The Diurnal and Nocturnal Effect of Simbrinza and Timolol on Intraocular Pressure and Ocular Perfusion Pressure

March 10, 2016 updated by: University of Colorado, Denver
The purpose of this research study is to hypothesize that Simbrinza will achieve a decrease in intraocular pressure and increase in ocular perfusion pressure throughout the diurnal and nocturnal periods. The primary aim of this study will be to determine the effects of Simbrinza at multiple intervals throughout a 24-hour period. The secondary aim will be to compare these to those of timolol.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

Intraocular pressure (IOP) is a major risk factor for the development of glaucoma. In addition, it is the only modifiable factor in the prevention and subsequent treatment of glaucomatous optic neuropathy. Most clinicians only have access to a single IOP measurement during a patient visit that may only occur once every four months. These snapshots in time are probably not adequate for the optimal management of glaucoma. Diurnal IOP curves can provide a better estimate of each patient's individual IOP variation throughout the day. However diurnal curves do not typically cover another crucial time, the nocturnal period. Glaucomatous eyes have been shown to have different IOP curves during the nocturnal period compared to healthy controls. In addition, different classes of glaucoma drugs have variable IOP lowering effects during the nocturnal hours compared to the diurnal/wake period. For example, the betablocker timolol was shown to lower IOP during daytime hours but failed to lower IOP during the nocturnal period in the habitual position. Similarly, the alpha-agonist brimonidine failed to lower IOP overnight after significantly lowering IOP during the diurnal period. On the other hand, the prostaglandin analogues, including latanoprost and travoprost, lowered IOP throughout the diurnal and nocturnal periods although nocturnal lowering appears less than the daytime hours. Therefore it is crucial to determine an accurate IOP curve for each form of medication during both wake and sleep hours.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Eye Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients diagnosed with Open angle glaucoma, Ocular hypertension,Pigment dispersion glaucoma, or Pseudoexfoliation glaucoma

Description

Inclusion Criteria:

  • Diagnosis of open angle glaucoma or ocular hypertension including pigment dispersion glaucoma and pseudoexfoliation glaucoma.
  • Age ≥ 18 years, of either gender, or any race/ethnicity

Exclusion Criteria:

  • Females who are currently pregnant or planning to become pregnant during the study period
  • Contraindications to beta blockers (see below)
  • Patients currently taking oral beta blocker therapy
  • Diagnosis of any other form of glaucoma other than open-angle
  • Schaffer angle grade < 2 in either eye by gonioscopy
  • Intraocular surgery within 6 months or laser within 3 months
  • Inability to safely discontinue all ocular medications for 6 weeks
  • Patients who smoke or have irregular daily sleep patterns
  • History of allergy or intolerance to topical carbonic anhydrase inhibitors, or alpha-agonists
  • Patients who have started or changed glucocorticoids therapy in the last 3 months
  • Patients who are currently using medical or recreational marijuana
  • Any use of a non-FDA approved medication for glaucoma in the last 3 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Group A-Simbinza
Patients in Group A will receive Simbrinza (brinzolamide) 1%/0.2%, with instruction for three times daily (every 8hours) administration of the medication in both eyes for a minimum of 4 weeks and a maximum of 8 weeks of medication therapy.
Group B-Timolol
Patients in Group B will receive Timolol 0.5%, with instructions for twice daily administration (every 12 hours) of the medication in both eyes for a minimum of 4 weeks and a maximum of 8 weeks of medication therapy.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Intraocular pressure Group A
Time Frame: 24 hours
The primary outcome measure will be the change in intraocular pressure and ocular perfusion pressure after 4 weeks of Simbrinza therapy at multiple time points throughout a 24-hour period.
24 hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Intraocular pressure Group B
Time Frame: 24 hours
The secondary outcome measure will be the change in intraocular pressure and ocular perfusion pressure after 4 weeks of timolol therapy at multiple time points throughout a 24-hour period, and how this compares to similar effects by Simbrinza.
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Colorado, Denver

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2014

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2016

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 13, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 13, 2014

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 17, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 14, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 10, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 14-0362
  • UL1TR001082 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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