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NCT02003534 Clinical Trial

A Study of 0.15% Brimonidine Tartrate in Patients With Primary Open Angle Glaucoma and Ocular Hypertension

Ocular Hypertension Clinical Trial

— APOTUS  

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02003534
Other study ID # CN-BRI-1002
Secondary ID
Status Completed
Phase Phase 4
First received December 2, 2013
Last updated June 24, 2014
Start date July 2010
Est. completion date February 2013

Study information
Verified date June 2014
Source Allergan
Contact n/a
Is FDA regulated No
Health authority China: Ethics Committee
Study type Interventional

Clinical Trial Summary

This study will evaluate 0.15% brimonidine tartrate in patients with primary open angle glaucoma and ocular hypertension.

Recruitment information / eligibility
Status Completed
Enrollment 376
Est. completion date February 2013
Est. primary completion date February 2013
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- Diagnosis of open-angle glaucoma or ocular hypertension

Exclusion Criteria:

- Used Alphagan® in previous 3 months

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• 0.15% Brimonidine Tartrate
0.15% Brimonidine Tartrate (Alphagan® P) 1 drop in the affected eye 3 times daily for 3 months.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Allergan

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change From Baseline in Intraocular Pressure (IOP) in the Study Eye IOP is a measurement of the fluid pressure inside the eye. A negative number change from baseline indicates a reduction in IOP (improvement), and a positive number change from baseline indicates an increase (worsening). Baseline, Month 3 No
See also
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