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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Study Completion Date

2013-10-31

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.

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Detailed Description

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Conditions

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Intraocular Pressure

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Latanoprostene Bunod

Participants will instill 1 drop of latanoprostene bunod 0.024% topically into each eye QD in the evening for 14 days.

Group Type EXPERIMENTAL

Latanoprostene bunod

Intervention Type DRUG

Interventions

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Latanoprostene bunod

Intervention Type DRUG

Other Intervention Names

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BOL-303259-X

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.

Minimum Eligible Age

20 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes