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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Santen Inc.
ClinicalTrials.gov Identifier:
NCT00650338
First received: March 27, 2008
Last updated: November 1, 2011
Last verified: November 2011
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


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
Experimental: 1
<described in intervention>
Drug: DE-104 ophthalmic solution, low concentration
Topical ocular application
Experimental: 2
<described in intervention>
Drug: DE-104 ophthalmic solution, medium concentration
Topical ocular application
Experimental: 3
<described in intervention>
Drug: DE-104 ophthalmic solution, high concentration
Topical ocular application
Placebo Comparator: 4
<described in intervention>
Drug: Placebo
placebo
Active Comparator: 5
<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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, California
Sall Research Medical Center
Artesia, California, United States, 90701
USC Department of Ophthalmology
Los Angeles, California, United States, 90033
Wolstan Eye Associates
Torrance, California, United States, 90505
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
Keystone Research, Ltd.
Austin, Texas, United States, 78731
David Shulman, MD P-A
San Antonio, Texas, United States, 78209
Eye Clinics of South Texas
San Antonio, Texas, United States, 78209
Medical Center Ophthalmology Associates
San Antonio, Texas, United States, 78240
United States, Virginia
Virginia Eye Consultants
Norfolk, Virginia, United States, 23507
Sponsors and Collaborators
Santen Inc.
  More Information

No publications provided

Responsible Party: Santen Inc.
ClinicalTrials.gov Identifier: NCT00650338     History of Changes
Other Study ID Numbers: 27-002
Study First Received: March 27, 2008
Last Updated: November 1, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle
Hypertension
Ocular Hypertension
Cardiovascular Diseases
Eye Diseases
Vascular Diseases
Ophthalmic Solutions
Pharmaceutical Solutions
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014