search
Back to results

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

Primary Purpose

Glaucoma, Open-angle, Hypertension, Ocular

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pilocarpine
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glaucoma, Open-angle focused on measuring Open-angle glaucoma, Ocular hypertension, Latanoprost, Pilocarpine

Eligibility Criteria

18 Years - 89 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Colorado Denver Eye Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Pilocarpine group

Arm Description

Subjects with open-angle glaucoma and ocular hypertension that are currently taking latanoprost

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
April 20, 2016
Last Updated
October 16, 2019
Sponsor
University of Colorado, Denver
search

1. Study Identification

Unique Protocol Identification Number
NCT02754570
Brief Title
The Diurnal and Nocturnal Effect of Pilocarpine on Intraocular Pressure and Ocular Perfusion Pressure
Official Title
The Diurnal and Nocturnal Effect of Pilocarpine on Intraocular Pressure and Ocular Perfusion Pressure
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
July 2016 (undefined)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
February 21, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma, Open-angle, Hypertension, Ocular
Keywords
Open-angle glaucoma, Ocular hypertension, Latanoprost, Pilocarpine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pilocarpine group
Arm Type
Experimental
Arm Description
Subjects with open-angle glaucoma and ocular hypertension that are currently taking latanoprost
Intervention Type
Drug
Intervention Name(s)
Pilocarpine
Other Intervention Name(s)
Pilocarpine Hydrochloride
Intervention Description
Pilocarpine will be administered 4 times in addition to latanoprost.
Primary Outcome Measure Information:
Title
Change in Intraocular Pressure From Baseline at Visit 3
Description
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
Time Frame
Two 24-hour visits: Baseline/Visit 2; Up to week 4/Visit 3
Secondary Outcome Measure Information:
Title
Change in Ocular Perfusion Pressure
Description
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
Time Frame
Two 24-hour visits: Baseline/Visit 2; Up to week 4/Visit 3

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leonard Seibold, MD
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado Denver Eye Hospital
City
Denver
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs