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

NCT01895985 | Completed Phase 1

• 1 other identifier: 849
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Intraocular Pressure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Blood levels following a single dose

  12 hours

• Blood levels following multiple dosing

  14 days

Study Arms (1)

Latanoprostene Bunod

EXPERIMENTAL

Participants will instill 1 drop of latanoprostene bunod 0.024% topically into each eye QD in the evening for 14 days.

Drug: Latanoprostene bunod

Interventions

Latanoprostene bunod DRUG

Also known as: BOL-303259-X

Latanoprostene Bunod

Eligibility Criteria

• Age: 20 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants with a corrected decimal visual acuity (VA) of 0.5 or better in both eyes.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bausch & Lomb Incorporated: lead

Study Sites (1)

Bausch & Lomb Incorporated

Madison, New Jersey, 07940, United States

Location

Related 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/s12325-015-0260-y. Epub 2015 Nov 12.

  PMID: 26563323 RESULT

MeSH Terms

Interventions

BOL 303259-X

Study Officials

• Quintus Ngumah, OD, PhD

  Bausch & Lomb Incorporated

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2013
• First Posted: July 11, 2013
• Study Start: July 1, 2013
• Primary Completion: August 1, 2013
• Study Completion: October 1, 2013
• Last Updated: May 15, 2018

Record last verified: 2018-05

Locations

US (1)