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Evaluation of Netarsudil (AR-13324) Ophthalmic Solution in Patients With Glaucoma and Ocular Hypertension | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Evaluation of Netarsudil (AR-13324) Ophthalmic Solution in Patients With Glaucoma and Ocular Hypertension

A Double-masked, Randomized, Multi-center, Active-controlled, Parallel, 12-month Study Assessing the Safety and Ocular Hypotensive Efficacy of AR-13324 Ophthalmic Solution, 0.02% q.d. and b.i.d. Compared to Timolol Maleate Ophthalmic Solution, 0.5% b.i.d. in Patients With Elevated Intraocular Pressure

NCT02207621•Aerie Pharmaceuticals

View on ClinicalTrials.gov

Summary

Evaluation of the ocular hypotensive efficacy and safety of Netarsudil (AR-13324) Ophthalmic Solution compared to Timolol Maleate Ophthalmic Solution

Eligibility

Age

0 - 99 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. 0-2 years of age and 18 years or greater
•2. Diagnosis of open angle glaucoma or ocular hypertension
•3. Unmedicated (post-washout) intraocular pressure (IOP) \>20 mm Hg and \< 27 mm Hg in the study eye at 2 qualification visits
•4. Corrected visual acuity in each eye equivalent to 20/200
•5. Able and willing to give signed informed consent (parent or guardian consent for pediatric patient) and follow study instructions

Exclusion Criteria

•Ophthalmic:
•1. Glaucoma: pseudoexfoliation or pigment dispersion component, history of angle closure, or narrow angles. Note: Previous laser peripheral iridotomy is NOT acceptable.
•2. Intraocular pressure ≥27 mm Hg (unmedicated) in both eyes or use of more than two ocular hypotensive medications within 30 days of screening. Note: fixed dose combinations count as two medications.
•3. Known hypersensitivity to any component of the formulations to be used (benzalkonium chloride, etc.), to topical anesthetics or beta-adrenoceptor antagonists.
•4. Previous glaucoma intraocular surgery or glaucoma laser procedures in either eye
•5. Refractive surgery in either eye.
•6. Ocular trauma in either eye within the six months prior to screening, or ocular surgery or non-refractive laser treatment within the three months prior to screening.
•7. Recent or current evidence of ocular infection or inflammation in either eye. Current evidence of clinically significant blepharitis, conjunctivitis, or a history of herpes simplex or zoster keratitis at screening in either eye.
•8. Ocular medication in either eye of any kind within 30 days of screening.
•9. Clinically significant ocular disease in either eye (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.
+9 more criteria

Locations (1)

Aerie Pharmaceuticals

Bedminster, New Jersey, United States

Key Dates

Start Date

July 1, 2014

Primary Completion Date

March 1, 2016

Completion Date

March 1, 2016

Last Updated

April 6, 2018

Enrollment

756

ACTUAL participants

Conditions

Ocular HypertensionOpen-angle Glaucoma

Interventions

AR-13324 Ophthalmic Solution 0.02%

DRUG

Timolol maleate Ophthalmic Solution 0.5% BID

DRUG

Placebo

OTHER

AR-13324 Ophthalmic Solution 0.02% BID

DRUG

DSLT for Reducing Medication in Glaucoma

NCT07390890

Primary Open Angle GlaucomaOcular Hypertension

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RECRUITINGNA

Direct Selective Laser Trabeculoplasty in Ethnic Chinese Population

NCT05902871

Primary Open Angle GlaucomaOcular Hypertension+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 6, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Evaluation of Netarsudil (AR-13324) Ophthalmic Solution in Patients With Glaucoma and Ocular Hypertension

Inclusion Criteria

Exclusion Criteria

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