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

Completed

Conditions studied: Open Angle Glaucoma, Ocular Hypertension, Pigment Dispersion Syndrome, Pseudoexfoliation Glaucoma

In brief

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.

Key facts

Study ID

NCT02165631

Run by

University of Colorado, Denver

People needed

60

Starts

2014-08-01

Expected to finish

2016-03-01

Last updated by the study team

2016-03-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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