Ocular Hypertension Clinical Trial
Official title:
The Diurnal and Nocturnal Effect of Simbrinza and Timolol on Intraocular Pressure and Ocular Perfusion Pressure
Verified date | March 2016 |
Source | University of Colorado, Denver |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Observational |
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.
Status | Completed |
Enrollment | 60 |
Est. completion date | March 2016 |
Est. primary completion date | March 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
United States | University of Colorado Eye Center | Aurora | Colorado |
Lead Sponsor | Collaborator |
---|---|
University of Colorado, Denver |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
Secondary | 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 | No |
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