Long-Term Safety of Latanoprostene Bunod Ophthalmic Solution 0.024% in Japanese Subjects With OAG or OHT
| Status: | Completed |
|---|---|
| Conditions: | High Blood Pressure (Hypertension), Ocular |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Ophthalmology |
| Healthy: | No |
| Age Range: | 20 - Any |
| Updated: | 7/27/2018 |
| Start Date: | July 5, 2013 |
| End Date: | April 14, 2015 |
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
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.
0.024% once daily (QD) over a 1-year treatment period.
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).
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