Study Stopped
Lack of interest
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
1 other identifier
interventional
N/A
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Dec 2022
Shorter than P25 for phase_4
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 14, 2022
CompletedFirst Posted
Study publicly available on registry
November 22, 2022
CompletedStudy Start
First participant enrolled
December 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2023
CompletedApril 9, 2024
November 1, 2022
6 months
November 14, 2022
April 5, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
secondary endpoint will be changes in intermediate letters read from baseline
30 days
Study Arms (1)
single center open label, single arm study with no control and no randomization
EXPERIMENTALInvestigators 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
Interventions
miotic for treatment of presbyopia
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gordon Schanzlin New Visionlead
- AbbViecollaborator
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 14, 2022
First Posted
November 22, 2022
Study Start
December 1, 2022
Primary Completion
May 30, 2023
Study Completion
June 30, 2023
Last Updated
April 9, 2024
Record last verified: 2022-11
Data Sharing
- IPD Sharing
- Will not share