Efficacy of Latanoprostene Bunod in Lowering Intraocular Pressure in Japanese Healthy Male Volunteers

• Status: Completed
• Trial end date: 2013-10-01
• Target enrollment: 0
• Participant gender: Male

Summary

The objective of this study is to evaluate the effect of latanoprostene bunod dosed once daily (QD) in reducing intraocular pressure (IOP) measured over a 24-hour period in healthy subjects.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Bausch & Lomb Incorporated

Criteria

Inclusion Criteria:

• Participants with a corrected decimal visual acuity (VA) of 0.5 or better in both eyes.

Exclusion Criteria:

• Subjects with known hypersensitivity or contraindications to latanoprostene bunod, or any of the ingredients in the study drug.

• Subjects with known contraindications to NO treatment.

• Subjects who are unable to discontinue contact lens use at least 7 days prior to Visit 2 (Day 0/1/2) and during the 14 to 15-day study treatment period.

• Subjects who are unable to discontinue the use of all topical ophthalmic medications, including artificial tears, at least 7 days prior to Visit 2 (Day 0/1/2) and during the 14 to 15-day study treatment period.

• Subjects with any condition that prevents reliable applanation tonometry in either eye.

• Subjects with glaucoma in either eye.

• Subjects with any condition that prevents clear visualization of the fundus.

• Subjects who are monocular.

• 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 any intraocular infection or inflammation within 3 months (90 days) prior to Visit 1 (Screening).

• Subjects with a history of ocular laser surgery within the 3 months (90 days) prior to Visit 1 (Screening).

• Subjects with a history of incisional ocular surgery or severe trauma.