Study of Netarsudil (AR-13324) in Patients With Elevated Intraocular Pressure
Status: | Completed |
---|---|
Conditions: | High Blood Pressure (Hypertension), Ocular |
Therapuetic Areas: | Cardiology / Vascular Diseases, Ophthalmology |
Healthy: | No |
Age Range: | 18 - 99 |
Updated: | 2/23/2018 |
Start Date: | March 2012 |
End Date: | July 2012 |
A Phase 2, Double-masked, Randomized, Placebo-controlled, Dose-response Study Assessing the Safety and Ocular Hypotensive Efficacy of Three Doses of Netarsudil (AR-13324) Ophthalmic Solution in Patients With Elevated Intraocular Pressure
In this double-masked, vehicle-controlled, dose-response study, subjects will be randomized
to receive Netarsudil (AR-13324) Ophthalmic Solution 0.01%, 0.02%, and 0.04% or its vehicle
(one eye), q.d. (AM) x 7 days. The first dose and last dose will be administered in the
clinic. Ocular safety and ocular hypotensive efficacy will be evaluated in the clinic
throughout the study.
to receive Netarsudil (AR-13324) Ophthalmic Solution 0.01%, 0.02%, and 0.04% or its vehicle
(one eye), q.d. (AM) x 7 days. The first dose and last dose will be administered in the
clinic. Ocular safety and ocular hypotensive efficacy will be evaluated in the clinic
throughout the study.
Inclusion Criteria:
1. 18 years of age or greater. 18 years of age or greater.
2. Diagnosis of open angle glaucoma (OAG) or ocular hypertension (OHT).
3. Unmedicated (post-washout, p.r.n.) IOP ≥ 24 mm Hg in one or both eyes at 08:00 hours,
≥ 21 mm Hg at 10:00, 12:00 and 16:00 hours on post-washout measurement (Visit 1).
4. Corrected visual acuity in each eye +1.0 logMAR or better by ETDRS in each eye
(equivalent to 20/200).
5. Able and willing to give signed informed consent and follow study instructions.
Exclusion Criteria:
Ophthalmic: Either eye
1. Intraocular pressure > 36 mm Hg
2. Known hypersensitivity to any component of the formulation or to topical anesthetics,
(benzalkonium chloride, etc.)
3. Ocular trauma within the past six months, or ocular surgery or laser treatment within
the past three months.
4. Evidence of ocular infection, inflammation, clinically significant blepharitis or
conjunctivitis at baseline (Visit 1), or history of herpes simplex keratitis.
5. Contact lens wear within 30 minutes of instillation of study medication.
6. Ocular medication of any kind within 30 days of Visit 2, with the exception of a)
ocular hypotensive medications (which must be washed out according to the provided
schedule), b) lid scrubs (which may be used prior to, but not after Visit 2) or c)
lubricating drops for dry eye (which may be used throughout the study),
7. Clinically significant ocular disease (e.g. corneal edema, uveitis, severe
keratoconjunctivitis sicca) which might interfere with the study, including
glaucomatous damage so severe that washout of ocular hypotensive medications for one
month is not judged safe (e.g., advanced glaucomatous optic nerve head or visual field
loss).
8. Any abnormality preventing reliable applanation tonometry in either eye. Study eye:
9. Glaucoma: pseudoexfoliation or pigment dispersion component, history of acute
angle-closure glaucoma, or closed or narrow angle upon gonioscopy. Note: Previous
laser peripheral iridotomy is NOT acceptable.
10. Previous glaucoma intraocular surgery or laser procedures such as ALT, SLT or MLT, as
well as refractive procedures such as RK, LASIK, PRK, or collagen cross linking.
11. Central corneal thickness greater than 600 μm.
General/Systemic:
12. Clinically significant abnormalities in laboratory tests at screening, recognizing
that subjects are not fasting at the time of drawing blood.
13. Clinically significant systemic disease (e.g., uncontrolled diabetes, myasthenia
gravis, hepatic, renal, cardiovascular or endocrine disorders) which might interfere
with the study.
14. Participation in any investigational study within the past 30 days.
15. Changes of systemic medication during the study that could have a substantial effect
on IOP within 30 days prior to screening, or anticipated during the study.
16. Due to status of preclinical safety program, 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.
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