NCT04140279

A Study to Evaluate the Effect of Latanoprostene Bunod Ophthalmic Solution 0.024% on Episcleral Venous Pressure and Outflow Facility in Participants With Ocular Hypertension

Effect of Latanoprostene Bunod Ophthalmic Solution 0.024% on Episcleral Venous Pressure and Outflow Facility in Ocular Hypertensive Subjects

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Bausch & Lomb Incorporated · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to determine the effect of latanoprostene bunod (LBN) ophthalmic solution 0.024% (a single dose and 7 days of once daily \[QD\] dosing) on 2 aspects of aqueous humor (AqH) dynamics (episcleral venous pressure \[EVP\] and outflow facility) in participants with ocular hypertension (OHT).

Detailed description

All participants will receive both the investigational (LBN ophthalmic solution 0.024%) and placebo treatments, with 1 eye receiving LBN 0.024% and the contralateral eye receiving placebo. Each participant will be randomized as to which eye (right or left) will receive LBN 0.024% versus placebo. All participants will undergo a minimum 14-day to maximum 42-day washout period prior to the start of study drug administration.

Conditions

• Ocular Hypertension

Interventions

Type	Name	Description
DRUG	Latanoprostene Bunod	Ophthalmic solution
DRUG	Placebo	Ophthalmic solution, no active ingredient.

Timeline

• Start date: 2022-05-13
• Primary completion: 2023-08-01
• Completion: 2023-08-01
• First posted: 2019-10-25
• Last updated: 2024-03-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study