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
  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:


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
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: 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 July 26, 2014