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Study Comparing the Effects of Latanoprostene Bunod and Timolol on Retinal Blood Vessel Density and Visual Acuity | Clinical Trials | Clareo Health

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Study Comparing the Effects of Latanoprostene Bunod and Timolol on Retinal Blood Vessel Density and Visual Acuity

A Randomized, Single Center, Masked, Crossover Study Comparing the Effects of Latanoprostene Bunod and Timolol on Retinal Blood Vessel Density and Visual Acuity in Patients With Ocular Hypertension or Primary Open Angle Glaucoma

NCT03931317•University of California, San Diego

View on ClinicalTrials.gov

Summary

The purpose of this research study is to compare the effect of Latanoprostene Bunod and Timolol on eye pressure and blood vessels of the back of the eye.

Detailed Description

The primary objective of this clinical investigation is to compare the difference in change in retinal blood vessel density (peripapillary and macular) between latanoprostene bunod (LBN) ophthalmic solution 0.024% dosed once daily (QD) and timolol maleate 0.5% dosed twice daily (BID) in subjects with OAG or OHT and in normal subjects. Primary Efficacy Endpoint The primary efficacy endpoint for this study is the change in retinal blood vessel density (peripapillary and macular) between treatment groups after 4 weeks of treatment (Visit 4 \[Week 5\] and Visit 6 \[Week 11\]). Secondary Efficacy Endpoints The secondary efficacy endpoint for this study is change in best-corrected visual acuity (BCVA). Safety Endpoints The safety endpoint for this study is the incidence of ocular and systemic adverse events (AEs).

Eligibility

Age

40 - 90 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Subjects must be between 40 to 90 years of age, inclusive, on the date the Informed Consent Form (ICF) is signed and with the capacity to provide voluntary informed consent.
•Subjects must be able to read, understand, and provide written informed consent on the Institutional Review Board (IRB) approved ICF. Only English speakers will be enrolled.
•Subjects who are able and willing to comply with all treatment and follow-up/study procedures.
•Female subjects who are not of childbearing potential or female subjects who have a negative urine pregnancy test result at Visit 1 (Screening) and Visit 3 (Randomization, Week 1).
•Females of childbearing potential, defined as a female who is fertile following menarche, must have a negative serum pregnancy test at screening and agree to use an acceptable method of contraception throughout their participation in the study.

Exclusion Criteria

•Subjects participating in any drug or device clinical investigation within 30 days prior to Visit 1 (Screening) for subjects requiring a washout period, or 30 days prior to Visit 3 (Randomization, Week 1) for treatment naïve subjects.
•Subjects who anticipate participating in any other drug or device clinical investigation within the duration of this study.
•Subjects with a history or presence of chronic generalized systemic disease that the Investigator feels might increase the risk to the subject or confound the results of the study.
•Female subjects who are pregnant or breastfeeding.
•Subjects currently taking systemic β-adrenergic antagonists.
•Subjects with an anticipated need to initiate or modify medication (systemic or topical) that is known to affect IOP (eg, α-adrenergic agonists, calcium channel blockers, angiotensin converting enzyme \[ACE\] inhibitors, and angiotensin II receptor blockers).
•Subjects with known hypersensitivity or contraindications to latanoprostene bunod or any of the ingredients in the study drugs.
•Subjects with known hypersensitivity or contraindications to timolol maleate or other -adrenergic receptor antagonists or any of the ingredients in the study drugs.
•Subjects who are expected to require treatment with ocular or systemic corticosteroids.
•Subjects who are in need of any other topical or systemic treatment of OAG or OHT.
+16 more criteria

Locations (1)

UCSD Shiley Eye Institute

La Jolla, California, United States

Key Dates

Start Date

December 3, 2018

Primary Completion Date

May 20, 2021

Completion Date

March 1, 2023

Last Updated

August 29, 2023

Enrollment

ACTUAL participants

Conditions

OAG - Open-Angle GlaucomaOHT - Ocular Hypertension

Interventions

Latanoprostene bunod 0.024% QD

DRUG

Timolol maleate 0.5% BID

DRUG

Effects of Netarsudil and Timolol on Retinal Blood Vessel Density and Visual Acuity

NCT04064918

OAG - Open-Angle GlaucomaOHT - Ocular Hypertension

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 29, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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