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

Ocular Hypertension Clinical Trial

Official title:

A Double-masked, Randomized, Multi-center, Active-controlled, Parallel Group, 6-month Study With a 3-month Interim Analysis Assessing the Ocular Hypotensive Efficacy and Safety of AR-13324 Ophthalmic Solution, 0.02% QD Compared to Timolol Maleate Ophthalmic Solution, 0.5% BID in Patients With Elevated Intraocular Pressure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02558374
• Other study ID #: AR-13324-CS304
• Status: Completed
• Phase: Phase 3
• First received: September 16, 2015
• Last updated: March 9, 2018
• Start date: September 2015
• Est. completion date: December 2016

Study information

• Verified date: January 2018
• Source: Aerie Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To evaluate ocular hypotensive efficacy and safety of Netarsudil (AR-13324) Ophthalmic Solution compared to Timolol Maleate Ophthalmic Solution.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 708
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Hypertension
• Ocular Hypertension
• Open-angle Glaucoma

Intervention

Drug:
• AR-13324 Ophthalmic Solution 0.02%
1 drop once daily (QD), PM, OU
• Timolol Maleate Ophthalmic Solution 0.5% BID
1 drop BID, AM/PM, OU

Other:
• Placebo
1 drop QD, AM, OU

Locations

Country	Name	City	State
United States	Aerie Pharmaceuticals	Bedminster	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Aerie Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	IOP (Intraocular Pressure)	The primary efficacy outcome is mean IOP	3 months
Secondary	Extent of Exposure	Exposure to study medication in days for all treatment groups	6 months