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
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 756
- Locations
- 1
- Primary Endpoint
- Intraocular Pressure (IOP)
Study Overview
Brief Summary
Evaluation of the ocular hypotensive efficacy and safety of Netarsudil (AR-13324) Ophthalmic Solution compared to Timolol Maleate Ophthalmic Solution
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- — to 99 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
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)
Intervention: AR-13324 Ophthalmic Solution 0.02% (Drug)
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)
Intervention: Placebo (Other)
Timolol maleate Ophthalmic Solution 0.5% BID
1 drop twice daily (BID) in the morning (AM) and evening (PM) in both eyes (OU)
Intervention: Timolol maleate Ophthalmic Solution 0.5% BID (Drug)
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)
Intervention: AR-13324 Ophthalmic Solution 0.02% BID (Drug)
Outcomes
Primary Outcomes
Intraocular Pressure (IOP)
Time Frame: 3 months
The primary efficacy outcome is mean intraocular pressure (IOP)
Secondary Outcomes
- Extent of Exposure(12 Months)