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

This study has been completed.
Sponsor:
Information provided by:
Santen Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01343082
First received: April 24, 2011
Last updated: February 6, 2013
Last verified: February 2013
History of Changes
  Purpose

Safety and IOP 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
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:

U.S. FDA Resources

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

Arms Assigned Interventions
Experimental: 1
DE-111 ophthalmic solution
 Drug: DE-111 ophthalmic solution

  Eligibility

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

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01343082

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

No publications provided

ClinicalTrials.gov Identifier: NCT01343082     History of Changes
Other Study ID Numbers: 01111006
Study First Received: April 24, 2011
Last Updated: February 6, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare

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

ClinicalTrials.gov processed this record on May 16, 2013