Long-Term Safety of Latanoprostene Bunod Ophthalmic Solution 0.024% in Japanese Subjects With OAG or OHT
Condition: Glaucoma; Ocular Hypertension
MeSH terms: Glaucoma; Ocular Hypertension; Hypertension
Intervention: Latanoprostene bunod
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 130.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No

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.
    

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).