NCT02558374CompletedPhase 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 enrollmentStarted: September 2015Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 708
- Locations
- 1
- Primary Endpoint
- IOP (Intraocular Pressure)
Study Overview
Brief Summary
To evaluate ocular hypotensive efficacy and safety of Netarsudil (AR-13324) Ophthalmic Solution compared to Timolol Maleate Ophthalmic Solution.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •Mean central corneal thickness >620µm at screening
- •Any abnormality preventing reliable applanation tonometry of either eye
- •Clinically significant abnormalities in lab tests at screening
- •Known hypersensitivity or contraindication to beta-adrenoceptor antagonists
- •Clinically significant systemic disease
- •Participation in any investigational study within 60 days prior to screening
- •Used any systemic medication that could have a substantial effect in intraocular pressure within 30 days prior to screening
- •Women who are pregnant, nursing, planning a pregnancy or not using a medically acceptable form of birth control
Arms & Interventions
AR-13324 Ophthalmic Solution 0.02% & placebo
Experimental
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% (Drug)
AR-13324 Ophthalmic Solution 0.02% & placebo
Experimental
1 drop AR-13324 in the evening (PM) & 1 drop placebo in the morning (AM) in both eyes (OU)
Intervention: Placebo (Other)
Timolol Maleate Ophthalmic Solution 0.5% BID
Active Comparator
1 drop twice daily (BID) in the morning (AM) & evening (PM) in both eyes (OU)
Intervention: Timolol Maleate Ophthalmic Solution 0.5% BID (Drug)
Outcomes
Primary Outcomes
IOP (Intraocular Pressure)
Time Frame: 3 months
The primary efficacy outcome is mean IOP
Secondary Outcomes
- Extent of Exposure(6 months)
Investigators
Study Sites (1)
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