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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
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
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 moreTrial 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
256 Previous Clinical Trials
58,090 Total Patients Enrolled
10 Trials studying Ocular Hypertension
2,666 Patients Enrolled for Ocular Hypertension
Anya LoncaricStudy DirectorBausch & Lomb Incorporated
39 Previous Clinical Trials
20,663 Total Patients Enrolled
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