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NCT02348476 Clinical Trial

A Study of Simbrinza™ Therapy in Patients With Open-Angle Glaucoma or Ocular Hypertension

Ocular Hypertension Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02348476
Other study ID # GMA-SIM-14-024
Secondary ID
Status Completed
Phase N/A
First received January 22, 2015
Last updated September 17, 2015
Start date November 2014
Est. completion date April 2015

Study information
Verified date September 2015
Source Allergan
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

This study is a retrospective chart review to assess the tolerability and efficacy of treatment with Simbrinza™ used for patients with Open-Angle Glaucoma or Ocular Hypertension.

Recruitment information / eligibility
Status Completed
Enrollment 150
Est. completion date April 2015
Est. primary completion date April 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Participants treated with Simbrinza™ for Intra-Ocular Pressure (IOP) lowering in at least one eye

- Participants who had at least one-follow-up visit with tolerablity and efficacy data after Simbrinza™ treatment initiation.

Exclusion criteria:

- Active ocular disease other than glaucoma or ocular hypertension

- History of any intraocular surgery or glaucoma laser surgery within 3 months.

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

Intervention

Other:
• No Intervention
No study drug is administered in this study.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Allergan

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary The time to first glaucoma therapy escalation occurrence or discontinuation of Simbrinza® 2 Years No
Secondary The time to first glaucoma therapy escalation occurrence 2 Years No
Secondary The time(s) to additional glaucoma therapy escalation occurrence(s) 2 Years No
Secondary Specific AEs and SAEs occurring with a frequency of =5% 2 Years No
See also
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