Efficacy and Systemic Safety of Netarsudil 0.01%, 0.02%, 0.04% Relative to Placebo in Subjects With Open-angle Glaucoma or Ocular Hypertension in Japan
- Sponsor
- Aerie Pharmaceuticals
- Study ID
- NCT03844945
- Phase
- PHASE2
- Status
- Completed
Conditions
- Ocular Hypertension
- Open Angle Glaucoma
Eligibility Criteria
- Sex
- ALL
- Age
- 20 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Netarsudil Ophthalmic Solution 0.01% — DRUGTopical sterile ophthalmic solution
- Netarsudil Ophthalmic Solution 0.02% — DRUGTopical sterile ophthalmic solution
- Netarsudil Ophthalmic Solution 0.04% — DRUGTopical sterile ophthalmic solution
- Netarsudil Ophthalmic Solution Placebo — OTHERTopical sterile ophthalmic solution
Study Details
Test ocular hypotensive efficacy and systemic safety of netarsudil 0.01%, 0.02%, 0.04% relative to placebo in subjects with open-angle glaucoma or ocular hypertension in Japan
Key Dates
- Start date
- Mar 19, 2019
- Status verified
- Sep 2020
- Primary completion
- Sep 19, 2019
- Completion
- Sep 19, 2019
Study Design
- Enrollment
- 215 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Netarsudil Ophthalmic Solution 0.01%1 drop daily into each eye in the evening for 28 days
- Experimental: Netarsudil Ophthalmic Solution 0.02%1 drop daily into each eye in the evening for 28 days
- Experimental: Netarsudil Ophthalmic Solution 0.04%1 drop daily into each eye in the evening for 28 days
- Placebo Comparator: Netarsudil Ophthalmic Solution Placebo1 drop daily into each eye in the evening for 28 days
Primary Outcome Measure
Intraocular Pressure (IOP) [ Time Frame: 29 Days ]
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