The Diurnal and Nocturnal Effect of Pilocarpine on Intraocular Pressure and Ocular Perfusion Pressure

Glaucoma, Open-angle Clinical Trial

Official title:

The Diurnal and Nocturnal Effect of Pilocarpine on Intraocular Pressure and Ocular Perfusion Pressure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02754570
• Other study ID #: 15-1972
• Secondary ID: UL1TR001082
• Status: Completed
• Phase: N/A
• Start date: July 2016
• Est. completion date: February 21, 2018

Study information

• Verified date: October 2019
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study will be to determine the effects of pilocarpine as an adjunct medication to latanoprost monotherapy at multiple intervals throughout a 24-hour period and compare these effects to latanoprost alone.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: February 21, 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

Inclusion Criteria:

• Current confirmed diagnosis of:

• open angle glaucoma, or

• ocular hypertension including pigment dispersion glaucoma, and

• pseudoexfoliation glaucoma.

• Current use of topical latanoprost once a day in both eyes for at least 6 weeks

• any race/ethnicity

Exclusion Criteria:

• Females who are currently pregnant or planning to become pregnant during the study period

• Diagnosis of any other form of glaucoma other than open-angle

• Intraocular pressure readings of <14mmHg in either eye when measured during routine office visit in the past 12 months.

• Schaffer angle grade < 2 in either eye by gonioscopy

• Intraocular surgery within 6 months or laser within 3 months

• History of retinal tear or detachment in either eye

• Active iritis in either eye as determined by most recent eye examination

• Patients who smoke or have irregular daily sleep patterns

• 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

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Hypertension
• Hypertension, Ocular
• Ocular Hypertension

Intervention

Drug:
• Pilocarpine
Pilocarpine will be administered 4 times in addition to latanoprost.

Locations

Country	Name	City	State
United States	University of Colorado Denver Eye Hospital	Denver	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Intraocular Pressure From Baseline at Visit 3	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 4 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. 8 diurnal readings and 4 nocturnal readings were averaged separately during both Visit 2 for the PGA Monotherapy and Visit 3 for Pilocarpine+PGA	Two 24-hour visits: Baseline/Visit 2; Up to week 4/Visit 3
Secondary	Change in Ocular Perfusion Pressure	Ocular perfusion pressure will calculated from the intraocular pressure and blood pressure measurements. At Baseline/Visit 2, 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 (Visit 3) will be performed. This time, a dose of pilocarpine 2% will be administered at 4 different times in addition to the latanoprost (PGA monotherapy). As before, intraocular pressure and blood pressure will be measured every 2 hours. 8 diurnal readings and 4 nocturnal readings were averaged separately during both Visit 2 for the PGA Monotherapy and Visit 3 for Pilocarpine+PGA	Two 24-hour visits: Baseline/Visit 2; Up to week 4/Visit 3