DE-111 Against Timolol Ophthalmic Solution 0.5%

This study has been completed.
Sponsor:
Information provided by:
Santen Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01342094
First received: April 24, 2011
Last updated: July 26, 2012
Last verified: July 2012
  Purpose

DE-111 ophthalmic solution will be evaluated for superiority in comparison with Timolol ophthalmic solution 0.5%, in IOP-lowering effect in primary open-angle glaucoma or ocular hypertension patients, in a multicenter, randomized, double-masked, parallel-group comparison study. Safety will be compared and evaluated as well.


Condition Intervention Phase
Open Angle Glaucoma
Ocular Hypertension
Drug: DE-111 ophthalmic solution
Drug: Timolol ophthalmic solution 0.5%
Phase 3

Study Type: Interventional
Official Title: A Double-masked Study of DE-111 Ophthalmic Solution Versus Timolol Ophthalmic Solution 0.5% in Patients With Primary Open Angle Glaucoma or Ocular Hypertension - Phase 3, Confirmatory Study -

Resource links provided by NLM:


Further study details as provided by Santen Pharmaceutical Co., Ltd.:

Arms Assigned Interventions
Experimental: DE-111 ophthalmic solution Drug: DE-111 ophthalmic solution
Active Comparator: Timolol ophthalmic solution 0.5% Drug: Timolol ophthalmic solution 0.5%

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Criteria

Inclusion Criteria:

  • Diagnosed with primary open angle glaucoma or ocular hypertension
  • Provided signed, written informed consent
  • 20 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01342094

Locations
Japan
Santen study sites
Osaka, Japan
Sponsors and Collaborators
Santen Pharmaceutical Co., Ltd.
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT01342094     History of Changes
Other Study ID Numbers: 01111005
Study First Received: April 24, 2011
Last Updated: July 26, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Santen Pharmaceutical Co., Ltd.:
Primary open angle glaucoma or ocular hypertension

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle
Hypertension
Ocular Hypertension
Eye Diseases
Vascular Diseases
Cardiovascular Diseases
Timolol
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

ClinicalTrials.gov processed this record on April 21, 2014