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Dose, Effects and Characteristics of Pilocarpine

Primary Purpose

Open-angle Glaucoma

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Pilocarpine Concentration
Pilocarpine Frequency
Sponsored by
Wills Eye
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Open-angle Glaucoma focused on measuring Pilocarpine, POAG, IOP, Concentration, Frequency, Primary open-angle glaucoma, Primary open-angle glaucoma suspect

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Primary open-angle glaucoma
  • Primary open-angle glaucoma suspect

Sites / Locations

  • Wills Eye Glaucoma Service

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Pilocarpine Concentration

Pilocarpine Frequency

Arm Description

Varying concentration 0.5 to 8% - 22 patients were examined regarding: visual acuity, iris color, pupil size, chamber angle, C/D ratio, visual field (VF), coefficient of aqueous outflow and Goldmann tonometry. After a one month washout period, pilocarpine was used 4 times daily, in concentrations from 0.5 to 8%. The amount of IOP change was compared with various clinical findings

Varying frequency, once to four times daily - 15 patients were included in a crossover study: IOP was checked daily for 3 days and for 9 hours on fourth day. Pilocarpine was started on day 5 once daily OD and BID OS; on day 9 once daily OD and QID OS; on day 12 QID OD and once daily OS; on day 16 once daily OD and QID OS; and on day 19 QID OD and once daily OS. No medications were used on days 23-25. IOP was measured on days 4, 8, 11, 15, 18, 22 and 25.

Outcomes

Primary Outcome Measures

Intraocular Pressure

Secondary Outcome Measures

Full Information

First Posted
December 5, 2008
Last Updated
November 20, 2016
Sponsor
Wills Eye
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1. Study Identification

Unique Protocol Identification Number
NCT00803803
Brief Title
Dose, Effects and Characteristics of Pilocarpine
Official Title
Dose, Effects and Characteristics of Pilocarpine
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
August 1978 (undefined)
Primary Completion Date
August 1979 (Actual)
Study Completion Date
December 1979 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wills Eye

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this investigation, in which pilocarpine was given in repeated doses, was to evaluate: Part I - the effects of different concentrations of pilocarpine hydrochloride on intraocular pressure. Part II -the effects on intraocular pressure of glaucomatous patients to pilocarpine 2% when given once, twice and four daily. In addition, we studied various attributes of the eye which may serve as indicators of responsiveness of individual patients to pilocarpine.
Detailed Description
In addition, we studied various attributes of the eye which may serve as indicators of responsiveness of individual patients to pilocarpine.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Open-angle Glaucoma
Keywords
Pilocarpine, POAG, IOP, Concentration, Frequency, Primary open-angle glaucoma, Primary open-angle glaucoma suspect

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
37 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pilocarpine Concentration
Arm Type
Experimental
Arm Description
Varying concentration 0.5 to 8% - 22 patients were examined regarding: visual acuity, iris color, pupil size, chamber angle, C/D ratio, visual field (VF), coefficient of aqueous outflow and Goldmann tonometry. After a one month washout period, pilocarpine was used 4 times daily, in concentrations from 0.5 to 8%. The amount of IOP change was compared with various clinical findings
Arm Title
Pilocarpine Frequency
Arm Type
Experimental
Arm Description
Varying frequency, once to four times daily - 15 patients were included in a crossover study: IOP was checked daily for 3 days and for 9 hours on fourth day. Pilocarpine was started on day 5 once daily OD and BID OS; on day 9 once daily OD and QID OS; on day 12 QID OD and once daily OS; on day 16 once daily OD and QID OS; and on day 19 QID OD and once daily OS. No medications were used on days 23-25. IOP was measured on days 4, 8, 11, 15, 18, 22 and 25.
Intervention Type
Drug
Intervention Name(s)
Pilocarpine Concentration
Intervention Description
Varying concentration 0.5 to 8%
Intervention Type
Drug
Intervention Name(s)
Pilocarpine Frequency
Intervention Description
1 to 4 times daily
Primary Outcome Measure Information:
Title
Intraocular Pressure
Time Frame
25 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Primary open-angle glaucoma Primary open-angle glaucoma suspect
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
George L Spaeth, MD
Organizational Affiliation
Wills Eye Glaucoma Service
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wills Eye Glaucoma Service
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Dose, Effects and Characteristics of Pilocarpine

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