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

Phase 3

Completed

• Conditions: Open-angle Glaucoma; Ocular Hypertension
• Interventions: Drug: AR-13324 Ophthalmic Solution 0.02%; Drug: Timolol maleate Ophthalmic Solution 0.5% BID; Drug: AR-13324 Ophthalmic Solution 0.02% BID; Other: Placebo

• Registration Number: NCT02207621
• Lead Sponsor: Aerie Pharmaceuticals

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2014-07
• Study First Submitted: 2014-07-31
• Study First Submitted QC: 2014-07-31
• Study First Posted: 2014-08-04
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Disposition First Submitted: 2016-07-11
• Disposition First Submitted QC: 2016-07-11
• Disposition First Posted: 2016-07-13
• Status Verified: 2018-01
• Results First Submitted: 2018-01-17
• Results First Submitted QC: 2018-03-09
• Last Update Submitted: 2018-03-09
• Results First Posted: 2018-04-06
• Last Update Posted: 2018-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 756

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AR-13324 Ophthalmic Solution 0.02% & placebo	AR-13324 Ophthalmic Solution 0.02%	1 drop AR-13324 in the evening (PM) \& 1 drop placebo in the morning (AM) in both eyes (OU)
AR-13324 Ophthalmic Solution 0.02% & placebo	Placebo	1 drop AR-13324 in the evening (PM) \& 1 drop placebo in the morning (AM) in both eyes (OU)
Timolol maleate Ophthalmic Solution 0.5% BID	Timolol maleate Ophthalmic Solution 0.5% BID	1 drop twice daily (BID) in the morning (AM) and evening (PM) in both eyes (OU)
AR-13324 Ophthalmic Solution 0.02% BID	AR-13324 Ophthalmic Solution 0.02% BID	1 drop AR-13324 twice daily (BID) in the morning (AM) and evening (PM) in both eyes (OU)

Primary Outcome Measures

Name	Time	Method
Intraocular Pressure (IOP)	3 months	The primary efficacy outcome is mean intraocular pressure (IOP)

Secondary Outcome Measures

Name	Time	Method
Extent of Exposure	12 Months	Exposure to study medication in days for all treatment groups

Trial Locations

Locations (1)

Aerie Pharmaceuticals; 🇺🇸 Bedminster, New Jersey, United States