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

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
A Single-Arm, Multicenter, Open-Label Study Evaluating the Long-Term Safety of Latanoprostene Bunod Ophthalmic Solution 0.024%, in Japanese Subjects With Open-Angle Glaucoma or Ocular Hypertension

Conditions
-----------------
Glaucoma, Ocular Hypertension

Intervention / Treatment
-----------------
* Drug: Latanoprostene bunod


Participation Criteria
=================
Eligibility Criteria
-----------------
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).

Ages Eligible for Study
-----------------
Minimum Age: 20 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

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>Latanoprostene bunod 0.024% instilled into the eye once daily (QD) over a 1-year treatment period. | Drug: Latanoprostene bunod<br> <br> * Other names: BOL-303259-X;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Intraocular Pressure | Change from baseline in intraocular pressure (IOP) following treatment with latanoprostene bunod 0.024% (instilled QD in the evening) with IOP assessed every 4 weeks from Week 4 to Week 52. | Baseline and week 4,8,12,16,20,24,28,32,36,40,44,48,52 | 
| Clinical Safety | Ocular adverse events reported over one year of once daily dosing of latanoprostene bunod 0.024%. Below is the percentage of subjects with >/=1 ocular AE Specifics of AEs are captured in the AE section. | 1 year |