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ELAZOP Switching Study in Korea

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01055366
First received: January 22, 2010
Last updated: December 13, 2012
Last verified: May 2012
  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: 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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
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 ClinicalTrials.gov identifier: 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
Samsung Medical Center
Seoul, Korea, Republic of, 135-710
Kim's Eye Hospital
Seoul, Korea, Republic of, 150-034
Yonsei University Severance Hospital
Seoul, Korea, Republic of, 120-752
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Seoul St. Mary's Hospital, The Catholic University of Korea
Seoul, Korea, Republic of, 137-040
St. Mary's Hospital, The Catholic University of Korea
Seoul, Korea, Republic of, 150-703
Yonsei University Kangnam Severance Hospital
Seoul, Korea, Republic of, 135-720
Asan Medical Center
Seoul, Korea, Republic of, 138-706
Sponsors and Collaborators
Alcon Research
  More Information

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01055366     History of Changes
Other Study ID Numbers: RM-09-06
Study First Received: January 22, 2010
Last Updated: December 13, 2012
Health Authority: Korea: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on November 25, 2014