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

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

NCT04064918•University of California, San Diego

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Summary

The purpose of this research study is to compare the effect of Netarsudil 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 netarsudil ophthalmic solution 0.02% dosed once daily (QD) and timolol maleate 0.5% dosed twice daily (BID) in subjects with Open Angle Glaucoma (OAG) or Ocular Hypertension (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 \[Week 13\]). 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
•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. Note: Female subjects who have been surgically sterilized (e.g., hysterectomy or bilateral tubal ligation) or who are postmenopausal (defined as total cessation of menses for \> 1 year) will not be considered "female subjects of childbearing potential".

Exclusion Criteria

•Subjects must have a diagnosis of OAG (including pigmentary or pseudoexfoliative) or OHT in 1 or both eyes. Subjects must not have ocular diseases to be included in the normal group.
•Subjects must have a diagnosis of OAG (including pigmentary or pseudoexfoliative) or OHT in 1 or both eyes. Subjects must not have ocular diseases to be included in the normal group.
•Subjects who are treatment-naïve must meet the following Intraocular Pressure (IOP) requirements at Visit 1 (Screening), and pretreated subjects must meet the following IOP requirements at Visit 2 (End of Washout):Intraocular pressure ≥ 20 mmHg in at least 1 eye and ≤ 30 mmHg in both eyes.
•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 B-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 netarsudil or any of the ingredients in the study drugs.
+19 more criteria

Key Dates

Start Date

December 1, 2021

Primary Completion Date

October 1, 2022

Completion Date

January 1, 2023

Last Updated

March 31, 2022

Conditions

OAG - Open-Angle GlaucomaOHT - Ocular Hypertension

Interventions

Netarsudil 0.02% QD

OTHER

Timolol maleate 0.5% BID

OTHER

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

NCT03931317

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: March 31, 2022Data 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.

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