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

Sponsored by:	Santen Inc.
Information provided by:	Santen Inc.
ClinicalTrials.gov Identifier:	NCT00650338

Purpose

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

Condition	Intervention	Phase
Open-Angle Glaucoma Ocular Hypertension	Drug: DE-104 ophthalmic solution, low concentration Drug: DE-104 ophthalmic solution, medium concentration Drug: DE-104 ophthalmic solution, high concentration Drug: Placebo Drug: 0.005% latanoprost	Phase II

Genetics Home Reference related topics: early-onset glaucoma

MedlinePlus related topics: Glaucoma High Blood Pressure

Drug Information available for: Latanoprost

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment
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

Further study details as provided by Santen Inc.:

Primary Outcome Measures:

To investigate the dose-response relationship of DE-104 in lowering intraocular pressure (IOP) [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To compare the safety and efficacy of DE-104 ophthalmic solution with placebo and 0.005% latanoprost. [ Time Frame: 35 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	165
Study Start Date:	March 2008
Study Completion Date:	October 2008
Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental <described in intervention>	Drug: DE-104 ophthalmic solution, low concentration Topical ocular application
2: Experimental <described in intervention>	Drug: DE-104 ophthalmic solution, medium concentration Topical ocular application
3: Experimental <described in intervention>	Drug: DE-104 ophthalmic solution, high concentration Topical ocular application
4: Placebo Comparator <described in intervention>	Drug: Placebo placebo
5: Active Comparator <described intervention>	Drug: 0.005% latanoprost Topical ocular application

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00650338

Locations

United States, California
Sall Research Medical Center
Artesia, California, United States, 90701
Wolstan Eye Associates
Torrance, California, United States, 90505
USC Department of Ophthalmology
Los Angeles, California, United States, 90033
United States, Florida
East Florida Eye Institute
Stuart, Florida, United States, 34994
United States, Maryland
Seidenberg Protzko Eye Associates
Bel Air, Maryland, United States, 21014
United States, Nebraska
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198-5540
United States, New York
Rochester Ophthalmological Group, PC
Rochester, New York, United States, 14618
United States, North Carolina
Cornerstone Eye Care
High Point, North Carolina, United States, 27262
United States, Pennsylvania
Associated Glaucoma Consultants
Philadelphia, Pennsylvania, United States, 19107
United States, Texas
Medical Center Ophthalmology Associates
San Antonio, Texas, United States, 78240
Eye Clinics of South Texas
San Antonio, Texas, United States, 78209
David Shulman, MD P-A
San Antonio, Texas, United States, 78209
Keystone Research, Ltd.
Austin, Texas, United States, 78731
United States, Virginia
Virginia Eye Consultants
Norfolk, Virginia, United States, 23507

Sponsors and Collaborators

Santen Inc.

More Information

Responsible Party:	Santen Incorporated ( Susan Schneider/Vice President, Clinical Affairs )
Study ID Numbers:	27-002
Study First Received:	March 27, 2008
Last Updated:	December 19, 2008
ClinicalTrials.gov Identifier:	NCT00650338
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Glaucoma
Eye Diseases
Glaucoma, Open-Angle
Vascular Diseases

Latanoprost
Hypertension
Ocular Hypertension

Additional relevant MeSH terms:

Therapeutic Uses
Cardiovascular Diseases
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009