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

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ClinicalTrials.gov Identifier: NCT00868894
Recruitment Status : Completed
First Posted : March 25, 2009
Last Update Posted : November 3, 2011
Sponsor:
Information provided by (Responsible Party):
Santen Inc.

Brief Summary:
To investigate safety, efficacy, and the dose-response relationship of DE-104 in lowering intraocular pressure in Japanese and Non-Japanese subjects with primary open-angle glaucoma or ocular hypertension.

Condition or disease Intervention/treatment Phase
Open-Angle Glaucoma Ocular Hypertension Drug: DE-104 medium concentration Drug: DE-104 high concentration Drug: Placebo Drug: 0.005% latanoprost Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 49 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-masked, Placebo- and Active-controlled, Multi-Center, Dose Escalation Trial of DE-104 Ophthalmic Solution in Japanese and Non-Japanese Subjects With Primary Open-angle Glaucoma or Ocular Hypertension
Study Start Date : March 2009
Actual Primary Completion Date : May 2010
Actual Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Care Glaucoma
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1 Drug: DE-104 medium concentration
Topical ocular application
Experimental: 2 Drug: DE-104 high concentration
Topical ocular application
Placebo Comparator: 3 Drug: Placebo
Topical ocular application
Active Comparator: 4 Drug: 0.005% latanoprost
Topical ocular application



Primary Outcome Measures :
  1. To compare the safety and efficacy of two concentrations of DE-104 ophthalmic solution with placebo and 0.005% latanoprost in Japanese and Non-Japanese subjects with primary open-angle glaucoma or ocular hypertension. [ Time Frame: 15 days ]

Secondary Outcome Measures :
  1. To investigate the dose-response relationship of DE-104 in lowering intraocular pressure in Japanese and Non-Japanese subjects with primary open-angle glaucoma or ocular hypertension. [ Time Frame: 15 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Provided signed, written informed consent.
  • 18 years of age and older.
  • Diagnosed with primary open-angle glaucoma or ocular hypertension.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00868894


Locations
United States, California
Artesia, California, United States, 90701
Pasadena, California, United States, 91105
San Francisco, California, United States, 94102
United States, Hawaii
Honolulu, Hawaii, United States, 96814
Kailua, Hawaii, United States, 96734
United States, New York
New York, New York, United States, 10016
Sponsors and Collaborators
Santen Inc.

Responsible Party: Santen Inc.
ClinicalTrials.gov Identifier: NCT00868894     History of Changes
Other Study ID Numbers: 27-003
First Posted: March 25, 2009    Key Record Dates
Last Update Posted: November 3, 2011
Last Verified: November 2011

Additional relevant MeSH terms:
Hypertension
Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases
Ophthalmic Solutions
Latanoprost
Pharmaceutical Solutions
Antihypertensive Agents