NCT02207491CompletedPhase 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 enrollmentStarted: July 2014Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 411
- Locations
- 1
- Primary Endpoint
- Intraocular Pressure (IOP)
Study 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%
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
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 Timolol maleate 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
Intraocular Pressure (IOP)
Time Frame: 3 months
The primary efficacy outcome is mean IOP
Secondary Outcomes
- Extent of Exposure(3 months)
Investigators
Study Sites (1)
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