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

NCT ID: NCT02558374

Last Updated: 2018-04-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 708 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2016-12-31

Brief Summary

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

Conditions

Open-angle Glaucoma; Ocular Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

AR-13324 Ophthalmic Solution 0.02% & placebo

1 drop AR-13324 in the evening (PM) \& 1 drop placebo in the morning (AM) in both eyes (OU)

Group Type: EXPERIMENTAL

AR-13324 Ophthalmic Solution 0.02%

Intervention Type: DRUG

1 drop once daily (QD), PM, OU

Placebo

Intervention Type: OTHER

1 drop QD, AM, OU

Timolol Maleate Ophthalmic Solution 0.5% BID

1 drop twice daily (BID) in the morning (AM) \& evening (PM) in both eyes (OU)

Group Type: ACTIVE_COMPARATOR

Timolol Maleate Ophthalmic Solution 0.5% BID

Intervention Type: DRUG

1 drop BID, AM/PM, OU

Interventions

AR-13324 Ophthalmic Solution 0.02%

1 drop once daily (QD), PM, OU

Intervention Type: DRUG

Timolol Maleate Ophthalmic Solution 0.5% BID

1 drop BID, AM/PM, OU

Intervention Type: DRUG

Placebo

1 drop QD, AM, OU

Intervention Type: OTHER

Other Intervention Names

Netarsudil

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aerie Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Theresa Heah, MD

Role: STUDY_DIRECTOR

Aerie Pharmaceuticals, Inc

Locations

Aerie Pharmaceuticals

Bedminster, New Jersey, United States

Countries

United States

Other Identifiers

AR-13324-CS304

Identifier Type: -

Identifier Source: org_study_id