A Safety, Efficacy and Pharmacokinetic Study of AGN-199201 and AGN-190584 in Patients With Presbyopia

Summary

This is a safety, efficacy and pharmacokinetics study of the fixed combination of AGN-199201 and AGN-190584 in participants with presbyopia (inability to focus on items close-up).

Timeline

Start

2016-05-26

Primary completion

2017-10-31

Completion

2017-10-31

Outcome

Met primary endpoint

registry analysis (superiority test); Cohort 3: AGN-199201 Medium Dose and AGN-190584 Medium Dose; p = 0.0009; LS Mean Diff 4.77 (95% CI 1.98 to 7.56); ANCOVA NCT02780115 ↗

Publications

• Shirneshan E, Coon CD, Johnson N, Stokes J, Wells T, Lundy JJ, Andrae DA, Evans CJ, Campbell J. Development of the Near Vision Presbyopia Task-based Questionnaire for use in evaluating the impact of presbyopia. J Patient Rep Outcomes. 2021 Dec 2;5(1):125. doi: 10.1186/s41687-021-00378-y.
• Johnson N, Shirneshan E, Coon CD, Stokes J, Wells T, Lundy JJ, Andrae DA, Evans CJ, Campbell J. Development of the Presbyopia Impact and Coping Questionnaire. Ophthalmol Ther. 2021 Dec;10(4):1057-1075. doi: 10.1007/s40123-021-00391-w. Epub 2021 Oct 13.

Drugs

Indications