Long-Term Safety of Latanoprostene Bunod Ophthalmic Solution 0.024% in Japanese Subjects With OAG or OHT

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-05

Study Completion Date

2015-04-14

Brief Summary

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The objective of this study is to demonstrate the clinical safety of latanoprostene bunod 0.024% once daily (QD) over a 1-year treatment period.

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Detailed Description

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Conditions

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Glaucoma Ocular Hypertension

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

Latanoprostene bunod 0.024% instilled into the eye once daily (QD) over a 1-year treatment period.

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

* Subjects must have a diagnosis of open angle glaucoma (OAG) (including normal-tension glaucoma \[NTG\],pigmentary or pseudoexfoliative glaucoma), or ocular hypertension (OHT) in one or both eyes.
* Subjects must meet the following IOP requirements at Visit 3 (Eligibility, Day 0\[after washout for the subjects already on treatment\]): mean/median IOP ≥15 mmHg and ≤36 mmHg at 10 AM in at least 1 eye; and IOP ≤36 mmHg in both eyes.
* Subjects with a corrected Decimal visual acuity (VA) or a Best-Corrected Decimal Visual Acuity (BCVA) of 0.5 or better in both eyes.

Exclusion Criteria

* Subjects who are unable to discontinue contact lens use during and for 15 minutes following instillation of study drug and during study visits.
* Subjects who are unable to discontinue other eye drop medications such as artificial tears for 15 minutes prior to and 15 minutes after instillation of study drug.
* Subjects with a central corneal thickness greater than 600 μm in either eye.
* Subjects with any condition that prevents reliable applanation tonometry in either eye.
* Subjects with advanced glaucoma with a mean deviation (MD) \< -12 dB, a history of split fixation, or a field loss threatening fixation in either eye.
* Subjects with any condition that prevents clear visualization of the fundus.
* Subjects who are monocular (fellow eye is absent).
* 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 very narrow angles and subjects with angle closure congenital, or secondary glaucoma, and subjects with history of angle closure in either eye.
* Subjects with any intraocular infection or inflammation in either eye within 3 months prior to Visit 1 (Screening).
* Subjects with a history of ocular laser surgery in either eye within the 3 months (90 days) prior to Visit 1 (Screening).
* Subjects with a history of incisional ocular surgery or severe trauma in either eye within 3 months prior to Visit 1 (Screening).

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No