drugset / Trial / NCT03809611

A Study of Safety and Efficacy of UNR844 Chloride (UNR844-Cl) Eye Drops in Subjects With Presbyopia.

NCT03809611 ↗

Phase 2 Completed 125 enrolled Novartis Pharmaceuticals
RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of this study was to assess the effect of topical UNR844-Cl (lipoic acid choline ester chloride) ophthalmic solution on near visual function in presbyopic subjects.

Timeline

Start
2019-04-26
Primary completion
2019-12-16
Completion
2019-12-16

Outcome

Missed primary endpoint

registry analysis (superiority test); UNR844-Cl vs Placebo Ophthalmic Solution; p = 0.1832; Mean Difference (Net) 1.6 (90% CI -1.34 to 4.56) NCT03809611 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject UNR844-Cl Unknown 1.5 % Topical

Indications