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

• Sponsor: Bausch & Lomb Incorporated (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01895985
• Collaborator: (none)
• Enrollment: 24
• Location: 1
• Arm: 1
• Duration (Months): 3
• Patients Per Site Per Month: 7.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Intraocular Pressure	Drug: Latanoprostene bunod	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 24 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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 Start Date: Jul 1, 2013
• Actual Primary Completion Date: Aug 1, 2013
• Actual Study Completion Date: Oct 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Latanoprostene Bunod Participants will instill 1 drop of latanoprostene bunod 0.024% topically into each eye QD in the evening for 14 days.	Drug: Latanoprostene bunod; Other Names: BOL-303259-X

Outcome Measures

Primary Outcome Measures

1. intraocular pressure (IOP) [Visit 3 (Day 14/15)]

   Efficacy of latanoprostene bunod dosed QD in reducing IOP from baseline. IOP to be measured at multiple time points at visit 3.

Secondary Outcome Measures

1. Blood levels following a single dose [12 hours]

   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.

2. Blood levels following multiple dosing [14 days]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Bausch & Lomb Incorporated	Madison	New Jersey	United States	07940

Sponsors and Collaborators

• Bausch & Lomb Incorporated

Investigators

• Study Director: Quintus Ngumah, OD, PhD, Bausch & Lomb Incorporated

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Bausch & Lomb Incorporated
• ClinicalTrials.gov Identifier: NCT01895985
• Other Study ID Numbers: 849
• First Posted: Jul 11, 2013
• Last Update Posted: May 15, 2018
• Last Verified: May 1, 2018

Study Results

No Results Posted as of May 15, 2018