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
Not provided
Not provided
The primary objectives of this study are to compare the safety, tolerability, and mean change from baseline in diurnal intraocular pressure (IOP) of ONO-9054 30 µg/mL (0.003%) to latanoprost 0.005% following ocular instillation once every evening for 28 days.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Arm 1 | Experimental | ONO-9054 eye drop solution, 30 µg/mL (0.003%), once daily in both eyes, for 28 days. |
|
| Active Comparator Arm 2 | Active Comparator | Latanoprost eye drop solution, 0.005%, once daily in both eyes for 28 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ONO-9054 | Drug |
| ||
| Latanoprost |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change in diurnal IOP (average of four time points) from baseline | 28 days | |
| Evaluating the safety parameters per protocol | Physical and ocular examinations (tolerability, hyperemia, visual acuity, pupillometry, corneal thickness, aqueous cells and flare), vital signs, and safety laboratory evaluations | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Diurnal IOP | 28 days | |
| Mean change from baseline in IOP at each measured time point | 28 days | |
| Treatment response rates |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Ono Pharmaceutical Co., Ltd. | Ono Pharmaceutical Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Los Angeles Clinical Site | Los Angeles | California | 90048 | United States | ||
| Mission Hills Clinical Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27649982 | Derived | Miller Ellis E, Berlin MS, Ward CL, Sharpe JA, Jamil A, Harris A. Ocular hypotensive effect of the novel EP3/FP agonist ONO-9054 versus Xalatan: results of a 28-day, double-masked, randomised study. Br J Ophthalmol. 2017 Jun;101(6):796-800. doi: 10.1136/bjophthalmol-2016-309023. Epub 2016 Sep 20. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| 28 days |
| Percent change from baseline in IOP at each measured time point | 28 days |
| Mission Hills |
| California |
| 91345 |
| United States |
| Newport Beach Clinical Site | Newport Beach | California | 92663 | United States |
| Pasadena Clinical Site | Pasadena | California | 91105 | United States |
| Petaluma Clinical Site | Petaluma | California | 94954 | United States |
| Morrow Clinical Site | Morrow | Georgia | 30260 | United States |
| Roswell Clinical Site | Roswell | Georgia | 30076 | United States |
| New York Clinical Site | New York | New York | 10029 | United States |
| High Point Clinical Site | High Point | North Carolina | 27262 | United States |
| Cranberry Township Clinical Site | Cranberry Township | Pennsylvania | 16066 | United States |
| Philadelphia Clinical Site | Philadelphia | Pennsylvania | 19104 | United States |
| Austin Clinical Site | Austin | Texas | 78731 | United States |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005902 | Glaucoma, Open-Angle |
| D005901 | Glaucoma |
| D005128 | Eye Diseases |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| C000607345 | propan-2-yl 4-(6-(4-(2,5-difluorophenoxy)-3-hydroxybut-1-en-1-yl)-7-hydroxyoctahydro-2H-cyclopenta(b)oxepin-3-yl)butanoate |
| D000077338 | Latanoprost |
| ID | Term |
|---|---|
| D011461 | Prostaglandins F, Synthetic |
| D011465 | Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |
Not provided
Not provided