Double-masked Study of Netarsudil (AR-13324) Ophthalmic Solution in Subjects With Glaucoma or Ocular Hypertension

Phase 3

Completed

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

• Registration Number: NCT02558374
• Lead Sponsor: Aerie Pharmaceuticals

Brief Summary

To evaluate 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: 2015-09
• Study First Submitted: 2015-09-16
• Study First Submitted QC: 2015-09-23
• Study First Posted: 2015-09-24
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Disposition First Submitted: 2017-12-19
• Disposition First Submitted QC: 2017-12-19
• Disposition First Posted: 2017-12-21
• 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: 708

Inclusion Criteria

1. 18 years of age or older
2. Diagnosis of open angle glaucoma or ocular hypertension in both eyes
3. Post-washout intraocular pressure >20mmHg and <30mmHg in 1 or both eyes at 2 qualification visits
4. Corrected visual acuity equivalent to 20/200
5. Able to give informed consent and follow study instructions

Exclusion Criteria

1. Clinically significant ocular disease
2. Pseudoexfoliation or pigment dispersion component glaucoma, history of angle closure or narrow angles
3. Unmedicated intraocular pressure ≥30mmHg
4. Use of more than 2 ocular hypotensive medications within 30 days of screening
5. Known hypersensitivity to any component of the formulation
6. Previous glaucoma surgery or refractive surgery
7. Ocular trauma within 6 months prior to screening
8. Any ocular surgery or non-refractive laser treatment within 3 months prior to screening
9. Recent or current ocular infection or inflammation in either eye
10. Used ocular medication in either eye of any kind within 30 days of screening
11. Mean central corneal thickness >620µm at screening
12. Any abnormality preventing reliable applanation tonometry of either eye
13. Clinically significant abnormalities in lab tests at screening
14. Known hypersensitivity or contraindication to beta-adrenoceptor antagonists
15. Clinically significant systemic disease
16. Participation in any investigational study within 60 days prior to screening
17. Used any systemic medication that could have a substantial effect in intraocular pressure within 30 days prior to screening
18. Women who are pregnant, nursing, planning a pregnancy or not using a medically acceptable form of birth control

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)
Timolol Maleate Ophthalmic Solution 0.5% BID	Timolol Maleate Ophthalmic Solution 0.5% BID	1 drop twice daily (BID) in the morning (AM) \& evening (PM) 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)

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Extent of Exposure	6 months	Exposure to study medication in days for all treatment groups

Trial Locations

Locations (1)

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