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

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.

Study Overview

• Status: Withdrawn
• Conditions: Presbyopia
• Intervention / Treatment: Drug: AGN-190584

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 Type: Interventional
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: David I Geffen, OD; Phone Number: 18584559950; Email: dgeffen@gwsvision.com
• Study Contact Backup: Name: Garret Pennel, OD; Phone Number: (858) 455-6800; Email: gpennel@gwsvision.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Subjects from age 40-55
• Prescription range: -4.00 - +1.00
• Correctable to 20/25 or better for distance
• Adapted single use contact lens patients
• Subjects able to understand the consent agreement and willing to participate

Exclusion Criteria:

• Non-contact lens wearer
• Previous use of AGN-190584
• Out of age range
• Out of prescription range
• Any corneal abnormality
• Any eye pathology
• Iritis
• Know allergy to pilocarpine

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Drug: AGN-190584; miotic for treatment of presbyopia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The primary endpoint will be changes from baseline in letters read at near without loss of distance acuity (defined as loss of 5 or more letters)	30 days

Secondary Outcome Measures

Outcome Measure	Time Frame
secondary endpoint will be changes in intermediate letters read from baseline	30 days

Collaborators and Investigators

• Sponsor: Gordon Schanzlin New Vision
• Collaborators: AbbVie

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2022
• Primary Completion (Estimated): May 30, 2023
• Study Completion (Estimated): June 30, 2023

Study Registration Dates

• First Submitted: November 14, 2022
• First Submitted That Met QC Criteria: November 14, 2022
• First Posted (Actual): November 22, 2022

Study Record Updates

• Last Update Posted (Actual): April 9, 2024
• Last Update Submitted That Met QC Criteria: April 5, 2024
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: presbyopia
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Presbyopia
• Other Study ID Numbers: Gordon Schanzlin New Vision

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes