Expired Study
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Philadelphia, Pennsylvania 19107


Purpose:

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.


Study summary:

In addition, we studied various attributes of the eye which may serve as indicators of responsiveness of individual patients to pilocarpine.


Criteria:

Inclusion Criteria: - Primary open-angle glaucoma - Primary open-angle glaucoma suspect


Study is Available At:


Original ID:

08-914E


NCT ID:

NCT00803803


Secondary ID:


Study Acronym:


Brief Title:

Dose, Effects and Characteristics of Pilocarpine


Official Title:

Dose, Effects and Characteristics of Pilocarpine


Overall Status:

Completed


Study Phase:

Phase 4


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

90 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Wills Eye


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Non-Randomized, Endpoint Classificatio


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

37


Enrollment Type:

Actual


Overall Contact Information

Official Name:George L Spaeth, MD
Principal Investigator
Wills Eye Glaucoma Service

Study Dates

Start Date:August 1978
Completion Date:December 1979
Completion Type:Actual
Primary Completion Date:August 1979
Primary Completion Type:Actual
Verification Date:November 2016
Last Changed Date:November 20, 2016
First Received Date:December 5, 2008

Study Outcomes

Outcome Type:Primary Outcome
Measure:Intraocular Pressure
Time Frame:25 days
Safety Issues:True

Study Interventions

Intervention Type:Drug
Name:Pilocarpine Concentration
Description:Varying concentration 0.5 to 8%
Arm Name:Pilocarpine Concentration
Intervention Type:Drug
Name:Pilocarpine Frequency
Description:1 to 4 times daily
Arm Name:Pilocarpine Frequency

Study Arms

Study Arm Type:Experimental
Arm Name:Pilocarpine Frequency
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.
Study Arm Type:Experimental
Arm Name:Pilocarpine Concentration
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

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Wills Eye

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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