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Prostaglandin Analog

Latanoprostene Bunod for 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

Study Summary

This trial is testing a new eye drop to see if it can help two aspects of aqueous humor in people with ocular hypertension.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

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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Who is running the clinical trial?

Bausch & Lomb IncorporatedLead Sponsor

251 Previous Clinical Trials

57,416 Total Patients Enrolled

10 Trials studying Ocular Hypertension

2,666 Patients Enrolled for Ocular Hypertension

Anya LoncaricStudy DirectorBausch & Lomb Incorporated

39 Previous Clinical Trials

20,831 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any openings for individuals to participate in this investigation?

"According to the information present on clinicaltrials.gov, this research is actively seeking candidates having been initially posted back in May 13th 2022 and last updated on September 29th of the same year."

Answered by AI

Is this the inaugural research endeavor of its sort?

"Presently, Latanoprostene Bunod is only being studied at a single location in one nation. The drug's inaugural study was conducted by Bausch & Lomb Incorporated in 2022, comprising of 34 participants and reaching its Phase 4 approval stage. Since that time, 18338 trials have been completed successfully."

Answered by AI

Is Latanoprostene Bunod a reliable treatment with minimal side effects?

"The safety of Latanoprostene Bunod is highly rated, receiving a score of 3. This reflects the fact that this medication has been approved for clinical use and Phase 4 trials have been completed."

Answered by AI

How many participants are being observed in this clinical experiment?

"Affirmative, the information available on clinicaltrials.gov indicates that this medical trial is currently seeking participants to enrol. This study commenced at May 13th 2022 and was most recently revised on September 29th 2022; with a target of recruiting 34 patients from only one site."

Answered by AI

Are there any other formal investigations into Latanoprostene Bunod's effectiveness?

"Presently, only 1 clinical trial for Latanoprostene Bunod is actively underway and it remains in Phase 3. This study primarily takes place in Rochester, Minnesota though other sites are conducting trials with this drug too."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2022. "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". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04140279.