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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01895985

Acronym

KRONUS

Enrollment

Registered

2013-07-11

Start date

2013-07-31

Completion date

2013-10-31

Last updated

2018-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intraocular Pressure

Brief summary

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.

Interventions

DRUGLatanoprostene bunod

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

20 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
intraocular pressure (IOP)	Visit 3 (Day 14/15)	Efficacy of latanoprostene bunod dosed QD in reducing IOP from baseline. IOP to be measured at multiple time points at visit 3.

Secondary

Measure	Time frame	Description
Blood levels following a single dose	12 hours	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.
Blood levels following multiple dosing	14 days	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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 15, 2026