DE-111 Against Timolol Ophthalmic Solution 0.5%

This study has been completed.
Information provided by (Responsible Party):
Santen Pharmaceutical Co., Ltd. Identifier:
First received: April 24, 2011
Last updated: May 19, 2015
Last verified: May 2015

DE-111 ophthalmic solution will be evaluated for superiority in comparison with Timolol ophthalmic solution 0.5%, in IOP(intraocular pressure ) -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
Study Design: Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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.:

Primary Outcome Measures:
  • Change From Baseline in Mean Diurnal IOP (Intraocular Pressure) at End of Study [ Time Frame: Week 0(Baseline) and Week 4(End of Study) ] [ Designated as safety issue: Yes ]
    Mean diurnal IOP (intraocular pressure) was calculated as an average of IOP (intraocular pressure) at 9:30 (pre-dose), 11:30 and 17:30.

Enrollment: 166
Study Start Date: May 2011
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: DE-111 ophthalmic solution Drug: DE-111 ophthalmic solution
DE-111 ophthalmic solution (one drop at a time, once daily) and Placebo ophthalmic solution (one drop at a time, BID) in both eyes.
Active Comparator: Timolol ophthalmic solution 0.5% Drug: Timolol ophthalmic solution 0.5%
Timolol ophthalmic solution 0.5% (one drop at a time, BID) and Placebo ophthalmic solution (one drop at a time, once daily) in both eyes.


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
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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

Responsible Party: Santen Pharmaceutical Co., Ltd. Identifier: NCT01342094     History of Changes
Other Study ID Numbers: 01111005
Study First Received: April 24, 2011
Results First Received: April 28, 2015
Last Updated: May 19, 2015
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
Cardiovascular Diseases
Eye Diseases
Vascular Diseases
Ophthalmic Solutions
Pharmaceutical Solutions
Adrenergic Agents
Adrenergic Antagonists
Adrenergic beta-Antagonists
Anti-Arrhythmia Agents
Antihypertensive Agents
Cardiovascular Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses processed this record on June 29, 2015