Open Angle Glaucoma, Ocular Hypertension
Conditions
Keywords
Open Angle Glaucoma, Ocular Hypertension, Intraocular Pressure, AR13324, PG324
Brief summary
To evaluate the ocular hypotensive efficacy of PG324 ophthalmic solution relative to its individual components in patients with open angle glaucoma or ocular hypertension.
Interventions
DRUGPG324 Ophthalmic Solution 0.01%
1 drop in the evening (PM), once daily (QD), both eyes (OU)
DRUGPG324 Ophthalmic Solution 0.02%
1 drop in the evening (PM), once daily (QD), both eyes (OU)
1 drop in the evening (PM), once daily (QD), both eyes (OU)
1 drop in the evening (PM), once daily (QD), both eyes (OU)
Sponsors
Aerie Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years of age or greater. * Diagnosis of open angle glaucoma (OAG) or ocular hypertension (OHT) * Corrected visual acuity in each eye equivalent to 20/200 or better * Able and willing to give signed informed consent and follow study instructions.
Exclusion criteria
Ophthalmic: * Glaucoma: pseudoexfoliation or pigment dispersion component, history of angle closure, or narrow angles. * Intraocular pressure \>36 mmHg * Known hypersensitivity to any component of the formulation, latanoprost, or to topical anesthetics. * Previous glaucoma intraocular surgery or glaucoma laser procedures in study eye(s) * Refractive surgery in study eye(s) * Ocular trauma within the six months prior to screening, or ocular surgery or laser treatment within the three months prior to screening. * Evidence of ocular infection and inflammation * Clinically significant ocular disease, which might interfere with the study, including glaucomatous damage so severe that washout of ocular hypotensive medications for one month is not judged safe * Central corneal thickness greater then 600 μm * Any abnormality preventing reliable applanation tonometry of either eye Systemic: * Clinically significant abnormalities (as determined by the investigator) in laboratory tests at screening. * Clinically significant systemic disease * Participation in any investigational study within 30 days prior to screening * Changes in systemic medication * Women of childbearing potential who are pregnant, nursing, planning a pregnancy, or not using a medically acceptable form of birth control.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intraocular Pressure (IOP) | Study treatment was administered for 28 days, and outcome measures collected on Day 29 | The primary efficacy endpoint was the mean diurnal IOP across subjects within treatment group at Day 29. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| PG324 Ophthalmic Solution 0.01% PG324 Ophthalmic Solution 0.01%
1 drop in the evening (PM), once daily (QD), both eyes (OU) | 74 |
| PG324 Ophthalmic Solution 0.02% PG324 Ophthalmic Solution 0.02%
1 drop in the evening (PM), once daily (QD), both eyes (OU) | 73 |
| Netarsudil (AR-13324) Ophthalmic Solution 0.02% Netarsudil (AR-13324) Ophthalmic Solution 0.02%
1 drop in the evening (PM), once daily (QD), both eyes (OU) | 78 |
| Latanoprost Ophthalmic Solution 0.005% Latanoprost Ophthalmic Solution 0.005%
1 drop daily in the evening (PM), once daily (QD), both eyes (OU) | 73 |
| Total | 298 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 2 | 0 | 1 |
| Overall Study | Dissallowed Concurrent Medication | 0 | 1 | 0 | 0 |
| Overall Study | Protocol Violation | 0 | 1 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Total | PG324 Ophthalmic Solution 0.01% | PG324 Ophthalmic Solution 0.02% | Netarsudil (AR-13324) Ophthalmic Solution 0.02% | Latanoprost Ophthalmic Solution 0.005% |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 173 Participants | 45 Participants | 38 Participants | 45 Participants | 45 Participants |
| Age, Categorical Between 18 and 65 years | 125 Participants | 29 Participants | 35 Participants | 33 Participants | 28 Participants |
| Age, Continuous | 64.9 years STANDARD_DEVIATION 11.57 | 65.4 years STANDARD_DEVIATION 11.26 | 64.2 years STANDARD_DEVIATION 11.07 | 64.8 years STANDARD_DEVIATION 11.28 | 65.1 years STANDARD_DEVIATION 12.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 64 Participants | 15 Participants | 20 Participants | 15 Participants | 14 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 234 Participants | 59 Participants | 53 Participants | 63 Participants | 59 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 7 Participants | 3 Participants | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 54 Participants | 15 Participants | 10 Participants | 17 Participants | 12 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 236 Participants | 56 Participants | 62 Participants | 58 Participants | 60 Participants |
| Sex: Female, Male Female | 175 Participants | 47 Participants | 39 Participants | 43 Participants | 46 Participants |
| Sex: Female, Male Male | 123 Participants | 27 Participants | 34 Participants | 35 Participants | 27 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 74 | 0 / 73 | 0 / 78 | 0 / 73 |
| other Total, other adverse events | 46 / 73 | 55 / 73 | 49 / 78 | 12 / 73 |
| serious Total, serious adverse events | 0 / 74 | 0 / 73 | 0 / 78 | 3 / 73 |
Outcome results
Primary
Intraocular Pressure (IOP)
The primary efficacy endpoint was the mean diurnal IOP across subjects within treatment group at Day 29.
Time frame: Study treatment was administered for 28 days, and outcome measures collected on Day 29
Population: Modified intent to treat (mITT) population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PG324 Ophthalmic Solution 0.01% | Intraocular Pressure (IOP) | Day 1, Diurnal Mean | 25.11 mmHg | Standard Deviation 2.33 |
| PG324 Ophthalmic Solution 0.01% | Intraocular Pressure (IOP) | Day 29, Diurnal Mean | 17.33 mmHg | Standard Deviation 2.77 |
| PG324 Ophthalmic Solution 0.02% | Intraocular Pressure (IOP) | Day 29, Diurnal Mean | 16.52 mmHg | Standard Deviation 2.992 |
| PG324 Ophthalmic Solution 0.02% | Intraocular Pressure (IOP) | Day 1, Diurnal Mean | 25.12 mmHg | Standard Deviation 2.374 |
| Netarsudil (AR-13324) Ophthalmic Solution | Intraocular Pressure (IOP) | Day 1, Diurnal Mean | 25.35 mmHg | Standard Deviation 2.666 |
| Netarsudil (AR-13324) Ophthalmic Solution | Intraocular Pressure (IOP) | Day 29, Diurnal Mean | 19.13 mmHg | Standard Deviation 3.219 |
| Latanoprost Ophthalmic Solution | Intraocular Pressure (IOP) | Day 1, Diurnal Mean | 25.99 mmHg | Standard Deviation 2.828 |
| Latanoprost Ophthalmic Solution | Intraocular Pressure (IOP) | Day 29, Diurnal Mean | 18.44 mmHg | Standard Deviation 2.565 |
p-value: <0.0001t-test, 2 sided
p-value: <0.0001t-test, 2 sided
p-value: <0.0001t-test, 2 sided
p-value: <0.0001t-test, 2 sided