NCT02558374
Completed
Phase 3
A Double-masked, Randomized, Multi-center, Active-controlled, Parallel Group, 6-month Study With a 3-month Interim Analysis Assessing the Ocular Hypotensive Efficacy and Safety of AR-13324 Ophthalmic Solution, 0.02% QD Compared to Timolol Maleate Ophthalmic Solution, 0.5% BID in Patients With Elevated Intraocular Pressure
Aerie Pharmaceuticals1 site in 1 country708 target enrollmentSeptember 2015
Overview
- Phase
- Phase 3
- Intervention
- AR-13324 Ophthalmic Solution 0.02%
- Conditions
- Open-angle Glaucoma
- Sponsor
- Aerie Pharmaceuticals
- Enrollment
- 708
- Locations
- 1
- Primary Endpoint
- IOP (Intraocular Pressure)
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
To evaluate ocular hypotensive efficacy and safety of Netarsudil (AR-13324) Ophthalmic Solution compared to Timolol Maleate Ophthalmic Solution.
Investigators
Eligibility Criteria
Inclusion Criteria
- •18 years of age or older
- •Diagnosis of open angle glaucoma or ocular hypertension in both eyes
- •Post-washout intraocular pressure \>20mmHg and \<30mmHg in 1 or both eyes at 2 qualification visits
- •Corrected visual acuity equivalent to 20/200
- •Able to give informed consent and follow study instructions
Exclusion Criteria
- •Clinically significant ocular disease
- •Pseudoexfoliation or pigment dispersion component glaucoma, history of angle closure or narrow angles
- •Unmedicated intraocular pressure ≥30mmHg
- •Use of more than 2 ocular hypotensive medications within 30 days of screening
- •Known hypersensitivity to any component of the formulation
- •Previous glaucoma surgery or refractive surgery
- •Ocular trauma within 6 months prior to screening
- •Any ocular surgery or non-refractive laser treatment within 3 months prior to screening
- •Recent or current ocular infection or inflammation in either eye
- •Used ocular medication in either eye of any kind within 30 days of screening
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 twice daily (BID) in the morning (AM) \& evening (PM) in both eyes (OU)
Intervention: Timolol Maleate Ophthalmic Solution 0.5% BID
Outcomes
Primary Outcomes
IOP (Intraocular Pressure)
Time Frame: 3 months
The primary efficacy outcome is mean IOP
Secondary Outcomes
- Extent of Exposure(6 months)
Study Sites (1)
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