DE-111 Against Timolol Ophthalmic Solution 0.5%

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

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%


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

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
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 identifier: NCT01342094

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

No publications provided 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, Open-Angle
Ocular Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases
Pharmaceutical Solutions
Ophthalmic Solutions
Therapeutic Uses
Pharmacologic Actions
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Cardiovascular Agents
Antihypertensive Agents processed this record on September 18, 2014