Trial Outcomes & Findings for The Diurnal and Nocturnal Effect of Pilocarpine on Intraocular Pressure and Ocular Perfusion Pressure (NCT NCT02754570)
NCT ID: NCT02754570
Last Updated: 2019-11-07
Results Overview
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
COMPLETED
NA
27 participants
Two 24-hour visits: Baseline/Visit 2; Up to week 4/Visit 3
2019-11-07
Participant Flow
Participant milestones
| Measure |
Pilocarpine Group
Subjects with open-angle glaucoma and ocular hypertension.
Pilocarpine: Pilocarpine will be administered 4 times in addition to latanoprost.
|
|---|---|
|
Overall Study
STARTED
|
27
|
|
Overall Study
Visits 1 and 2 (PGA Only)
|
27
|
|
Overall Study
Visit 3 (PGA + Pilocarpine)
|
27
|
|
Overall Study
COMPLETED
|
27
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Diurnal and Nocturnal Effect of Pilocarpine on Intraocular Pressure and Ocular Perfusion Pressure
Baseline characteristics by cohort
| Measure |
Pilocarpine Group
n=27 Participants
Subjects with open-angle glaucoma and ocular hypertension.
Pilocarpine: Pilocarpine will be administered 4 times in addition to latanoprost.
|
|---|---|
|
Age, Continuous
|
68.3 years
STANDARD_DEVIATION 10.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
25 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
27 participants
n=5 Participants
|
|
Diagnosis
Primary Open Angle Glaucoma
|
21 Participants
n=5 Participants
|
|
Diagnosis
Ocular Hypertension
|
4 Participants
n=5 Participants
|
|
Diagnosis
Pseudoexfoliation Glaucoma
|
2 Participants
n=5 Participants
|
|
Lens Status
Phakic
|
19 Participants
n=5 Participants
|
|
Lens Status
Pseudophakic
|
8 Participants
n=5 Participants
|
|
Prior Laser Surgery
Laser Peripheral Iridotomy
|
5 Participants
n=5 Participants
|
|
Prior Laser Surgery
Selective Laser Trabeculoplasty
|
3 Participants
n=5 Participants
|
|
Prior Laser Surgery
No Prior Laser
|
19 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Two 24-hour visits: Baseline/Visit 2; Up to week 4/Visit 3Population: Patients who are using a prostaglandin analog (PGA) will be monitored at visit two. At visit 3, pilocarpine will be added four times per day to the PGA therapy.
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
Outcome measures
| Measure |
Pilocarpine Group
n=27 Participants
Subjects with open-angle glaucoma, ocular hypertension or pseudoexfoliation glaucoma.
Pilocarpine: Pilocarpine will be administered 4 times in addition to latanoprost or brimonidine
|
|---|---|
|
Change in Intraocular Pressure From Baseline at Visit 3
Visit 2: Nocturnal PGA
|
21.1 mmHg
Standard Error 0.7
|
|
Change in Intraocular Pressure From Baseline at Visit 3
Visit 2: Diurnal PGA
|
18.2 mmHg
Standard Error 0.5
|
|
Change in Intraocular Pressure From Baseline at Visit 3
Visit 3: Nocturnal PGA
|
20.0 mmHg
Standard Error 0.6
|
|
Change in Intraocular Pressure From Baseline at Visit 3
Visit 3: Diurnal PGA
|
17.1 mmHg
Standard Error 0.4
|
SECONDARY outcome
Timeframe: Two 24-hour visits: Baseline/Visit 2; Up to week 4/Visit 3Population: Patients who are using a prostaglandin analog (PGA) will be monitored at visit two. At visit 3, pilocarpine will be added four times per day to the PGA therapy.
Ocular perfusion pressure will calculated from the intraocular pressure and blood pressure measurements. At Baseline/Visit 2, 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 (Visit 3) will be performed. This time, a dose of pilocarpine 2% will be administered at 4 different times in addition to the latanoprost (PGA monotherapy). As before, intraocular pressure and blood pressure will be measured every 2 hours. 8 diurnal readings and 4 nocturnal readings were averaged separately during both Visit 2 for the PGA Monotherapy and Visit 3 for Pilocarpine+PGA
Outcome measures
| Measure |
Pilocarpine Group
n=27 Participants
Subjects with open-angle glaucoma, ocular hypertension or pseudoexfoliation glaucoma.
Pilocarpine: Pilocarpine will be administered 4 times in addition to latanoprost or brimonidine
|
|---|---|
|
Change in Ocular Perfusion Pressure
Visit 2: Diurnal Ocular Perfusion Pressure
|
44.12 mmHg
Standard Deviation 1.2
|
|
Change in Ocular Perfusion Pressure
Visit 2: Nocturnal Ocular Perfusion Pressure
|
37.2 mmHg
Standard Deviation 1.3
|
|
Change in Ocular Perfusion Pressure
Visit 2: Diurnal Systolic Blood Pressure
|
132.5 mmHg
Standard Deviation 2.8
|
|
Change in Ocular Perfusion Pressure
Visit 2: Nocturnal Systolic Blood Pressure
|
125.8 mmHg
Standard Deviation 2.9
|
|
Change in Ocular Perfusion Pressure
Visit 3: Diurnal Ocular Perfusion Pressure
|
44.3 mmHg
Standard Deviation 1.1
|
|
Change in Ocular Perfusion Pressure
Visit 3: Nocturnal Ocular Profusion Pressure
|
37.1 mmHg
Standard Deviation 1.2
|
|
Change in Ocular Perfusion Pressure
Visit 3: Diurnal Systolic Blood Pressure
|
130.8 mmHg
Standard Deviation 2.9
|
|
Change in Ocular Perfusion Pressure
Visit 3: Nocturnal Systolic Blood Pressure
|
122.7 mmHg
Standard Deviation 2.9
|
Adverse Events
Pilocarpine Group
PGA Monotherapy
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place