Eye Associates
Torrance, California, 90505, United States
East Florida Eye Institute
Stuart, Florida, 34994, United States
Seidenberg Protzko Eye Associates
Bel Air, Maryland, 21014, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198-5540, United States
Rochester Ophthalmological Group, PC
Rochester, New York, 14618, United States
Cornerstone Eye Care
High Point, North Carolina, 27262, United States
Associated Glaucoma Consultants
Philadelphia, Pennsylvania, 19107, United States
Keystone Research, Ltd.
Austin, Texas, 78731, United States
David Shulman, MD P-A
San Antonio, Texas, 78209, United States
Eye Clinics of South Texas
San Antonio, Texas, 78209, United States
Medical Center Ophthalmology Associates
San Antonio, Texas, 78240, United States
Virginia Eye Consultants
Norfolk, Virginia, 23507, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 27, 2008
First Posted
April 1, 2008
Study Start
March 1, 2008
Primary Completion
September 1, 2008
Study Completion
October 1, 2008
Last Updated
November 3, 2011
Record last verified: 2011-11