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Safety and Efficacy Trial to Treat Open-Angle Glaucoma or Ocular Hypertension

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01279083
Recruitment Status : Completed
First Posted : January 19, 2011
Last Update Posted : December 17, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
To investigate the safety and efficacy of DE-112 in lowering intraocular pressure in subjects with primary open-angle glaucoma or ocular hypertension.

Condition or disease Intervention/treatment Phase
Open-angle Glaucoma Ocular Hypertension Drug: DE-112 Drug: DE-112 Vehicle Solution Drug: Timolol Maleate Solution Phase 1 Phase 2

Detailed Description:

This study will be conducted in two stages. Stage One is an open-label, adaptive dose-selection, safety and efficacy trial of up to four concentrations of DE-112 ophthalmic solution enrolling a total of 24 subjects.

Stage Two of the study is a randomized, double-masked, placebo- and active-controlled, parallel-group, multi-center trial comparing the efficacy and safety of two concentrations of DE-112 ophthalmic solution with placebo and timolol enrolling a total of 120 subjects.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 147 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase I/II Dose Escalation Safety and Efficacy Trial of DE-112 Ophthalmic Solution in Subjects With Primary Open-Angle Glaucoma or Ocular Hypertension
Study Start Date : January 2011
Primary Completion Date : November 2011
Study Completion Date : February 2012

Resource links provided by the National Library of Medicine

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

Arms and Interventions

Arm Intervention/treatment
Experimental: Concentration 1 Drug: DE-112
Topical ocular solution
Experimental: Concentration 2 Drug: DE-112
Topical ocular solution
Experimental: Concentration 3 Drug: DE-112
Topical ocular solution
Experimental: Concentration 4 Drug: DE-112
Topical ocular solution
Placebo Comparator: Vehicle Solution Drug: DE-112 Vehicle Solution
Topical ocular solution
Active Comparator: Timolol Maleate Ophthalmic Solution Drug: Timolol Maleate Solution
Topical ocular solution


Outcome Measures

Primary Outcome Measures :
  1. Intraocular pressure (IOP) [ Time Frame: 29 days ]
    Change from baseline in mean diurnal IOP


Secondary Outcome Measures :
  1. Intraocular pressure (IOP) [ Time Frame: 29 days ]
    Percent change from baseline in mean diurnal IOP


Eligibility Criteria

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:

  • Provide signed, written informed consent
  • 18 yeas of age and older
  • Diagnosed with primary open-angle glaucoma or ocular hypertension
  • Female subject of childbearing potential must utilize reliable contraceptive throughout the study and have a negative urine pregnancy test prior to enrollment into this study
  • Meet specific Visit 2, Day 0 (Baseline)criteria at baseline

Exclusion Criteria:

  • Females who are pregnant, nursing or planning a pregnancy
  • Presence of any abnormality or significant illness that could be expected to interfere with the study.
Contacts and Locations

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): NCT01279083


Locations
United States, Texas
Austin, Texas, United States, 78731
San Antonio, Texas, United States, 78207
Sponsors and Collaborators
Santen Inc.
More Information

Responsible Party: Santen Inc.
ClinicalTrials.gov Identifier: NCT01279083     History of Changes
Other Study ID Numbers: 29-001
First Posted: January 19, 2011    Key Record Dates
Last Update Posted: December 17, 2012
Last Verified: December 2012

Additional relevant MeSH terms:
Hypertension
Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases
Pharmaceutical Solutions
Ophthalmic Solutions
Timolol
Maleic acid
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents
Enzyme Inhibitors