Clinical trial NCT01895985: Efficacy of Latanoprostene Bunod in Lowering Intraocular Pressure in Japanese Healthy Male Volunteers
Official title: A Single-Center, Open-Label Study Evaluating the Efficacy of Latanoprostene Bunod Ophthalmic Solution 0.024%, in Lowering Intraocular Pressure Over a 24-Hour Period in Japanese Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Intraocular Pressure
Lead sponsor: Bausch & Lomb Incorporated
Sponsor class: INDUSTRY
First posted: 2013-07-11
Enrollment: 24
Sex: MALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.

Primary outcomes:
measure: intraocular pressure (IOP)
timeFrame: Visit 3 (Day 14/15)
Secondary outcomes:
measure: Blood levels following a single dose
timeFrame: 12 hours
measure: Blood levels following multiple dosing
timeFrame: 14 days
Other outcomes:
Locations:
city: Madison
country: United States
facility: Bausch & Lomb Incorporated
state: New Jersey
Study officials:
affiliation: Bausch & Lomb Incorporated
name: Quintus Ngumah, OD, PhD
role: STUDY_DIRECTOR
References:
citation: Araie M, Sforzolini BS, Vittitow J, Weinreb RN. Evaluation of the Effect of Latanoprostene Bunod Ophthalmic Solution, 0.024% in Lowering Intraocular Pressure over 24 h in Healthy Japanese Subjects. Adv Ther. 2015 Nov;32(11):1128-39. doi: 10.1007/s12325-015-0260-y. Epub 2015 Nov 12.