Dose, Effects and Characteristics of Pilocarpine

Phase 4

Completed

• Conditions: Open-angle Glaucoma
• Interventions: Drug: Pilocarpine Concentration; Drug: Pilocarpine Frequency

• Registration Number: NCT00803803
• Lead Sponsor: Wills Eye

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.

Study Timeline

• Study Start: 1978-08
• Primary Completion: 1979-08
• Study Completion: 1979-12
• Study First Submitted: 2008-12-05
• Study First Submitted QC: 2008-12-05
• Study First Posted: 2008-12-08
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-20
• Last Update Posted: 2016-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

Inclusion Criteria

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Pilocarpine Concentration	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
Pilocarpine Frequency	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.

Primary Outcome Measures

Name	Time	Method
Intraocular Pressure	25 days

Trial Locations

Locations (1)

Wills Eye Glaucoma Service; 🇺🇸 Philadelphia, Pennsylvania, United States