Phase 2
Completed N=20
Study of Netarsudil Ophthalmic Solution in Subjects With Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT)
Primary Open Angle Glaucoma or Ocular Hypertension
Source: ClinicalTrials.gov NCT03233308 ↗
Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Jun 2019
Primary outcomePrimary: Mean Change From Baseline in the Mean Diurnal Trabecular Outflow Facility — 0.039; 0.007 mcl/min/mmHg — p=0.0010
Summary
To evaluate the effect on trabecular outflow facility of Netarsudil ophthalmic solution 0.02% compared to placebo
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change From Baseline in the Mean Diurnal Trabecular Outflow Facility |
0.039; 0.007 | 0.0010 sig |
| PRIMARY Mean Percent Change From Baseline in the Mean Diurnal Trabecular Outflow Facility. |
34.589; 9.597 | 0.0003 sig |
| SECONDARY Mean Change From Baseline in Episcleral Venous Pressure (EVP) and in Intraocular Pressure (IOP) |
-0.787; 0.103; -4.521; -0.979 | 0.0687 |
| SECONDARY Mean Percent Change From Baseline in Episcleral Venous Pressure (EVP) and in Intraocular Pressure (IOP) |
-9.465; 3.103; -19.568; -4.227 | 0.0087 sig |
Eligibility Criteria
Inclusion Criteria
- Must be 18 years of age or older
- Diagnosis of open primary angle glaucoma(POAG) or ocular hypertension (OHT) in both eyes
- Unmedicated intraocular pressure (IOP) >20 mmHg and 4mmHg at qualification visit
- Use of more than two ocular hypotensive medications within 30 days of screening
- Known hypersensitivity to any component of the formulation
- Previous glaucoma surgery or refractive surgery
- Keratorefractive surgery in either eye
- 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
- Recent or current ocular infection or inflammation in either eye
- Use of ocular medication in either eye of any kind within 30 days of screening
- Mean central corneal thickness greater than 620 μm in either eye
- Any abnormality preventing reliable applanation tonometry of either eye
- Lack of suitable episcleral vein prior to performing Episcleral Venus Pressure (EVP) measurement (applicable to 1 site only)
Systemic:
- Clinically significant abnormalities within 6 weeks prior to screening
- Clinically significant systemic disease
- Participation in any investigational study within 60 days prior to screening
- Use of systemic medication that could have an effect on intraocular pressure within 30 days prior to screening
- Women of childbearing potential who were pregnant, nursing, planning a pregnancy, or not using a medically acceptable form of birth control
Data sourced from ClinicalTrials.gov (NCT03233308). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.