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Latanoprostene Bunod for Ocular Hypertension

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
Ocular HypertensionLatanoprostene Bunod - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

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

Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

Similar Trials

1
Kinezodianone R hydrochloride
1
QLS-101, 2.0%
1
OTX-TIC high dose Travoprost Intracameral Implant

Study Objectives

4 Primary · 0 Secondary · Reporting Duration: Baseline, 1, 3, and 5 hours post-instillation at Day 1 and 12, 16, and 20 hours post-instillation at Day 8

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

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Similar Trials

1
Kinezodianone R hydrochloride
2
QLS-101, 2.0%
2
OTX-TIC high dose Travoprost Intracameral Implant

Trial Design

2 Treatment Groups

Latanoprostene Bunod
1 of 2
Placebo
1 of 2

Experimental Treatment

Non-Treatment Group

34 Total Participants · 2 Treatment Groups

Primary Treatment: Latanoprostene Bunod · Has Placebo Group · Phase 4

Latanoprostene Bunod
Drug
Experimental Group · 1 Intervention: Latanoprostene Bunod · Intervention Types: Drug
Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, 1, 3, and 5 hours post-instillation at day 1 and 12, 16, and 20 hours post-instillation at day 8

Who is running the clinical trial?

Bausch & Lomb IncorporatedLead Sponsor
237 Previous Clinical Trials
55,384 Total Patients Enrolled
10 Trials studying Ocular Hypertension
2,666 Patients Enrolled for Ocular Hypertension
Anya LoncaricStudy DirectorBausch & Lomb Incorporated
38 Previous Clinical Trials
20,705 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are of childbearing potential and must have a negative urine pregnancy test result at the screening examination and must agree to use an acceptable method of contraception throughout your participation in the study.
The general inclusion criteria are met.
Participants must have a washout period of at least 2 weeks.
You must have a best corrected visual acuity (BCV A) of 20/50 (logMAR +0.4) or better in each eye.
References

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