The Diurnal and Nocturnal Effect of Pilocarpine on Intraocular Pressure and Ocular Perfusion Pressure
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|ClinicalTrials.gov Identifier: NCT02754570|
Recruitment Status : Recruiting
First Posted : April 28, 2016
Last Update Posted : July 19, 2017
|Condition or disease||Intervention/treatment||Phase|
|Glaucoma, Open-angle Hypertension, Ocular||Drug: Pilocarpine||Not Applicable|
This study plans to learn more about the effect of pilocarpine on intraocular pressure and ocular perfusion pressure for a full twenty-four hour period.
In this study, the investigators seek to better characterize the knowledge base of the intraocular pressure (IOP) lowering effects of pilocarpine in patients with open angle glaucoma or ocular hypertension who are currently taking latanoprost. The goal is to define the potential additive effect of pilocarpine throughout a 24-hour period, not only for IOP, but for ocular perfusion pressure (defined as 2/3[diastolicBP + 1/3(systolicBP - diastolicBP)] - IOP). These data will allow to expand current knowledge of the effects of pilocarpine and help determine if this medication has a useful role as an adjunctive treatment in glaucoma.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Diurnal and Nocturnal Effect of Pilocarpine on Intraocular Pressure and Ocular Perfusion Pressure|
|Study Start Date :||July 2016|
|Estimated Primary Completion Date :||March 2018|
|Estimated Study Completion Date :||May 2018|
U.S. FDA Resources
Experimental: Pilocarpine group
Subjects with open-angle glaucoma and ocular hypertension.
Pilocarpine will be administered 3 times in addition to latanoprost.
Other Name: Pilocarpine Hydrochloride
- Change in intraocular pressure [ Time Frame: 1 week - 8 weeks ]Subjects will be enrolled at the first visit. Patients already on latanoprost may proceed immediately with the second visit. Patients on a different prostaglandin analog medication will be switched to latanoprost for at least 6 weeks. At second visit, intraocular pressure and blood pressure will be measured every 2 hours for a 24-hour period. At any point over the next 4 weeks, another 24-hour visit will be performed. This time, a dose of pilocarpine 2% will be administered at 3 different times in addition to the latanoprost . As before, intraocular pressure and blood pressure will be measured every 2 hours. After visit 3, subjects will return to their prior treatment regimen. Change in the intraocular pressure from the second and the third visit will be determined.
- Change in ocular perfusion pressure [ Time Frame: 1 week - 8 weeks ]Ocular perfusion pressure will calculated from the intraocular pressure and blood pressure measurements.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02754570
|Contact: Mary Preston, COMTfirstname.lastname@example.org|
|United States, Colorado|
|University of Colorado Denver Eye Hospital||Recruiting|
|Denver, Colorado, United States, 80045|
|Contact: Mary Preston, COMT 720-848-2035 email@example.com|
|Contact: Deepika Sridhar, PhD 7208485050 firstname.lastname@example.org|
|Principal Investigator:||Leonard Seibold, MD||University of Colorado, Denver|