Clinical trial NCT02754570: The Diurnal and Nocturnal Effect of Pilocarpine on Intraocular Pressure and Ocular Perfusion Pressure
Official title: The Diurnal and Nocturnal Effect of Pilocarpine on Intraocular Pressure and Ocular Perfusion Pressure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glaucoma, Open-angle
Hypertension, Ocular
Keywords: Open-angle glaucoma
Ocular hypertension
Latanoprost
Pilocarpine
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2016-04-28
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in Intraocular Pressure From Baseline at Visit 3
timeFrame: Two 24-hour visits: Baseline/Visit 2; Up to week 4/Visit 3
Secondary outcomes:
measure: Change in Ocular Perfusion Pressure
timeFrame: Two 24-hour visits: Baseline/Visit 2; Up to week 4/Visit 3
Other outcomes:
Locations:
city: Denver
country: United States
facility: University of Colorado Denver Eye Hospital
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Leonard Seibold, MD
role: PRINCIPAL_INVESTIGATOR
References: