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
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AR-13324 Ophthalmic Solution 0.02% | Experimental | Topical sterile ophthalmic solution; 1 drop daily to each eye for 28 days |
|
| AR-13324 Ophthalmic Solution 0.04% | Experimental | Topical sterile ophthalmic solution; 1 drop daily to each eye for 28 days |
|
| Placebo Comparator | Placebo Comparator | Topical sterile ophthalmic solution; 1 drop daily to each eye for 28 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AR-13324 Ophthalmic Solution 0.02% | Drug | Administered to each eye, once daily (QD) in the evening (PM) for 28 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Diurnal IOP (Intraocular Pressure) (mmHg) | Mean diurnal intraocular pressure (IOP) at week 4, measured by Goldman Applanation Tonometry (GAT). | 28 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Extent of Exposure | Exposure to study medication in days for all treatment groups | 28 Days |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Nancy Ramirez-Davis | Aerie Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Eye Center | Chandler | Arizona | 85224 | United States | ||
| Arizona Glaucoma Specialists |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | AR-13324 Ophthalmic Solution 0.02% | AR-13324 Ophthalmic Solution 0.02% : Topical sterile ophthalmic solution; 1 drop daily to each eye for 28 days |
| FG001 | AR-13324 Ophthalmic Solution 0.04% |
| 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 | Jul 17, 2017 | Oct 25, 2019 |
Not provided
Not provided
Not provided
Not provided
Not provided
| AR-13324 Ophthalmic Solution 0.04% | Drug | Administered to each eye, once daily (QD) in the evening (PM) for 28 days |
|
| AR-13324 Ophthalmic Solution Placebo | Drug | Administered to each eye, once daily (QD) in the evening (PM) for 28 days |
|
| Phoenix |
| Arizona |
| 85050 |
| United States |
| Milton M. Hom, OD FAAO FACAAISc | Azusa | California | 91702 | United States |
| Havana Research Institute | Burbank | California | 91506 | United States |
| Global Research Management | Glendale | California | 91204 | United States |
| Southern California Eye Physicians & Surgeons | Los Alamitos | California | 90270 | United States |
| East West Eye Institute | Los Angeles | California | 90013 | United States |
| USC Roski Eye Institute University of Souther California | Los Angeles | California | 90033 | United States |
| Global Research Foundation | Los Angeles | California | 90041 | United States |
| The Eye Research Foundation | Newport Beach | California | 92663 | United States |
| Southern California Eye Physicians Surgeons | Pasadena | California | 91105 | United States |
| North Bay Eye Associates Inc. | Petaluma | California | 94954 | United States |
| Martel Eye | Rancho Cordova | California | 95670 | United States |
| University of California | San Diego | California | 92093 | United States |
| AdvanceMed Clinical Research | San Diego | California | 92122 | United States |
| Glaucoma Center of San Francisco | San Francisco | California | 94105 | United States |
| Samsum Clinic | Santa Barbara | California | 93110 | United States |
| MCB Clinical Research Centers LLC | Colorado Springs | Colorado | 80910 | United States |
| Clayton Eye Clinical Research, LLC | Morrow | Georgia | 30260 | United States |
| Jenkins Eye Care | Honolulu | Hawaii | 96814 | United States |
| Winward Eye Physicians and Eye Surgeons | Kailua | Hawaii | 96704 | United States |
| Island Eye Care, Inc. | Kailua | Hawaii | 96740 | United States |
| They Eye Care Institute | Louisville | Kentucky | 40206 | United States |
| University of Michigan | Ann Arbor | Michigan | 48105 | United States |
| University of Nebraska Medical Center | Omaha | Nebraska | 68198 | United States |
| Emil A. Stein MD Ltd | Las Vegas | Nevada | 89119 | United States |
| AdvanceMed Clinical Research | Las Vegas | Nevada | 89123 | United States |
| New York Eye Infirmary of Mount Sinai | New York | New York | 10003 | United States |
| The Shimmyo Group | New York | New York | 10016 | United States |
| Manhattan Eye Ear and Throat Hospital | New York | New York | 10065 | United States |
| Optimed Research | Marysville | Ohio | 43040 | United States |
| Glaucoma Consultants and Center for Eye Research, PA | Mt. Pleasant | South Carolina | 29464 | United States |
| University Eye Specialists | Maryville | Tennessee | 37803 | United States |
| VRF Eye Speciality Group | Memphis | Tennessee | 38120 | United States |
| Lake Travis Eye and Laser Center | Lakeway | Texas | 78734 | United States |
| DCT - Shah Research LLC dba Discovery Clinical Trials | Mission | Texas | 78572 | United States |
| Round Rock Eye Consultants | Round Rock | Texas | 78681 | United States |
| San Antonio Eye Center | San Antonio | Texas | 78215 | United States |
| R and R Eye Research LLC | San Antonio | Texas | 78229 | United States |
| Emerson Clinical Research Institute | Falls Church | Virginia | 22046 | United States |
AR-13324 Ophthalmic Solution 0.04%: Topical sterile ophthalmic solution; 1 drop daily to each eye for 28 days
| FG002 | Placebo Comparator | AR-13324 Ophthalmic Solution Placebo: Topical sterile ophthalmic solution; 1 drop daily to each eye for 28 days |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Intent to Treat Population (ITT)
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | AR-13324 Ophthalmic Solution 0.02% | AR-13324 Ophthalmic Solution 0.02%: Topical sterile ophthalmic solution; 1 drop daily to each eye for 28 days |
| BG001 | AR-13324 Ophthalmic Solution 0.04% | AR-13324 Ophthalmic Solution 0.04%: Topical sterile ophthalmic solution; 1 drop daily to each eye for 28 days |
| BG002 | Placebo Comparator | AR-13324 Ophthalmic Solution Placebo: Topical sterile ophthalmic solution; 1 drop daily to each eye for 28 days |
| BG003 | 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, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | 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 | Mean Diurnal IOP (Intraocular Pressure) (mmHg) | Mean diurnal intraocular pressure (IOP) at week 4, measured by Goldman Applanation Tonometry (GAT). | Intent to treat (ITT) population | Posted | Mean | Standard Error | mmHg | 28 Days |
|
|
| |||||||||||||||||||||||||||||||
| Secondary | Extent of Exposure | Exposure to study medication in days for all treatment groups | Exposure to study medication in days for all treatment groups | Posted | Mean | Standard Deviation | Days | 28 Days |
|
|
Adverse Event data was collected during the course of the study of 28 days and after 30 days safety follow up
Safety population is defined as all randomized subjects who have received at least 1 dose of study medication.
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 | AR-13324 Ophthalmic Solution 0.02% | AR-13324 Ophthalmic Solution 0.02%: Topical sterile ophthalmic solution; 1 drop daily to each eye for 28 days | 0 | 15 | 0 | 15 | 10 | 15 |
| EG001 | AR-13324 Ophthalmic Solution 0.04% | AR-13324 Ophthalmic Solution 0.04%: Topical sterile ophthalmic solution; 1 drop daily to each eye for 28 days | 0 | 14 | 0 | 14 | 11 | 14 |
| EG002 | Placebo Comparator | AR-13324 Ophthalmic Solution Placebo: Topical sterile ophthalmic solution; 1 drop daily to each eye for 28 days | 0 | 12 | 0 | 12 | 3 | 12 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conjunctival hyperaemia | Eye disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Eye Pruritus | Eye disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Conjunctival hemorrhage | Eye disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA 20.0 | Systematic Assessment |
| |
| vision blurred | Eye disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Eyelid margin crusting | Eye disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Eyelids pruritus | Eye disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Instillation site foreign body sensation | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Instillation site pain | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Viral Upper Respiratory Tract Infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Pain in Extremity | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nancy Ramirez-Davis, Director, Global Clinical Operations | Aerie Pharmaceuticals, Inc. | (908) 947-3543 | nramirez@aeriepharma.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 30, 2018 | Oct 25, 2019 | SAP_001.pdf |
| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| D009798 | Ocular Hypertension |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D005128 | Eye Diseases |
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Japanese 2nd Generation |
|
|