N/A
N=27
The Diurnal and Nocturnal Effect of Pilocarpine on Intraocular Pressure and Ocular Perfusion Pressure
Glaucoma, Open-angle · Hypertension, Ocular
Bottom Line
View on ClinicalTrials.gov: NCT02754570 ↗Enrolled (actual)
27
Serious AEs
0.0%
Results posted
Nov 2019
Primary outcome: Primary: Change in Intraocular Pressure From Baseline at Visit 3 — 21.1; 18.2; 20.0; 17.1 mmHg
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Pilocarpine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Colorado, Denver
- Primary completion
- Dec 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Intraocular Pressure From Baseline at Visit 3 |
21.1; 18.2; 20.0; 17.1 | — |
| SECONDARY Change in Ocular Perfusion Pressure |
44.12; 37.2; 132.5; 125.8; 44.3; 37.1 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT02754570). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.