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

Phase 4

Waitlist Available

Research Sponsored by Bausch & Lomb Incorporated

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 1, 3, and 5 hours post-instillation at day 1 and 12, 16, and 20 hours post-instillation at day 8

Awards & highlights

Drug Has Already Been Approved

Pivotal Trial

Summary

This trial is testing an eye drop medication called latanoprostene bunod on people with high eye pressure. The goal is to see how well it lowers eye pressure by improving fluid drainage and reducing vein pressure. Participants will use the medication in one eye to compare results. Latanoprostene bunod is a newer treatment related to latanoprost, which has been widely studied for its efficacy in lowering eye pressure in glaucoma patients.

Eligible Conditions

Ocular Hypertension

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 1, 3, and 5 hours post-instillation at day 1 and 12, 16, and 20 hours post-instillation at day 8

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 1, 3, and 5 hours post-instillation at day 1 and 12, 16, and 20 hours post-instillation at day 8

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 1, 3, and 5 hours post-instillation at day 1 and 12, 16, and 20 hours post-instillation at day 8 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change From Baseline in Diurnal (Daytime) EVP at Days 1 and 8

Change From Baseline in Diurnal (Daytime) Trabecular Outflow Facility at Days 1 and 8

Change From Baseline in Episcleral Venous Pressure (EVP) at Intervals on Days 1 and 8

+1 more

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Latanoprostene BunodExperimental Treatment1 Intervention

Participants will receive LBN ophthalmic solution 0.024% in the applicable eye identified during randomization. The first dose will be instilled in the morning (AM) at approximately 11 AM on Day 1 and the remaining 6 doses will be instilled once per day in the evening at approximately 8 PM.

Group II: PlaceboPlacebo Group1 Intervention

Participants will receive Renu MultiPlus Lubricating and Rewetting Drops (placebo) in the applicable eye identified during randomization. The first dose will be instilled in the morning (AM) at approximately 11 AM on Day 1 and the remaining 6 doses will be instilled once per day in the evening at approximately 8 PM.

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