Ignite Creation Date:
2025-12-25 @ 4:36 AM
Ignite Modification Date:
2025-12-26 @ 3:38 AM
Study NCT ID:
NCT04064918
Status:
WITHDRAWN
Last Update Posted:
2022-03-31
First Post:
2019-08-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Netarsudil and Timolol on Retinal Blood Vessel Density and Visual Acuity
Sponsor:
University of California, San Diego
Organization:
Study Overview
Official Title:
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
Status:
WITHDRAWN
Status Verified Date:
2022-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Due to COVID-19 related restrictions it was decided to close this study
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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).
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).
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: