NCT00803803

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Aug 1978

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 1978

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 1979

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 1979

Completed
29 years until next milestone

First Submitted

Initial submission to the registry

December 5, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 8, 2008

Completed
Last Updated

November 22, 2016

Status Verified

November 1, 2016

Enrollment Period

1 year

First QC Date

December 5, 2008

Last Update Submit

November 20, 2016

Conditions

Open-angle Glaucoma

Keywords

PilocarpinePOAGIOPConcentrationFrequencyPrimary open-angle glaucomaPrimary open-angle glaucoma suspect

Outcome Measures

Primary Outcomes (1)

  • Intraocular Pressure

    25 days

Study Arms (2)

Pilocarpine Concentration

EXPERIMENTAL

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

Drug: Pilocarpine Concentration

Pilocarpine Frequency

EXPERIMENTAL

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.

Drug: Pilocarpine Frequency

Interventions

Pilocarpine ConcentrationDRUG

Varying concentration 0.5 to 8%

Pilocarpine Concentration
Pilocarpine FrequencyDRUG

1 to 4 times daily

Pilocarpine Frequency

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wills Eye Glaucoma Service

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Glaucoma, Open-Angle

Condition Hierarchy (Ancestors)

GlaucomaOcular HypertensionEye Diseases

Study Officials

  • George L Spaeth, MD

    Wills Eye Glaucoma Service

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending Surgeon

Study Record Dates

First Submitted

December 5, 2008

First Posted

December 8, 2008

Study Start

August 1, 1978

Primary Completion

August 1, 1979

Study Completion

December 1, 1979

Last Updated

November 22, 2016

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)