NCT02754570

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 20, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 28, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2016

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 21, 2018

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

November 7, 2019

Completed
Last Updated

November 7, 2019

Status Verified

October 1, 2019

Enrollment Period

1.4 years

First QC Date

April 20, 2016

Results QC Date

June 26, 2019

Last Update Submit

October 16, 2019

Conditions

Glaucoma, Open-angleHypertension, Ocular

Keywords

Open-angle glaucomaOcular hypertensionLatanoprostPilocarpine

Outcome Measures

Primary Outcomes (1)

  • Change in Intraocular Pressure From Baseline at Visit 3

    Subjects will be enrolled at the first visit. Patients already on latanoprost may proceed immediately with the second visit. Patients on a different prostaglandin analog medication will be switched to latanoprost for at least 6 weeks. At second visit, intraocular pressure and blood pressure will be measured every 2 hours for a 24-hour period. At any point over the next 4 weeks, another 24-hour visit will be performed. This time, a dose of pilocarpine 2% will be administered at 4 different times in addition to the latanoprost . As before, intraocular pressure and blood pressure will be measured every 2 hours. After visit 3, subjects will return to their prior treatment regimen. Change in the intraocular pressure from the second and the third visit will be determined. 8 diurnal readings and 4 nocturnal readings were averaged separately during both Visit 2 for the PGA Monotherapy and Visit 3 for Pilocarpine+PGA

    Two 24-hour visits: Baseline/Visit 2; Up to week 4/Visit 3

Secondary Outcomes (1)

  • Change in Ocular Perfusion Pressure

    Two 24-hour visits: Baseline/Visit 2; Up to week 4/Visit 3

Study Arms (1)

Pilocarpine group

EXPERIMENTAL

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

Drug: Pilocarpine

Interventions

PilocarpineDRUG

Pilocarpine will be administered 4 times in addition to latanoprost.

Also known as: Pilocarpine Hydrochloride
Pilocarpine group

Eligibility Criteria

Age18 Years - 89 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Colorado Denver Eye Hospital

Denver, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Glaucoma, Open-AngleOcular Hypertension

Interventions

Pilocarpine

Condition Hierarchy (Ancestors)

GlaucomaEye Diseases

Intervention Hierarchy (Ancestors)

AlkaloidsHeterocyclic Compounds

Results Point of Contact

Title
Rachel Gerle
Organization
University of Colorado
rachel.gerle@ucdenver.edu
720-848-5096

Study Officials

  • Leonard Seibold, MD

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 20, 2016

First Posted

April 28, 2016

Study Start

July 1, 2016

Primary Completion

December 1, 2017

Study Completion

February 21, 2018

Last Updated

November 7, 2019

Results First Posted

November 7, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)