ELAZOP Switching Study in Korea
This study has been completed.
Sponsor:
Alcon Research
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
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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:
Genetics Home Reference related topics:
early-onset glaucoma
MedlinePlus related topics:
Glaucoma
U.S. FDA Resources
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
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 | |
| St. Mary's Hospital, The Catholic University of Korea | |
| Seoul, Korea, Republic of, 150-703 | |
| Yonsei University Severance Hospital | |
| Seoul, Korea, Republic of, 120-752 | |
| Yonsei University Kangnam Severance Hospital | |
| Seoul, Korea, Republic of, 135-720 | |
| 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 | |
| Kim's Eye Hospital | |
| Seoul, Korea, Republic of, 150-034 | |
| Samsung Medical Center | |
| Seoul, Korea, Republic of, 135-710 | |
| 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 Ocular Hypertension Eye Diseases |
ClinicalTrials.gov processed this record on May 23, 2013