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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Santen Inc.
ClinicalTrials.gov Identifier:
NCT01279083
First received: January 14, 2011
Last updated: December 14, 2012
Last verified: December 2012
History of Changes
  Purpose

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


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Santen Inc.:

Primary Outcome Measures:
  • Intraocular pressure (IOP) [ Time Frame: 29 days ] [ Designated as safety issue: No ]
    Change from baseline in mean diurnal IOP


Secondary Outcome Measures:
  • Intraocular pressure (IOP) [ Time Frame: 29 days ] [ Designated as safety issue: No ]
    Percent change from baseline in mean diurnal IOP


Enrollment: 147
Study Start Date: January 2011
Study Completion Date: February 2012
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01279083

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

No publications provided

Responsible Party: Santen Inc.
ClinicalTrials.gov Identifier: NCT01279083     History of Changes
Other Study ID Numbers: 29-001
Study First Received: January 14, 2011
Last Updated: December 14, 2012
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on May 21, 2013