NCT03310580
Completed
Phase 2
A Prospective, Double-masked, Randomized, Multicenter, Placebo-controlled, Parallel-group Study Assessing the Safety and Ocular Hypotensive Efficacy and Optimum Concentration to be Used Clinically of Netarsudil Ophthalmic Solution in Japanese/Japanese-American Subjects With Open-angle Glaucoma or Ocular Hypertension in the United States
Aerie Pharmaceuticals39 sites in 1 country42 target enrollmentNovember 15, 2017
Overview
- Phase
- Phase 2
- Intervention
- AR-13324 Ophthalmic Solution 0.02%
- Conditions
- Primary Open Angle Glaucoma or Ocular Hypertension
- Sponsor
- Aerie Pharmaceuticals
- Enrollment
- 42
- Locations
- 39
- Primary Endpoint
- Mean Diurnal IOP (Intraocular Pressure) (mmHg)
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
To test the safety and effectiveness of AR-13324 0.02% and 0.04% ophthalmic solution relative to placebo in Japanese/Japanese-American subjects with open-angle glaucoma or ocular hypertension in US.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Must be 18 years or older
- •Be of Japanese ethnicity within the 2nd generation defined as (a) 1st generation born in Japan, immigrated to US and (b) 2nd generation - parents are 1st generation and patient was born in US as an American citizen
- •Diagnosis of open-angle glaucoma or ocular hypertension in both eyes
- •Medicated intraocular pressure \>/= 15 mmHg and \< 30 mmHg in both eyes at screening
- •OAG eyes - unmedicated IOP \>/= 15 mmHg and \< 35 mmHg at 2 qualification visits at 08:00, 10:00 and 16:00
- •OHT eyes - unmedicated IOP \>/= 22 mmHg and \< 35mmHg at 08:00, 10:00 and 16:00
- •Best corrected visual acuity + 1.0 logMAR or better by ETDRS in each eye
- •Able to give signed informed consent and follow instructions
Exclusion Criteria
- •Clinically significant ocular disease
- •Pseudoexfoliation or pigment dispersion component glaucoma, history of angle closure glaucoma or narrow angles
- •Intraocular pressure \>/=35 mmHg in either eye
- •Ocular hyperemia score of moderate (+2) at qualification visit #2
- •Previous glaucoma intraocular surgery
- •Refractive surgery in either eye
- •Ocular injury within 6 months prior to screening or ocular surgery or non-refractive laser treatment within 3 months prior to screening
- •Recent or current ocular infection or inflammation in either eye
- •Use of ocular medication in either eye of any kind within 30 days of screening and throughout the study
- •Mean central corneal thickness \> 620 µm in either eye
Arms & Interventions
AR-13324 Ophthalmic Solution 0.02%
Topical sterile ophthalmic solution; 1 drop daily to each eye for 28 days
Intervention: AR-13324 Ophthalmic Solution 0.02%
AR-13324 Ophthalmic Solution 0.04%
Topical sterile ophthalmic solution; 1 drop daily to each eye for 28 days
Intervention: AR-13324 Ophthalmic Solution 0.04%
Placebo Comparator
Topical sterile ophthalmic solution; 1 drop daily to each eye for 28 days
Intervention: AR-13324 Ophthalmic Solution Placebo
Outcomes
Primary Outcomes
Mean Diurnal IOP (Intraocular Pressure) (mmHg)
Time Frame: 28 Days
Mean diurnal intraocular pressure (IOP) at week 4, measured by Goldman Applanation Tonometry (GAT).
Secondary Outcomes
- Extent of Exposure(28 Days)
Study Sites (39)
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