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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Presbyopia

Intervention / Treatment
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* Drug: AGN-190584


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: single center open label, single arm study with no control and no randomization<br>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<br>* miotic for treatment of presbyopia<br>|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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presbyopia