Status:
COMPLETED
Efficacy of Latanoprostene Bunod in Lowering Intraocular Pressure in Japanese Healthy Male Volunteers
Lead Sponsor:
Bausch & Lomb Incorporated
Conditions:
Intraocular Pressure
Eligibility:
MALE
20+ years
Phase:
PHASE1
Brief 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.
Eligibility Criteria
Inclusion
- Participants with a corrected decimal visual acuity (VA) of 0.5 or better in both eyes.
Exclusion
- 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.
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2013
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT01895985
Start Date
July 1 2013
End Date
October 1 2013
Last Update
May 15 2018
Active Locations (1)
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1
Bausch & Lomb Incorporated
Madison, New Jersey, United States, 07940