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ELAZOP Switching Study in Korea

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01055366
First Posted: January 25, 2010
Last Update Posted: December 17, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Alcon Research
  Purpose
The purpose of this study is to assess the safety and efficacy of switching to ELAZOP from prior pharmacotherapy in patients with open-angled glaucoma.

Condition Intervention Phase
Open Angle Glaucoma Drug: Elazop (Azarga) Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Mean Intraocular Pressure (IOP) change from baseline at final visit. [ Time Frame: 12 weeks after treatment ]

Enrollment: 96
Study Start Date: March 2010
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Elazop (Azarga)
Elazop Treatment arm
Drug: Elazop (Azarga)
Administer one drop of ELAZOP in treated eye(s) twice a day for up to 12 weeks

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years of age or older.
  • Clinical diagnosis of ocular hypertension, primary open-angle or pigment dispersion glaucoma in both eyes.
  • Must be on a stable regimen of Intraocular Pressure (IOP) lowering medication (i.e., either a single therapeutic agent or two separate ocular hypotensive agents) for at least one month prior to the Screening Visit.
  • Must have IOP considered to be safe (in the opinion of the investigator), in both eyes, in such a way that should assure clinical stability of vision and the optic nerve throughout the study period.
  • Must be willing to discontinue the use of all other ocular hypotensive medications prior to receiving the study medication for the entire course of the study.
  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • Known medical history of allergy, hypersensitivity, or poor tolerance to any component of the preparations to be used in the study that is deemed clinically significant in the opinion of the Principal Investigator.
  • Intraocular conventional surgery or laser surgery in either eye less than three months prior to the Screening visit.
  • History of ocular herpes simplex.
  • Pregnant or lactating.
  • Participation in any other investigational study within 30 days of Screening visit.
  • Other protocol-defined exclusion criteria may apply.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01055366


Locations
Korea, Republic of
Seoul National University Bundang Hospital
Sungnam, Gyounggi, Korea, Republic of, 463-707
Youngnam Univ. Hospital
Daegu, Korea, Republic of, 705-707
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Yonsei University Severance Hospital
Seoul, Korea, Republic of, 120-752
Samsung Medical Center
Seoul, Korea, Republic of, 135-710
Yonsei University Kangnam Severance Hospital
Seoul, Korea, Republic of, 135-720
Seoul St. Mary's Hospital, The Catholic University of Korea
Seoul, Korea, Republic of, 137-040
Asan Medical Center
Seoul, Korea, Republic of, 138-706
Kim's Eye Hospital
Seoul, Korea, Republic of, 150-034
St. Mary's Hospital, The Catholic University of Korea
Seoul, Korea, Republic of, 150-703
Sponsors and Collaborators
Alcon Research
  More Information

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01055366     History of Changes
Other Study ID Numbers: RM-09-06
First Submitted: January 22, 2010
First Posted: January 25, 2010
Last Update Posted: December 17, 2012
Last Verified: May 2012

Keywords provided by Alcon Research:
Open angle glaucoma
OAG
Elazop
Azarga
Brinzolamide/Timolol combination

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