Evaluation of Netarsudil (AR-13324) Ophthalmic Solution in Patients With Glaucoma and Ocular Hypertension
Phase 3
Completed
- Conditions
- Open-angle GlaucomaOcular Hypertension
- Interventions
- Drug: AR-13324 Ophthalmic Solution 0.02%Drug: AR-13324 Ophthalmic Solution 0.02% BIDOther: Placebo
- Registration Number
- NCT02207621
- Lead Sponsor
- Aerie Pharmaceuticals
- Brief Summary
Evaluation of the ocular hypotensive efficacy and safety of Netarsudil (AR-13324) Ophthalmic Solution compared to Timolol Maleate Ophthalmic Solution
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 756
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
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) 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) Timolol maleate Ophthalmic Solution 0.5% BID Timolol maleate Ophthalmic Solution 0.5% BID 1 drop twice daily (BID) in the morning (AM) and evening (PM) in both eyes (OU) AR-13324 Ophthalmic Solution 0.02% BID 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)
- Primary Outcome Measures
Name Time Method Intraocular Pressure (IOP) 3 months The primary efficacy outcome is mean intraocular pressure (IOP)
- Secondary Outcome Measures
Name Time Method Extent of Exposure 12 Months Exposure to study medication in days for all treatment groups
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What are the molecular mechanisms by which Netarsudil inhibits Rho kinase and enhances ocular hypotension in glaucoma patients?
How does the efficacy of Netarsudil 0.02% compare to beta-blockers like Timolol in managing open-angle glaucoma and ocular hypertension?
Which biomarkers correlate with intraocular pressure reduction in patients treated with Netarsudil during 12-month trials?
What adverse events are associated with Netarsudil ophthalmic solution in phase 3 trials for ocular hypertension?
Are there combination therapies involving Netarsudil and prostaglandin analogs that improve glaucoma management compared to monotherapy?
Trial Locations
- Locations (1)
Aerie Pharmaceuticals
🇺🇸Bedminster, New Jersey, United States
Aerie Pharmaceuticals🇺🇸Bedminster, New Jersey, United States