NCT02348476

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2014

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 22, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 28, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

September 21, 2015

Status Verified

September 1, 2015

Enrollment Period

5 months

First QC Date

January 22, 2015

Last Update Submit

September 17, 2015

Conditions

Open-Angle GlaucomaOcular Hypertension

Outcome Measures

Primary Outcomes (1)

  • The time to first glaucoma therapy escalation occurrence or discontinuation of Simbrinza®

    2 Years

Secondary Outcomes (3)

  • The time to first glaucoma therapy escalation occurrence

    2 Years

  • The time(s) to additional glaucoma therapy escalation occurrence(s)

    2 Years

  • Specific AEs and SAEs occurring with a frequency of ≥5%

    2 Years

Study Arms (1)

Simbrinza™

Patients treated with Simbrinza™ (brinzolamide 1%/brimonidine 0.2%) as standard of care in clinical practice. No study drug is administered in this study.

Other: No Intervention

Interventions

No InterventionOTHER

No study drug is administered in this study.

Simbrinza™

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with Open-Angle Glaucoma or Ocular Hypertension treated in clinical practice.

You may qualify if:

  • 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.

You may not qualify if:

  • Active ocular disease other than glaucoma or ocular hypertension
  • History of any intraocular surgery or glaucoma laser surgery within 3 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Wheaton, Illinois, United States

Location

MeSH Terms

Conditions

Glaucoma, Open-AngleOcular Hypertension

Condition Hierarchy (Ancestors)

GlaucomaEye Diseases

Study Officials

  • Medical Director

    Allergan

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 22, 2015

First Posted

January 28, 2015

Study Start

November 1, 2014

Primary Completion

April 1, 2015

Study Completion

April 1, 2015

Last Updated

September 21, 2015

Record last verified: 2015-09

Locations

US(1)