Ignite Creation Date:
2025-12-25 @ 4:27 AM
Ignite Modification Date:
2025-12-26 @ 3:31 AM
Study NCT ID:
NCT05624320
Status:
WITHDRAWN
Last Update Posted:
2024-04-09
First Post:
2022-11-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Using AGN-190584 in Subjects Utilizing Single -Use Daily, Contact Lenses
Sponsor:
Gordon Schanzlin New Vision
Organization:
Study Overview
Official Title:
Improved Near Vision and Intermediate Without Loss of Binocular Distance Vision Using AGN-190584 in Subjects Utilizing Single -Use Daily, Contact Lenses for Distance Vision Correction in Both Eyes
Status:
WITHDRAWN
Status Verified Date:
2022-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Lack of interest
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
AGN-190584 has gone through many clinical trials showing its safety and effectiveness in individuals from 40-55 years of age. There has been no published data on the use of this product in individuals corrected with contact lenses for distance vision. There are many other applications AGN-190584 could be used for and further studies will show the effectiveness for each.
Detailed Description:
The study is a single center open label, single arm study with no control and no randomization. Investigators will enroll 30 presbyopic patients between the ages of 40-55 years old who have undergone successful contact lens fitting in single-use, daily, contact lenses between the spectacle lens powers of -4.00 -to +1.00, in both eyes for best distance correction by the primary investigator. Investigators will measure change in letters read at near and intermediate vision from baseline. Subjects will be required to apply AGN-190584 drops once daily OU. Subjects will be applying the drops on their own every day including the day of visits. During treatment investigators will measure changes in letters read from baseline in intermediate and near vision at the days 7, 14 and 21. These visits will be conducted between 2 and 4 hours after instillation of AGN-190584, with 3 hours being the target time.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: