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The objective of this study is to evaluate the effect of latanoprostene bunod dosed once daily (QD) in reducing intraocular pressure (IOP) measured over a 24-hour period in healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Latanoprostene Bunod | Experimental | Participants will instill 1 drop of latanoprostene bunod 0.024% topically into each eye QD in the evening for 14 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Latanoprostene bunod | Drug |
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| Measure | Description | Time Frame |
|---|---|---|
| intraocular pressure (IOP) | Efficacy of latanoprostene bunod dosed QD in reducing IOP from baseline. IOP to be measured at multiple time points at visit 3. | Visit 3 (Day 14/15) |
| Measure | Description | Time Frame |
|---|---|---|
| Blood levels following a single dose | The systemic pharmacokinetics (PK) of latanoprostene bunod, latanoprost acid, and Butanediol Mononitrate (BDMN) following a single dose of latanoprostene bunod. blood samples to be collected pre dose, and multiple time points over a 12 hour period. | 12 hours |
| Blood levels following multiple dosing |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Quintus Ngumah, OD, PhD | Bausch & Lomb Incorporated | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bausch & Lomb Incorporated | Madison | New Jersey | 07940 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26563323 | Result | Araie M, Sforzolini BS, Vittitow J, Weinreb RN. Evaluation of the Effect of Latanoprostene Bunod Ophthalmic Solution, 0.024% in Lowering Intraocular Pressure over 24 h in Healthy Japanese Subjects. Adv Ther. 2015 Nov;32(11):1128-39. doi: 10.1007/s12325-015-0260-y. Epub 2015 Nov 12. |
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| ID | Term |
|---|---|
| C568859 | BOL 303259-X |
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The systemic PK of latanoprostene bunod, latanoprost acid and Butanediol Mononitrate (BDMN) following repeated QD dosing of latanoprostene bunod for 14 days. Blood samples to be collected prior to day 14 dose and at multiple time points following dosing over a 12 hour period. |
| 14 days |