Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Netarsudil Ophthalmic Solution 0.01% | Experimental | 1 drop daily into each eye in the evening for 28 days |
|
| Netarsudil Ophthalmic Solution 0.02% | Experimental | 1 drop daily into each eye in the evening for 28 days |
|
| Netarsudil Ophthalmic Solution 0.04% | Experimental | 1 drop daily into each eye in the evening for 28 days |
|
| Netarsudil Ophthalmic Solution Placebo | Placebo Comparator | 1 drop daily into each eye in the evening for 28 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Netarsudil Ophthalmic Solution 0.01% | Drug | Topical sterile ophthalmic solution |
|
| Measure | Description | Time Frame |
|---|---|---|
| Intraocular Pressure (IOP) | Mean diurnal IOP within a treatment by Goldman Applanation Tonometry | 29 Days |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Kenji Aso, M.D., Ph.D. | Aerie Pharmaceuticals Ireland Ltd. (Japan Branch) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nomura Eye Clinic | Ichinomiya-shi | Aichi-ken | Japan | |||
| Shisui ophthalmology clinic |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33629227 | Derived | Araie M, Sugiyama K, Aso K, Kanemoto K, Kothapalli K, Kopczynski C, Senchyna M, Hollander DA. Phase 2 Randomized Clinical Study of Netarsudil Ophthalmic Solution in Japanese Patients with Primary Open-Angle Glaucoma or Ocular Hypertension. Adv Ther. 2021 Apr;38(4):1757-1775. doi: 10.1007/s12325-021-01634-9. Epub 2021 Feb 24. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Prior to enrollment, adult participants were to have a Screening Visit and 2 Qualification Visits to allow for washout of ocular hypotensive medication if needed.
Participants were recruited at 25 clinical trial sites in Japan.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Netarsudil Ophthalmic Solution 0.01% | 1 drop daily into each eye in the evening for 28 days Netarsudil Ophthalmic Solution 0.01%: Topical sterile ophthalmic solution |
| FG001 | Netarsudil Ophthalmic Solution 0.02% |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 6, 2018 | Sep 21, 2020 |
Not provided
Not provided
Not provided
Not provided
Not provided
| Netarsudil Ophthalmic Solution 0.02% | Drug | Topical sterile ophthalmic solution |
|
|
| Netarsudil Ophthalmic Solution 0.04% | Drug | Topical sterile ophthalmic solution |
|
| Netarsudil Ophthalmic Solution Placebo | Other | Topical sterile ophthalmic solution |
|
| Shisui |
| Chiba |
| Japan |
| Nakamori Eye Clinic | Kitakyushu-shi | Fukuoka | Japan |
| Southern TOHOKU Eye Clinic | Koriyama-shi | Fukushima | Japan |
| Kusatsu Eye Clinic | Hiroshima | Hiroshima | Japan |
| Kanamori Eye Clinic | Akashi-shi | Hyōgo | Japan |
| Sameshima Eye Clinic | Kagoshima | Kagoshima-ken | Japan |
| Asahigaoka Ophthalmology | Sendai | Miyagi | Japan |
| Sugao Eye Clinic | Osaka | Osaka | Japan |
| Yubikai Kawaguchi Aozora Eye Clinic | Kawaguchi-shi | Saitama | Japan |
| Hangai Eye Institute | Saitama-shi | Saitama | Japan |
| Omiya Hamada Eye Clinic West Entrance Branch | Saitama-shi | Saitama | Japan |
| Omiya Hamada Eye Clinic | Saitama-shi | Saitama | Japan |
| Shibuya Ophthalmology Clinic | Saitama-shi | Saitama | Japan |
| Yoshimura Eye & Internal Medical Clinic | Mishima | Shiizuoka | Japan |
| Medical Corporation Muramatsu Clinic Muramatsu Eye Clinic | Susono | Shizuoka | Japan |
| Ueda Eye Clinic | Arakawa-ku | Tokyo | Japan |
| Ochanomizu Inoue Eye Clinic | Chiyoda-ku | Tokyo | Japan |
| Kiyosawa Eye Clinic | Koto-Ku | Tokyo | Japan |
| Tamagawa Eye Clinic | Ōta-ku | Tokyo | Japan |
| Seijo Clinic | Setagaya-Ku | Tokyo | Japan |
| Dogenzaka Kato Eye Clinic | Shibuya-ku | Tokyo | Japan |
| Wakabadai Eye Clinic | Shibuya-ku | Tokyo | Japan |
| Hashida Eye Clinic | Shinagawa-Ku | Tokyo | Japan |
| Watanabe Eye Clinic | Shinagawa-Ku | Tokyo | Japan |
1 drop daily into each eye in the evening for 28 days
Netarsudil Ophthalmic Solution 0.02%: Topical sterile ophthalmic solution
| FG002 | Netarsudil Ophthalmic Solution 0.04% | 1 drop daily into each eye in the evening for 28 days Netarsudil Ophthalmic Solution 0.04%: Topical sterile ophthalmic solution |
| FG003 | Netarsudil Ophthalmic Solution Placebo | 1 drop daily into each eye in the evening for 28 days Netarsudil Ophthalmic Solution Placebo: Topical sterile ophthalmic solution |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Randomized Population
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Netarsudil Ophthalmic Solution 0.01% | 1 drop daily into each eye in the evening for 28 days Netarsudil Ophthalmic Solution 0.01%: Topical sterile ophthalmic solution |
| BG001 | Netarsudil Ophthalmic Solution 0.02% | 1 drop daily into each eye in the evening for 28 days Netarsudil Ophthalmic Solution 0.02%: Topical sterile ophthalmic solution |
| BG002 | Netarsudil Ophthalmic Solution 0.04% | 1 drop daily into each eye in the evening for 28 days Netarsudil Ophthalmic Solution 0.04%: Topical sterile ophthalmic solution |
| BG003 | Netarsudil Ophthalmic Solution Placebo | 1 drop daily into each eye in the evening for 28 days Netarsudil Ophthalmic Solution Placebo: Topical sterile ophthalmic solution |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Intraocular Pressure (IOP) | Mean diurnal IOP within a treatment by Goldman Applanation Tonometry | Intent to treat (ITT) population | Posted | Mean | Standard Deviation | mmHg | 29 Days |
|
|
|
|
Ocular/Systemic safety during a 4-week treatment period
Safety population, defined as all randomized subjects who received at least one dose of study drug.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Netarsudil Ophthalmic Solution 0.01% | 1 drop daily into each eye in the evening for 28 days Netarsudil Ophthalmic Solution 0.01%: Topical sterile ophthalmic solution | 0 | 55 | 0 | 55 | 21 | 55 |
| EG001 | Netarsudil Ophthalmic Solution 0.02% | 1 drop daily into each eye in the evening for 28 days Netarsudil Ophthalmic Solution 0.02%: Topical sterile ophthalmic solution | 0 | 54 | 0 | 54 | 27 | 54 |
| EG002 | Netarsudil Ophthalmic Solution 0.04% | 1 drop daily into each eye in the evening for 28 days Netarsudil Ophthalmic Solution 0.04%: Topical sterile ophthalmic solution | 0 | 51 | 0 | 51 | 36 | 51 |
| EG003 | Netarsudil Ophthalmic Solution Placebo | 1 drop daily into each eye in the evening for 28 days Netarsudil Ophthalmic Solution Placebo: Topical sterile ophthalmic solution | 0 | 55 | 0 | 55 | 5 | 55 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conjunctival Hyperemia | Eye disorders | MedDRA (21.1) | Non-systematic Assessment |
| |
| Eye Irritation | Eye disorders | MedDRA/J (21.1) | Systematic Assessment |
| |
| Conjunctival Hemorrhage | Eye disorders | MedDRA/J (21.1) | Systematic Assessment |
| |
| Eye Discharge | Eye disorders | MedDRA/J (21.1) | Systematic Assessment |
| |
| Punctate keratitis | Eye disorders | MedDRA/J (21.1) | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA/J (21.1) | Systematic Assessment |
| |
| Abnormal sensation in eye | Eye disorders | MedDRA/J (21.1) | Systematic Assessment |
| |
| Eye pain | Eye disorders | MedDRA/J (21.1) | Systematic Assessment |
| |
| Visual acuity reduced | Eye disorders | MedDRA/J (21.1) | Systematic Assessment |
| |
| Blepharitis | Eye disorders | MedDRA/J (21.1) | Systematic Assessment |
| |
| Chalazion | Eye disorders | MedDRA/J (21.1) | Systematic Assessment |
| |
| Conjunctival follicles | Eye disorders | MedDRA/J (21.1) | Systematic Assessment |
| |
| Corneal erosion | Eye disorders | MedDRA/J (21.1) | Systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA/J (21.1) | Systematic Assessment |
| |
| Erythema of eyelid | Eye disorders | MedDRA/J (21.1) | Systematic Assessment |
| |
| Iritis | Eye disorders | MedDRA/J (21.1) | Systematic Assessment |
| |
| Keratitis | Eye disorders | MedDRA/J (21.1) | Systematic Assessment |
| |
| Lacrimation increased | Eye disorders | MedDRA/J (21.1) | Systematic Assessment |
| |
| Retinal exudates | Eye disorders | MedDRA/J (21.1) | Systematic Assessment |
| |
| Retinal tear | Eye disorders | MedDRA/J (21.1) | Systematic Assessment |
| |
| Swelling of eyelid | Eye disorders | MedDRA/J (21.1) | Systematic Assessment |
| |
| Trichiasis | Eye disorders | MedDRA/J (21.1) | Systematic Assessment |
| |
| Ulcerative keratitis | Eye disorders | MedDRA/J (21.1) | Systematic Assessment |
| |
| Vernal keratoconjuncitvitis | Eye disorders | MedDRA/J (21.1) | Systematic Assessment |
| |
| Visual acuity reduced transiently | Eye disorders | MedDRA/J (21.1) | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA/J (21.1) | Systematic Assessment |
| |
| Instillation site foreign body sensation | General disorders | MedDRA/J (21.1) | Systematic Assessment |
| |
| Instillation site pain | General disorders | MedDRA/J (21.1) | Systematic Assessment |
| |
| Intraocular pressure increased | Investigations | MedDRA/J (21.1) | Systematic Assessment |
| |
| Corneal abrasion | Injury, poisoning and procedural complications | MedDRA/J (21.1) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA/J (21.1) | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA/J (21.1) | Systematic Assessment |
| |
| Gastritis bacterial | Infections and infestations | MedDRA/J (21.1) | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA/J (21.1) | Systematic Assessment |
| |
| Gingivitis | Infections and infestations | MedDRA/J (21.1) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA/J (21.1) | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA/J (21.1) | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA/J (21.1) | Systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA/J (21.1) | Systematic Assessment |
| |
| Urine leukocyte esterase positive | Investigations | MedDRA/J (21.1) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Urine abnormality | Renal and urinary disorders | MedDRA/J (21.1) | Systematic Assessment |
|
Prior to publishing any trial results, site shall provide the to be published information to the Sponsor for review and obtain written approval at least thirty (30) days in advance of publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Research, Japan | Aerie Pharmaceuticals Ireland Limited, Japan Branch | +81-3-6860-8410 | JapanCS208@aeriepharma.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 16, 2020 | Sep 21, 2020 | SAP_001.pdf |
| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| D009798 | Ocular Hypertension |
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
Not provided
Not provided
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Day 8 |
|
| Day 15 |
|
| Day 29 |
|