Study of Netarsudil Ophthalmic Solution in Subjects With Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT)
Status: | Completed |
---|---|
Conditions: | High Blood Pressure (Hypertension), Ocular |
Therapuetic Areas: | Cardiology / Vascular Diseases, Ophthalmology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 6/20/2018 |
Start Date: | October 20, 2017 |
End Date: | April 19, 2018 |
A Double-Masked, Randomized, Placebo-Controlled Study of Trabecular Outflow Facility Following Treatment With Netarsudil Ophthalmic Solution 0.02% (AR-13324) in Subjects With Elevated Intraocular Pressure
To evaluate the effect on trabecular outflow facility of Netarsudil ophthalmic solution 0.02%
compared to placebo
compared to placebo
Inclusion Criteria:
1. Must be 18 years of age or older
2. Diagnosis of open angle glaucoma or ocular hypertension in both eyes
3. Unmedicated intraocular pressure >20 mmHg and < 30 mmHg in both eyes at first
qualification visit
4. Corrected visual acuity equivalent to 20/200
5. Able to give informed consent and follow study instructions
Exclusion Criteria:
Ophthalmic
1. Clinically significant ocular disease
2. Pseudoexfoliation or pigment dispersion component glaucoma, history of angle closure
glaucoma, or narrow angles
3. Intraocular pressure ≥30 mmHg in either eye
4. A difference in IOP between eyes >4mmHg at qualification visit
5. Use of more than two ocular hypotensive medications within 30 days of screening
6. Known hypersensitivity to any component of the formulation
7. Previous glaucoma surgery or refractive surgery
8. Report of ocular injury in either eye within the six months prior to screening or
ocular or non-refractive surgery within 3 months prior to screening
9. Recent or current ocular infection or inflammation in either eye
10. Use of ocular medication in either eye of any kind within 30 days of screening
11. Mean central corneal thickness greater than 620 μm in either eye
12. Any abnormality preventing reliable applanation tonometry of either eye
Systemic:
13. Clinically significant abnormalities in any recent laboratory tests within 6 weeks
prior to screening
14. Clinically significant systemic disease
15. Participation in any investigational study within 60 days prior to screening
16. Use of systemic medication that could have an effect on intraocular pressure within 30
days prior to screening
17. Women who are pregnant, nursing, planning a pregnancy, or not using a medically
acceptable form of birth control
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