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

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ClinicalTrials.gov Identifier: NCT02754570
Recruitment Status : Completed
First Posted : April 28, 2016
Last Update Posted : August 28, 2018
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver

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.

Condition or disease Intervention/treatment Phase
Glaucoma, Open-angle Hypertension, Ocular Drug: Pilocarpine Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Diurnal and Nocturnal Effect of Pilocarpine on Intraocular Pressure and Ocular Perfusion Pressure
Study Start Date : July 2016
Actual Primary Completion Date : December 2017
Actual Study Completion Date : February 21, 2018


Arm Intervention/treatment
Experimental: Pilocarpine group
Subjects with open-angle glaucoma and ocular hypertension.
Drug: Pilocarpine
Pilocarpine will be administered 3 times in addition to latanoprost.
Other Name: Pilocarpine Hydrochloride




Primary Outcome Measures :
  1. Change in intraocular pressure [ Time Frame: 1 week - 8 weeks ]
    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 3 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.


Secondary Outcome Measures :
  1. Change in ocular perfusion pressure [ Time Frame: 1 week - 8 weeks ]
    Ocular perfusion pressure will calculated from the intraocular pressure and blood pressure measurements.



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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02754570


Locations
United States, Colorado
University of Colorado Denver Eye Hospital
Denver, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
Investigators
Principal Investigator: Leonard Seibold, MD University of Colorado, Denver

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT02754570     History of Changes
Other Study ID Numbers: 15-1972
UL1TR001082 ( U.S. NIH Grant/Contract )
First Posted: April 28, 2016    Key Record Dates
Last Update Posted: August 28, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by University of Colorado, Denver:
Open-angle glaucoma
Ocular hypertension
Latanoprost
Pilocarpine

Additional relevant MeSH terms:
Hypertension
Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases
Latanoprost
Pilocarpine
Antihypertensive Agents
Miotics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Muscarinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action