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

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: Completed
• Conditions: Ocular Hypertension; Open Angle Glaucoma; Pseudoexfoliation Glaucoma; Pigment Dispersion Syndrome

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: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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

Outcome Measure	Measure Description	Time Frame
Intraocular pressure Group A	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

Outcome Measure	Measure Description	Time Frame
Intraocular pressure Group B	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

• Sponsor: University of Colorado, Denver

Study record dates

Study Major Dates

• Study Start: August 1, 2014
• Primary Completion (ACTUAL): March 1, 2016
• Study Completion (ACTUAL): March 1, 2016

Study Registration Dates

• First Submitted: June 13, 2014
• First Submitted That Met QC Criteria: June 13, 2014
• First Posted (ESTIMATE): June 17, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): March 14, 2016
• Last Update Submitted That Met QC Criteria: March 10, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Uveal Diseases; Iris Diseases; Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Exfoliation Syndrome
• Other Study ID Numbers: 14-0362; UL1TR001082 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO