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

• Status: Completed
• Trial end date: 2015-04-14
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bausch & Lomb Incorporated
• Treatments: Ophthalmic Solutions

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).