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

NCT ID: NCT05624320

Last Updated: 2024-04-09

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-01
• Study Completion Date: 2023-06-30

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.

Conditions

Presbyopia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

AGN-190584

Intervention Type: DRUG

miotic for treatment of presbyopia

Interventions

AGN-190584

miotic for treatment of presbyopia

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

AbbVie

INDUSTRY

Sponsor Role: collaborator

Gordon Schanzlin New Vision

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

Gordon Schanzlin New Vision

Identifier Type: -

Identifier Source: org_study_id