Dose, Effects and Characteristics of Pilocarpine

This study has been completed.

Sponsor:

Information provided by:

Wills Eye

ClinicalTrials.gov Identifier:

NCT00803803

First received: December 5, 2008

Last updated: December 8, 2008

Last verified: December 2008

History of Changes

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.

Condition	Intervention	Phase
Open-Angle Glaucoma	Drug: Pilocarpine Concentration Drug: Pilocarpine Frequency	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Dose, Effects and Characteristics of Pilocarpine

Resource links provided by NLM:

Genetics Home Reference related topics: early-onset glaucoma

MedlinePlus related topics: Glaucoma

Drug Information available for: Pilocarpine hydrochloride Pilocarpine

U.S. FDA Resources

Further study details as provided by Wills Eye:

Primary Outcome Measures:

Intraocular Pressure [ Time Frame: 25 days ] [ Designated as safety issue: Yes ]

Enrollment:	37
Study Start Date:	August 1978
Study Completion Date:	December 1979
Primary Completion Date:	August 1979 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 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	Drug: Pilocarpine Concentration Varying concentration 0.5 to 8%
Experimental: 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.	Drug: Pilocarpine Frequency 1 to 4 times daily

Arms

Assigned Interventions

Experimental: 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

Drug: Pilocarpine Concentration

Varying concentration 0.5 to 8%

Experimental: 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.

Drug: Pilocarpine Frequency

1 to 4 times daily

Eligibility

Ages Eligible for Study:	18 Years to 90 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Primary open-angle glaucoma
Primary open-angle glaucoma suspect

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00803803

Locations

United States, Pennsylvania
Wills Eye Glaucoma Service
Philadelphia, Pennsylvania, United States, 19107

Sponsors and Collaborators

Wills Eye

Investigators

Principal Investigator:

George L Spaeth, MD

Wills Eye Glaucoma Service

More Information

No publications provided

Responsible Party:	George L. Spaeth, M.D., Wills Glaucoma Service
ClinicalTrials.gov Identifier:	NCT00803803 History of Changes
Other Study ID Numbers:	08-914E
Study First Received:	December 5, 2008
Last Updated:	December 8, 2008
Health Authority:	United States: Institutional Review Board

Keywords provided by Wills Eye:

Pilocarpine
POAG
IOP
Concentration

Frequency
Primary open-angle glaucoma
Primary open-angle glaucoma suspect

Additional relevant MeSH terms:

Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Eye Diseases
Pilocarpine
Miotics
Autonomic Agents
Peripheral Nervous System Agents

Physiological Effects of Drugs
Pharmacologic Actions
Muscarinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 17, 2013

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