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Completed

NCT Number: NCT01895985

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

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.

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Key information

Conditions

Intraocular Pressure

Age range

20 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Bausch & Lomb Incorporated

Madison, New Jersey, 07940, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Latanoprostene bunod

Drug

Other names: BOL-303259-X

Primary outcomes

  1. intraocular pressure (IOP)

    Time frame: 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 outcomes

  1. Blood levels following a single dose

    Time frame: 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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Bausch & Lomb Incorporated

Industry

Registry information

Official study 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

Acronym: KRONUS

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Jul 11, 2013
Registry last updated
May 15, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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