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

Intraocular Pressure Clinical Trial

— KRONUS  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01895985
• Other study ID #: 849
• Status: Completed
• Phase: Phase 1
• Start date: July 2013
• Est. completion date: October 2013

Study information

• Verified date: May 2018
• Source: Bausch & Lomb Incorporated
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: October 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Intraocular Pressure

Intervention

Drug:
• Latanoprostene bunod

Locations

Country	Name	City	State
United States	Bausch & Lomb Incorporated	Madison	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Bausch & Lomb Incorporated

Country where clinical trial is conducted

United States, 

References & Publications (1)

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/s12325-01 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	intraocular pressure (IOP)	Efficacy of latanoprostene bunod dosed QD in reducing IOP from baseline. IOP to be measured at multiple time points at visit 3.	Visit 3 (Day 14/15)
Secondary	Blood levels following a single dose	The systemic pharmacokinetics (PK) of latanoprostene bunod, latanoprost acid, and Butanediol Mononitrate (BDMN) following a single dose of latanoprostene bunod. blood samples to be collected pre dose, and multiple time points over a 12 hour period.	12 hours
Secondary	Blood levels following multiple dosing	The systemic PK of latanoprostene bunod, latanoprost acid and Butanediol Mononitrate (BDMN) following repeated QD dosing of latanoprostene bunod for 14 days. Blood samples to be collected prior to day 14 dose and at multiple time points following dosing over a 12 hour period.	14 days