Efficacy of Latanoprostene Bunod in Lowering Intraocular Pressure in Japanese Healthy Male Volunteers

Study Overview
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Brief Summary
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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.

Official Title
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A Single-Center, Open-Label Study Evaluating the Efficacy of Latanoprostene Bunod Ophthalmic Solution 0.024%, in Lowering Intraocular Pressure Over a 24-Hour Period in Japanese Healthy Male Volunteers

Conditions
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Intraocular Pressure

Intervention / Treatment
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* Drug: Latanoprostene bunod


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants with a corrected decimal visual acuity (VA) of 0.5 or better in both eyes. Exclusion Criteria: Subjects with known hypersensitivity or contraindications to latanoprostene bunod, or any of the ingredients in the study drug. Subjects with known contraindications to NO treatment. Subjects who are unable to discontinue contact lens use at least 7 days prior to Visit 2 (Day 0/1/2) and during the 14 to 15-day study treatment period. Subjects who are unable to discontinue the use of all topical ophthalmic medications, including artificial tears, at least 7 days prior to Visit 2 (Day 0/1/2) and during the 14 to 15-day study treatment period. Subjects with any condition that prevents reliable applanation tonometry in either eye. Subjects with glaucoma in either eye. Subjects with any condition that prevents clear visualization of the fundus. Subjects who are monocular. Subjects with aphakia in either eye. Subjects with an active corneal disease in either eye. Subjects with severe dry eye in either eye. Subjects with a history/diagnosis of a clinically significant or progressive retinal disease in either eye. Subjects with any intraocular infection or inflammation within 3 months (90 days) prior to Visit 1 (Screening). Subjects with a history of ocular laser surgery within the 3 months (90 days) prior to Visit 1 (Screening). Subjects with a history of incisional ocular surgery or severe trauma.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Latanoprostene Bunod<br>Participants will instill 1 drop of latanoprostene bunod 0.024% topically into each eye QD in the evening for 14 days. | Drug: Latanoprostene bunod<br> <br> * Other names: BOL-303259-X;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |