Open-Angle GlaucomaNCT02348476
A Study of Simbrinza™ Therapy in Patients With Open-Angle Glaucoma or Ocular Hypertension
An observational study of Open-Angle Glaucoma and Ocular Hypertension, run by Allergan at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Open-Angle Glaucoma, Ocular Hypertension
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2014to Apr 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with Open-Angle Glaucoma or Ocular Hypertension treated in clinical practice.
Who may be able to join
- 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.
Who cannot join
- Active ocular disease other than glaucoma or ocular hypertension
- History of any intraocular surgery or glaucoma laser surgery within 3 months.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Open-Angle Glaucoma, Ocular Hypertension
- Being tested
- No Intervention
- Medical subject headings
- Glaucoma, Open-Angle, Ocular Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No InterventionOther
No study drug is administered in this study.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
The time to first glaucoma therapy escalation occurrence or discontinuation of Simbrinza®
Measured: 2 Years
Secondary outcomes (3)
The time to first glaucoma therapy escalation occurrence
Measured: 2 Years
The time(s) to additional glaucoma therapy escalation occurrence(s)
Measured: 2 Years
Specific AEs and SAEs occurring with a frequency of ≥5%
Measured: 2 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2015 (estimated)
- Study startNov 2014
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Open-Angle GlaucomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allergan
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Allergan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02348476
- Sponsor's protocol ID
- GMA-SIM-14-024
- Status last verified
- Sep 2015
- First submitted
- 22 Jan 2015
- Last updated
- 21 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Simbrinza™ Therapy in Patients With Open-Angle Glaucoma or Ocular Hypertension
- ClinicalTrials.gov ID
- NCT02348476
- Acronym / sponsor ID
- GMA-SIM-14-024
- Conditions
- Open-Angle Glaucoma, Ocular Hypertension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- Nov 2014
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 28 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Simbrinza™ | – | Other: No InterventionPatients treated with Simbrinza™ (brinzolamide 1%/brimonidine 0.2%) as standard of care in clinical practice. No study drug is administered in this study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Open-Angle Glaucoma or Ocular Hypertension treated in clinical practice.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- Active ocular disease other than glaucoma or ocular hypertension
- History of any intraocular surgery or glaucoma laser surgery within 3 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No InterventionNo study drug is administered in this study. | Other | Simbrinza™ |
Primary outcome
The time to first glaucoma therapy escalation occurrence or discontinuation of Simbrinza®
Time frame: 2 Years
3 secondary outcomes
The time to first glaucoma therapy escalation occurrence
Time frame: 2 Years
The time(s) to additional glaucoma therapy escalation occurrence(s)
Time frame: 2 Years
Specific AEs and SAEs occurring with a frequency of ≥5%
Time frame: 2 Years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Allergan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Open-Angle Glaucoma and Ocular Hypertension, run by Allergan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The time to first glaucoma therapy escalation occurrence or discontinuation of Simbrinza® (time frame: 2 Years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2015.