Primary Open Angle Glaucoma or Ocular Hypertension
Conditions
Brief summary
To test the safety and effectiveness of AR-13324 0.02% and 0.04% ophthalmic solution relative to placebo in Japanese/Japanese-American subjects with open-angle glaucoma or ocular hypertension in US.
Interventions
Administered to each eye, once daily (QD) in the evening (PM) for 28 days
Administered to each eye, once daily (QD) in the evening (PM) for 28 days
DRUGAR-13324 Ophthalmic Solution Placebo
Administered to each eye, once daily (QD) in the evening (PM) for 28 days
Sponsors
Aerie Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Must be 18 years or older 2. Be of Japanese ethnicity within the 2nd generation defined as (a) 1st generation born in Japan, immigrated to US and (b) 2nd generation - parents are 1st generation and patient was born in US as an American citizen 3. Diagnosis of open-angle glaucoma or ocular hypertension in both eyes 4. Medicated intraocular pressure \>/= 15 mmHg and \< 30 mmHg in both eyes at screening 5. OAG eyes - unmedicated IOP \>/= 15 mmHg and \< 35 mmHg at 2 qualification visits at 08:00, 10:00 and 16:00 6. OHT eyes - unmedicated IOP \>/= 22 mmHg and \< 35mmHg at 08:00, 10:00 and 16:00 7. Best corrected visual acuity + 1.0 logMAR or better by ETDRS in each eye 8. Able to give signed informed consent and follow instructions
Exclusion criteria
1. Clinically significant ocular disease 2. Pseudoexfoliation or pigment dispersion component glaucoma, history of angle closure glaucoma or narrow angles 3. Intraocular pressure \>/=35 mmHg in either eye 4. Ocular hyperemia score of moderate (+2) at qualification visit #2 5. Previous glaucoma intraocular surgery 6. Refractive surgery in either eye 7. Ocular injury within 6 months prior to screening or ocular surgery or non-refractive laser treatment within 3 months prior to screening 8. Recent or current ocular infection or inflammation in either eye 9. Use of ocular medication in either eye of any kind within 30 days of screening and throughout the study 10. Mean central corneal thickness \> 620 µm in either eye 11. Any abnormality preventing reliable applanation tonometry of either eye 12. Known hypersensitivity to benzalkonium chloride or excipients of netarsudil ophthalmic solution 13. Clinically significant abnormalities in screening lab tests 14. Clinically significant systemic disease that might interfere with the study 15. Participated in any investigational study within 30 days prior to screening 16. Systemic medication that could have a substantial effect on IOP within 30 days prior to screening or anticipated during the study 17. Women of child-bearing 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 |
|---|---|---|
| Mean Diurnal IOP (Intraocular Pressure) (mmHg) | 28 Days | Mean diurnal intraocular pressure (IOP) at week 4, measured by Goldman Applanation Tonometry (GAT). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Extent of Exposure | 28 Days | Exposure to study medication in days for all treatment groups |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| AR-13324 Ophthalmic Solution 0.02% AR-13324 Ophthalmic Solution 0.02%: Topical sterile ophthalmic solution; 1 drop daily to each eye for 28 days | 14 |
| AR-13324 Ophthalmic Solution 0.04% AR-13324 Ophthalmic Solution 0.04%: Topical sterile ophthalmic solution; 1 drop daily to each eye for 28 days | 14 |
| Placebo Comparator AR-13324 Ophthalmic Solution Placebo: Topical sterile ophthalmic solution; 1 drop daily to each eye for 28 days | 12 |
| Total | 40 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | AR-13324 Ophthalmic Solution 0.02% | AR-13324 Ophthalmic Solution 0.04% | Placebo Comparator | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 6 Participants | 6 Participants | 6 Participants | 18 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants | 8 Participants | 6 Participants | 22 Participants |
| Age, Continuous | 61.1 years STANDARD_DEVIATION 20.32 | 60.9 years STANDARD_DEVIATION 12.12 | 65.6 years STANDARD_DEVIATION 14.98 | 62.4 years STANDARD_DEVIATION 15.95 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 14 Participants | 14 Participants | 12 Participants | 40 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Japanese 1st Generation | 11 Participants | 12 Participants | 6 Participants | 29 Participants |
| Race/Ethnicity, Customized Japanese 2nd Generation | 3 Participants | 2 Participants | 6 Participants | 11 Participants |
| Region of Enrollment United States | 14 participants | 14 participants | 12 participants | 40 participants |
| Sex: Female, Male Female | 10 Participants | 11 Participants | 8 Participants | 29 Participants |
| Sex: Female, Male Male | 4 Participants | 3 Participants | 4 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 14 | 0 / 12 |
| other Total, other adverse events | 10 / 15 | 11 / 14 | 3 / 12 |
| serious Total, serious adverse events | 0 / 15 | 0 / 14 | 0 / 12 |
Outcome results
Primary
Mean Diurnal IOP (Intraocular Pressure) (mmHg)
Mean diurnal intraocular pressure (IOP) at week 4, measured by Goldman Applanation Tonometry (GAT).
Time frame: 28 Days
Population: Intent to treat (ITT) population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AR-13324 Ophthalmic Solution 0.02% | Mean Diurnal IOP (Intraocular Pressure) (mmHg) | 14.35 mmHg | Standard Error 0.549 |
| AR-13324 Ophthalmic Solution 0.04% | Mean Diurnal IOP (Intraocular Pressure) (mmHg) | 14.33 mmHg | Standard Error 0.567 |
| Placebo Comparator | Mean Diurnal IOP (Intraocular Pressure) (mmHg) | 17.32 mmHg | Standard Error 0.576 |
Secondary
Extent of Exposure
Exposure to study medication in days for all treatment groups
Time frame: 28 Days
Population: Exposure to study medication in days for all treatment groups
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AR-13324 Ophthalmic Solution 0.02% | Extent of Exposure | 27.9 Days | Standard Deviation 1.91 |
| AR-13324 Ophthalmic Solution 0.04% | Extent of Exposure | 26.8 Days | Standard Deviation 7.56 |
| Placebo Comparator | Extent of Exposure | 27.4 Days | Standard Deviation 2.23 |