Dose, Effects and Characteristics of Pilocarpine

Wills Eye

Status and phase: Completed; Phase 4

Conditions: Open-angle Glaucoma

Treatments: Drug: Pilocarpine Concentration; Drug: Pilocarpine Frequency

Study type: Interventional

Funder types: Other

Identifiers

NCT00803803

08-914E

Details and patient eligibility

About

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.

Full description

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

Enrollment: 37 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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37 participants in 2 patient groups

Pilocarpine Concentration

Experimental group

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

Treatment:

Drug: Pilocarpine Concentration

Pilocarpine Frequency

Experimental group

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.

Treatment:

Drug: Pilocarpine Frequency