DE-111 Ophthalmic Solution in Patients With Open Angle Glaucoma or Ocular Hypertension

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
Safety and IOP (intraocular pressure) lowering effect of DE-111 ophthalmic solution will be evaluated in open-angle glaucoma or ocular hypertension patients, in an open-label, multicenter study.

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

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Long-term Open-label Study of DE-111 Ophthalmic Solution in Patients With Open Angle Glaucoma or Ocular Hypertension -Phase 3-

Resource links provided by NLM:

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

Primary Outcome Measures:
  • Change From Baseline in IOP (Intraocular Pressure) at End of Study [ Time Frame: Treatment period: Week 0 (Baseline) and Week 52 (End of Study) ] [ Designated as safety issue: Yes ]

Enrollment: 148
Study Start Date: May 2011
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
DE-111 ophthalmic solution
Drug: DE-111 ophthalmic solution


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

Inclusion Criteria:

  • Diagnosed with 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: NCT01343082

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

No publications provided

Responsible Party: Santen Pharmaceutical Co., Ltd. Identifier: NCT01343082     History of Changes
Other Study ID Numbers: 01111006
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

Additional relevant MeSH terms:
Glaucoma, Open-Angle
Ocular Hypertension
Cardiovascular Diseases
Eye Diseases
Vascular Diseases
Ophthalmic Solutions
Pharmaceutical Solutions
Pharmacologic Actions
Therapeutic Uses processed this record on November 27, 2015