Glaucoma, Open-angle, Hypertension, Ocular
Conditions
Keywords
Open-angle glaucoma, Ocular hypertension, Latanoprost, Pilocarpine
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.
Interventions
DRUGPilocarpine
Pilocarpine will be administered 4 times in addition to latanoprost.
Sponsors
University of Colorado, Denver
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Intraocular Pressure From Baseline at Visit 3 | Two 24-hour visits: Baseline/Visit 2; Up to week 4/Visit 3 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Ocular Perfusion Pressure | Two 24-hour visits: Baseline/Visit 2; Up to week 4/Visit 3 | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Pilocarpine Group Subjects with open-angle glaucoma and ocular hypertension.
Pilocarpine: Pilocarpine will be administered 4 times in addition to latanoprost. | 27 |
| Total | 27 |
Baseline characteristics
| Characteristic | Pilocarpine Group |
|---|---|
| Age, Continuous | 68.3 years STANDARD_DEVIATION 10.8 |
| Diagnosis Ocular Hypertension | 4 Participants |
| Diagnosis Primary Open Angle Glaucoma | 21 Participants |
| Diagnosis Pseudoexfoliation Glaucoma | 2 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 25 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Lens Status Phakic | 19 Participants |
| Lens Status Pseudophakic | 8 Participants |
| Prior Laser Surgery Laser Peripheral Iridotomy | 5 Participants |
| Prior Laser Surgery No Prior Laser | 19 Participants |
| Prior Laser Surgery Selective Laser Trabeculoplasty | 3 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 19 Participants |
| Region of Enrollment United States | 27 participants |
| Sex: Female, Male Female | 20 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 27 | 0 / 27 |
| other Total, other adverse events | 0 / 27 | 0 / 27 |
| serious Total, serious adverse events | 0 / 27 | 0 / 27 |
Outcome results
Primary
Change in Intraocular Pressure From Baseline at Visit 3
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
Time frame: Two 24-hour visits: Baseline/Visit 2; Up to week 4/Visit 3
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pilocarpine Group | Change in Intraocular Pressure From Baseline at Visit 3 | Visit 2: Nocturnal PGA | 21.1 mmHg | Standard Error 0.7 |
| Pilocarpine Group | Change in Intraocular Pressure From Baseline at Visit 3 | Visit 2: Diurnal PGA | 18.2 mmHg | Standard Error 0.5 |
| Pilocarpine Group | Change in Intraocular Pressure From Baseline at Visit 3 | Visit 3: Nocturnal PGA | 20.0 mmHg | Standard Error 0.6 |
| Pilocarpine Group | Change in Intraocular Pressure From Baseline at Visit 3 | Visit 3: Diurnal PGA | 17.1 mmHg | Standard Error 0.4 |
Secondary
Change in Ocular Perfusion Pressure
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
Time frame: Two 24-hour visits: Baseline/Visit 2; Up to week 4/Visit 3
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pilocarpine Group | Change in Ocular Perfusion Pressure | Visit 2: Diurnal Ocular Perfusion Pressure | 44.12 mmHg | Standard Deviation 1.2 |
| Pilocarpine Group | Change in Ocular Perfusion Pressure | Visit 2: Nocturnal Ocular Perfusion Pressure | 37.2 mmHg | Standard Deviation 1.3 |
| Pilocarpine Group | Change in Ocular Perfusion Pressure | Visit 2: Diurnal Systolic Blood Pressure | 132.5 mmHg | Standard Deviation 2.8 |
| Pilocarpine Group | Change in Ocular Perfusion Pressure | Visit 2: Nocturnal Systolic Blood Pressure | 125.8 mmHg | Standard Deviation 2.9 |
| Pilocarpine Group | Change in Ocular Perfusion Pressure | Visit 3: Diurnal Ocular Perfusion Pressure | 44.3 mmHg | Standard Deviation 1.1 |
| Pilocarpine Group | Change in Ocular Perfusion Pressure | Visit 3: Nocturnal Ocular Profusion Pressure | 37.1 mmHg | Standard Deviation 1.2 |
| Pilocarpine Group | Change in Ocular Perfusion Pressure | Visit 3: Diurnal Systolic Blood Pressure | 130.8 mmHg | Standard Deviation 2.9 |
| Pilocarpine Group | Change in Ocular Perfusion Pressure | Visit 3: Nocturnal Systolic Blood Pressure | 122.7 mmHg | Standard Deviation 2.9 |