Double-masked Study of AR-13324 Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension
Phase 3
Completed
- Conditions
- Open-angle GlaucomaOcular Hypertension
- Interventions
- Drug: AR-13324 Ophthalmic Solution 0.02%Other: Placebo
- Registration Number
- NCT02207491
- Lead Sponsor
- Aerie Pharmaceuticals
- Brief Summary
To evaluate the ocular hypotensive efficacy and ocular and systemic safety of AR-13324 Ophthalmic Solution, 0.02% compared to the active comparator Timolol maleate Ophthalmic Solution, 0.5%
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 411
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 Placebo 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 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) Timolol maleate Ophthalmic Solution 0.5% BID Timolol maleate Ophthalmic Solution 0.5% BID 1 drop Timolol maleate twice daily (BID) in the morning (AM) \& evening (PM) in both eyes (OU)
- Primary Outcome Measures
Name Time Method Intraocular Pressure (IOP) 3 months The primary efficacy outcome is mean IOP
- Secondary Outcome Measures
Name Time Method Extent of Exposure 3 months Exposure to study medication in days for all treatment groups.
Trial Locations
- Locations (1)
Aerie Pharmaceuticals
🇺🇸Bedminster, New Jersey, United States