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ELAZOP Switching Study in Korea

Information source: Alcon Research
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Open Angle Glaucoma

Intervention: Elazop (Azarga) (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Alcon Research

Summary

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.

Clinical Details

Study design: Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Mean Intraocular Pressure (IOP) change from baseline at final visit.

Eligibility

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

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.

Locations and Contacts

Youngnam Univ. Hospital, Daegu 705-707, Korea, Republic of

Asan Medical Center, Seoul 138-706, Korea, Republic of

Kim's Eye Hospital, Seoul 150-034, Korea, Republic of

Samsung Medical Center, Seoul 135-710, Korea, Republic of

Seoul National University Hospital, Seoul 110-744, Korea, Republic of

Seoul St. Mary's Hospital, The Catholic University of Korea, Seoul 137-040, Korea, Republic of

St. Mary's Hospital, The Catholic University of Korea, Seoul 150-703, Korea, Republic of

Yonsei University Kangnam Severance Hospital, Seoul 135-720, Korea, Republic of

Yonsei University Severance Hospital, Seoul 120-752, Korea, Republic of

Seoul National University Bundang Hospital, Sungnam, Gyounggi 463-707, Korea, Republic of

Additional Information

Starting date: March 2010
Last updated: December 13, 2012

Page last updated: August 20, 2015

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