Clinical trial

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

Name

Gordon Schanzlin New Vision

Description

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.

Trial arms

Trial start

2022-12-01

Estimated PCD

2023-05-30

Trial end

2023-06-30

Status

Withdrawn

Phase

Early phase I

Treatment

AGN-190584

miotic for treatment of presbyopia

Arms:

single center open label, single arm study with no control and no randomization

Primary endpoint

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

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 0, 'type': 'ACTUAL'}}

Updated at

2024-04-09

1 organization

1 product

1 indication

Organization

Gordon Schanzlin New Vision

Product

AGN-190584

Indication

Presbyopia