Clinical trial NCT00650338: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Open-Angle Glaucoma
Ocular Hypertension
Lead sponsor: Santen Inc.
Sponsor class: INDUSTRY
First posted: 2008-04-01
Enrollment: 165
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: To investigate the dose-response relationship of DE-104 in lowering intraocular pressure (IOP)
timeFrame: 28 days
Secondary outcomes:
measure: To compare the safety and efficacy of DE-104 ophthalmic solution with placebo and 0.005% latanoprost.
timeFrame: 35 days
Other outcomes:
Locations:
city: Artesia
country: United States
facility: Sall Research Medical Center
state: California
city: Los Angeles
country: United States
facility: USC Department of Ophthalmology
state: California
city: Torrance
country: United States
facility: Wolstan Eye Associates
state: California
city: Stuart
country: United States
facility: East Florida Eye Institute
state: Florida
city: Bel Air
country: United States
facility: Seidenberg Protzko Eye Associates
state: Maryland
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: Rochester
country: United States
facility: Rochester Ophthalmological Group, PC
state: New York
city: High Point
country: United States
facility: Cornerstone Eye Care
state: North Carolina
city: Philadelphia
country: United States
facility: Associated Glaucoma Consultants
state: Pennsylvania
city: Austin
country: United States
facility: Keystone Research, Ltd.
state: Texas
city: San Antonio
country: United States
facility: David Shulman, MD P-A
state: Texas
city: San Antonio
country: United States
facility: Eye Clinics of South Texas
state: Texas
city: San Antonio
country: United States
facility: Medical Center Ophthalmology Associates
state: Texas
city: Norfolk
country: United States
facility: Virginia Eye Consultants
state: Virginia
Study officials:
References: