NCT05624320

Using AGN-190584 in Subjects Utilizing Single -Use Daily, Contact Lenses

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• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Gordon Schanzlin New Vision · Academic / Other
• Sex: All
• Age: 40 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Presbyopia

Interventions

Type	Name	Description
DRUG	AGN-190584	miotic for treatment of presbyopia

Timeline

• Start date: 2022-12-01
• Primary completion: 2023-05-30
• Completion: 2023-06-30
• First posted: 2022-11-22
• Last updated: 2024-04-09

Regulatory

• FDA-regulated drug study