The Diurnal and Nocturnal Effect of Pilocarpine on Intraocular Pressure and Ocular Perfusion Pressure

NCT ID: NCT02754570

Last Updated: 2019-11-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-31
• Study Completion Date: 2018-02-21

Brief Summary

The aim of this study will be to determine the effects of pilocarpine as an adjunct medication to latanoprost monotherapy at multiple intervals throughout a 24-hour period and compare these effects to latanoprost alone.

Detailed Description

This study plans to learn more about the effect of pilocarpine on intraocular pressure and ocular perfusion pressure for a full twenty-four hour period.

In this study, the investigators seek to better characterize the knowledge base of the intraocular pressure (IOP) lowering effects of pilocarpine in patients with open angle glaucoma or ocular hypertension who are currently taking latanoprost. The goal is to define the potential additive effect of pilocarpine throughout a 24-hour period, not only for IOP, but for ocular perfusion pressure (defined as 2/3[diastolicBP + 1/3(systolicBP - diastolicBP)] - IOP). These data will allow to expand current knowledge of the effects of pilocarpine and help determine if this medication has a useful role as an adjunctive treatment in glaucoma.

Conditions

Glaucoma, Open-angle; Hypertension, Ocular

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Pilocarpine group

Subjects with open-angle glaucoma and ocular hypertension that are currently taking latanoprost

Group Type: EXPERIMENTAL

Pilocarpine

Intervention Type: DRUG

Pilocarpine will be administered 4 times in addition to latanoprost.

Interventions

Pilocarpine

Pilocarpine will be administered 4 times in addition to latanoprost.

Intervention Type: DRUG

Other Intervention Names

Pilocarpine Hydrochloride

Eligibility Criteria

Inclusion Criteria

• Current confirmed diagnosis of:

• open angle glaucoma, or
• ocular hypertension including pigment dispersion glaucoma, and
• pseudoexfoliation glaucoma.
• Current use of topical latanoprost once a day in both eyes for at least 6 weeks
• any race/ethnicity

Exclusion Criteria

• Females who are currently pregnant or planning to become pregnant during the study period
• Diagnosis of any other form of glaucoma other than open-angle
• Intraocular pressure readings of <14mmHg in either eye when measured during routine office visit in the past 12 months.
• Schaffer angle grade < 2 in either eye by gonioscopy
• Intraocular surgery within 6 months or laser within 3 months
• History of retinal tear or detachment in either eye
• Active iritis in either eye as determined by most recent eye examination
• Patients who smoke or have irregular daily sleep patterns
• Patients who have started or changed glucocorticoids therapy in the last 3 months
• Patients who are currently using medical or recreational marijuana
• Any use of a non-FDA approved medication for glaucoma in the last 3 months

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Leonard Seibold, MD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

University of Colorado Denver Eye Hospital

Denver, Colorado, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

UL1TR001082

Identifier Type: NIH

Identifier Source: secondary_id

View Link

15-1972

Identifier Type: -

Identifier Source: org_study_id