Ocular Hypertension, Open Angle Glaucoma
Conditions
Brief summary
To evaluate effect of Netarsudil Ophthalmic Solution 0.02% on Nocturnal and Diurnal Intraocular Pressure.
Interventions
Once daily in both eyes (OU) in the evening (PM) for 7 days
OTHERNetarsudil Ophthalmic Solution Vehicle
Once daily in both eyes (OU) in the evening (PM) for 7 days
Sponsors
Aerie Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 18 years of age or older. 2. Ocular hypertension or open-angle glaucoma in both eyes. 3. Unmedicated intraocular pressure \> 17 mmHg in one or both eyes and \< 30 mmHg in both eyes. 4. Corrected visual acuity in each eye equivalent to 20/200 or better. 5. Able and willing to give signed informed consent and follow study instructions.
Exclusion criteria
1. Glaucoma with pseudoexfoliation or pigment dispersion component, history of angle closure, narrow angles. 2. Intraocular pressure ≥ 30 mmHg. 3. Use of ocular medications within 30 days. 4. Known hypersensitivity to any component of the test formulations or to medications used routinely during a clinical eye examination. 5. Previous eye surgery (other than cataract). 6. Ocular trauma within 6 months. 7. Clinically significant ocular disease that might interfere with the study. 8. Central corneal thickness greater than 620 µm.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Intraocular Pressure (IOP) Over Nocturnal Time Period | Assessed over 24 hours at 9 pm, midnight, 3 am and 6 am on days 1/2 and 8/9 | The primary efficacy endpoint was the mean change from baseline in mean nocturnal IOP (defined as the mean of the 4 nocturnal time points: 21:00, 00:00, 03:00, and 06:00 hours) on Day 8/Day 9 |
Secondary
| Measure | Time frame |
|---|---|
| Number of Participants With Adverse Events as a Measure of Safety and Tolerability | 7 days (day 1/2 to day 8/9) |
Countries
United States
Participant flow
Pre-assignment details
Subjects who agreed to participate in this study were assessed during a screening visit and those who were already using ocular hypotensive medication had to undergo a washout for a specified period (5 days to 4 weeks, depending on the medication) prior to the Qualification visit.
Participants by arm
| Arm | Count |
|---|---|
| Netarsudil Ophthalmic Solution 0.02% 1 drop in each eye daily (OU) in the evening (PM) | 8 |
| Netarsudil Ophthalmic Solution Vehicle 1 drop in each eye daily (OU) in the evening | 4 |
| Total | 12 |
Baseline characteristics
| Characteristic | Netarsudil Ophthalmic Solution Vehicle | Total | Netarsudil Ophthalmic Solution 0.02% |
|---|---|---|---|
| Age, Continuous | 64.5 years STANDARD_DEVIATION 5.07 | 64.4 years STANDARD_DEVIATION 8.58 | 64.4 years STANDARD_DEVIATION 10.23 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 2 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 3 Participants | 10 Participants | 7 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 9 Participants | 6 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 1 Participants | 3 Participants | 2 Participants |
| Sex: Female, Male Female | 2 Participants | 6 Participants | 4 Participants |
| Sex: Female, Male Male | 2 Participants | 6 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 8 | 0 / 4 |
| other Total, other adverse events | 0 / 8 | 0 / 4 |
| serious Total, serious adverse events | 0 / 8 | 0 / 4 |
Outcome results
Primary
Change in Intraocular Pressure (IOP) Over Nocturnal Time Period
The primary efficacy endpoint was the mean change from baseline in mean nocturnal IOP (defined as the mean of the 4 nocturnal time points: 21:00, 00:00, 03:00, and 06:00 hours) on Day 8/Day 9
Time frame: Assessed over 24 hours at 9 pm, midnight, 3 am and 6 am on days 1/2 and 8/9
Population: ITT
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Netarsudil Ophthalmic Solution 0.02% | Change in Intraocular Pressure (IOP) Over Nocturnal Time Period | Baseline (Day 1/2); nocturnal mean | 22.84 mmHg | Standard Deviation 2.21 |
| Netarsudil Ophthalmic Solution 0.02% | Change in Intraocular Pressure (IOP) Over Nocturnal Time Period | Visit 4 (Day 8/9); nocturnal mean | 19.38 mmHg | Standard Deviation 2.86 |
| Netarsudil Ophthalmic Solution Vehicle | Change in Intraocular Pressure (IOP) Over Nocturnal Time Period | Baseline (Day 1/2); nocturnal mean | 23.56 mmHg | Standard Deviation 1.94 |
| Netarsudil Ophthalmic Solution Vehicle | Change in Intraocular Pressure (IOP) Over Nocturnal Time Period | Visit 4 (Day 8/9); nocturnal mean | 23.19 mmHg | Standard Deviation 1.95 |
Secondary
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Time frame: 7 days (day 1/2 to day 8/9)
Population: ITT
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Netarsudil Ophthalmic Solution 0.02% | Number of Participants With Adverse Events as a Measure of Safety and Tolerability | 0 Participants |
| Netarsudil Ophthalmic Solution Vehicle | Number of Participants With Adverse Events as a Measure of Safety and Tolerability | 0 Participants |