Phase 3
Completed N=93
Study of Netarsudil (AR-13324) Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension
Source: ClinicalTrials.gov NCT02246764 ↗Enrolled (actual)
93
Serious AEs
2.2%
Results posted
Apr 2018
Primary outcomePrimary: Extent of Exposure — 224.4; 101.8; 314.6 days
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The purpose of this study is to evaluate the ocular and systemic safety of Netarsudil (AR-13324) Ophthalmic Solution, 0.02% q.d. and b.i.d. for 12 months compared to the active comparator Timolol Maleate Ophthalmic Solution, 0.5%.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Extent of Exposure |
224.4; 101.8; 314.6 | — |
Eligibility Criteria
Inclusion Criteria
- 19 years of age or greater.
- Diagnosis of open angle glaucoma (OAG) or ocular hypertension (OHT).
- Unmedicated (post-washout) IOP (Intraocular Pressure) >20 mm Hg and 17 mm Hg and 0.8, severe visual field defect).
- Central corneal thickness in either eye greater than 600 µm at screening.
- Any abnormality in either eye preventing reliable applanation tonometry of either eye.
Systemic:
- Clinically relevant abnormalities (as determined by the investigator) in laboratory tests at screening which may impact the study.
- Known hypersensitivity or contraindication to beta-adrenoceptor antagonists (e.g., chronic obstructive pulmonary disease or bronchial asthma; abnormally low blood pressure or heart rate; second or third degree heart block or congestive heart failure; severe diabetes).
- Clinically significant systemic disease (e.g., uncontrolled diabetes, myasthenia gravis, hepatic, renal, endocrine or cardiovascular disorders) which might interfere with the study.
- Participation in any investigational study within 30 days prior to screening.
- Changes of systemic medication that could have an effect on IOP within 30 days prior to screening, or anticipated during the study.
- Women of childbearing potential who are pregnant, nursing, planning a pregnancy, or not using a medically acceptable form of birth control. An adult woman is considered to be of childbearing potential unless she is one year post-menopausal or three months post-surgical sterilization. All females of childbearing potential must have a negative urine pregnancy test result at the screening examination and must not intend to become pregnant during the study.
Data sourced from ClinicalTrials.gov (NCT02246764). 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.