NCT03844945
Completed
Phase 2
A Prospective, Double-masked, Randomized, Multicenter, Placebo-controlled, Parallel-group Study Assessing the Safety, Ocular Hypotensive Efficacy and Optimum Dose Concentration to be Used Clinically of Netarsudil Ophthalmic Solution in Subjects With Open-angle Glaucoma or Ocular Hypertension in Japan
Aerie Pharmaceuticals25 sites in 1 country215 target enrollmentMarch 19, 2019
Overview
- Phase
- Phase 2
- Intervention
- Netarsudil Ophthalmic Solution 0.04%
- Conditions
- Open Angle Glaucoma
- Sponsor
- Aerie Pharmaceuticals
- Enrollment
- 215
- Locations
- 25
- Primary Endpoint
- Intraocular Pressure (IOP)
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
Test ocular hypotensive efficacy and systemic safety of netarsudil 0.01%, 0.02%, 0.04% relative to placebo in subjects with open-angle glaucoma or ocular hypertension in Japan
Investigators
Eligibility Criteria
Inclusion Criteria
- •Must be 20 years of age or older
- •Diagnosis of open-angle glaucoma (OAG) or ocular hypertension (OHT) in both eyes. (OAG in one eye and OHT in the fellow eye is acceptable)
- •BCVA 0.1 or better in decimal unit using Landolt-C chart or its equivalent
- •Able and willing to give signed informed consent and following study instructions
Exclusion Criteria
- •Clinically significant ocular diseases
- •Pseudoexfoliation or pigment dispersion component glaucoma, history of narrow angle closure glaucoma or narrow angles
- •Previous glaucoma intraocular surgery
- •Refractive surgery in either eye
- •Ocular trauma
- •Ocular infection or inflammation
- •Known hypersensitivity to benzalkonium chloride or excipient of netarsudil ophthalmic solution
- •Cannot demonstrate proper delivery of the eye drop
- •Clinically significant abnormalities in screen lab tests
- •Clinically significant systemic disease
Arms & Interventions
Netarsudil Ophthalmic Solution 0.04%
1 drop daily into each eye in the evening for 28 days
Intervention: Netarsudil Ophthalmic Solution 0.04%
Netarsudil Ophthalmic Solution 0.01%
1 drop daily into each eye in the evening for 28 days
Intervention: Netarsudil Ophthalmic Solution 0.01%
Netarsudil Ophthalmic Solution 0.02%
1 drop daily into each eye in the evening for 28 days
Intervention: Netarsudil Ophthalmic Solution 0.02%
Netarsudil Ophthalmic Solution Placebo
1 drop daily into each eye in the evening for 28 days
Intervention: Netarsudil Ophthalmic Solution Placebo
Outcomes
Primary Outcomes
Intraocular Pressure (IOP)
Time Frame: 29 Days
Mean diurnal IOP within a treatment by Goldman Applanation Tonometry
Study Sites (25)
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 3
Study of Netarsudil (AR-13324) Ophthalmic Solution in Patients With Glaucoma or Ocular HypertensionOcular HypertensionGlaucomaNCT02246764Aerie Pharmaceuticals93
Not yet recruiting
Phase 4
Efficacy and safety of Netarsudil in primary angle closure glaucoma.Health Condition 1: H401- Open-angle glaucomaCTRI/2023/08/056186Maharaja agrasen medical college
Completed
Phase 3
Efficacy and Safety Study of Netarsudil 0.02% Ophthalmic Solution Compared to Ripasudil Hydrochloride Hydrate 0.4% Ophthalmic Solution in Japanese Subjects With Primary Open Angle Glaucoma or Ocular HypertensionPrimary Open Angle GlaucomaOcular HypertensionNCT04620135Aerie Pharmaceuticals245