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

University of Colorado Denver (CU Denver) logo

University of Colorado Denver (CU Denver)

Status

Completed

Conditions

Hypertension, Ocular
Glaucoma, Open-angle

Treatments

Drug: Pilocarpine

Study type

Interventional

Funder types

Other

Identifiers

NCT02754570
15-1972
UL1TR001082 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment

27 patients

Sex

All

Ages

18 to 89 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

27 participants in 1 patient group

Pilocarpine group
Experimental group
Description:
Subjects with open-angle glaucoma and ocular hypertension that are currently taking latanoprost
Treatment:
Drug: Pilocarpine

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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