Dose, Effects and Characteristics of Pilocarpine

NCT ID: NCT00803803

Last Updated: 2016-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

1978-08-31

Study Completion Date

1979-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Open-angle Glaucoma

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Pilocarpine POAG IOP Concentration Frequency Primary open-angle glaucoma Primary open-angle glaucoma suspect

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Pilocarpine Concentration

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

Group Type EXPERIMENTAL

Pilocarpine Concentration

Intervention Type DRUG

Varying concentration 0.5 to 8%

Pilocarpine Frequency

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.

Group Type EXPERIMENTAL

Pilocarpine Frequency

Intervention Type DRUG

1 to 4 times daily

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Pilocarpine Concentration

Varying concentration 0.5 to 8%

Intervention Type DRUG

Pilocarpine Frequency

1 to 4 times daily

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Primary open-angle glaucoma
* Primary open-angle glaucoma suspect
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Wills Eye

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Marlene Moster, MD

Attending Surgeon

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

George L Spaeth, MD

Role: PRINCIPAL_INVESTIGATOR

Wills Eye Glaucoma Service

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Wills Eye Glaucoma Service

Philadelphia, Pennsylvania, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

08-914E

Identifier Type: -

Identifier Source: org_study_id