NCT02207491
Completed
Phase 3
A Double-masked, Randomized, Multi-center, Active-controlled, Parallel, 3-month Study Assessing the Safety and Ocular Hypotensive Efficacy of AR-13324 Ophthalmic Solution, 0.02% Compared to Timolol Maleate Ophthalmic Solution, 0.5% in Patients With Elevated Intraocular Pressure
Aerie Pharmaceuticals1 site in 1 country411 target enrollmentJuly 2014
Overview
- Phase
- Phase 3
- Intervention
- AR-13324 Ophthalmic Solution 0.02%
- Conditions
- Ocular Hypertension
- Sponsor
- Aerie Pharmaceuticals
- Enrollment
- 411
- Locations
- 1
- Primary Endpoint
- Intraocular Pressure (IOP)
- Status
- Completed
- Last Updated
- 8 years ago
Overview
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%
Investigators
Eligibility Criteria
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%
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
Timolol maleate Ophthalmic Solution 0.5% BID
1 drop Timolol maleate twice daily (BID) in the morning (AM) \& evening (PM) in both eyes (OU)
Intervention: Timolol maleate Ophthalmic Solution 0.5% BID
Outcomes
Primary Outcomes
Intraocular Pressure (IOP)
Time Frame: 3 months
The primary efficacy outcome is mean IOP
Secondary Outcomes
- Extent of Exposure(3 months)
Study Sites (1)
Loading locations...
Similar Trials
Completed
Phase 3
Double-masked Study of Netarsudil (AR-13324) Ophthalmic Solution in Subjects With Glaucoma or Ocular HypertensionOpen-angle GlaucomaOcular HypertensionNCT02558374Aerie Pharmaceuticals708
Completed
Phase 3
Evaluation of Netarsudil (AR-13324) Ophthalmic Solution in Patients With Glaucoma and Ocular HypertensionOcular HypertensionOpen-angle GlaucomaNCT02207621Aerie Pharmaceuticals756
Completed
Phase 2
Study of Netarsudil Ophthalmic Solution in Japanese/Japanese-American Subjects With Open-angle Glaucoma or Ocular HypertensionPrimary Open Angle Glaucoma or Ocular HypertensionNCT03310580Aerie Pharmaceuticals42
Completed
Phase 2
Study Assessing Safety and Efficacy of PG324 Ophthalmic Solution in Patients With Elevated Intraocular PressureOpen Angle GlaucomaOcular HypertensionNCT02057575Aerie Pharmaceuticals298
Completed
Phase 3
Study of Netarsudil (AR-13324) Ophthalmic Solution in Patients With Glaucoma or Ocular HypertensionOcular HypertensionGlaucomaNCT02246764Aerie Pharmaceuticals93