A Dose-ranging Study to Evaluate the Safety and Efficacy of UNR844 in Subjects With Presbyopia.

Summary

Participation Requirements

Description

This is a multi-center, double-masked, placebo-controlled, randomized, parallel-group study. The total duration of the study is approximately 13 months. Approximately 225 presbyopic participants will be enrolled into the study. Presbyopic participants aged 45 to 55 years are the primary age group in...

This is a multi-center, double-masked, placebo-controlled, randomized, parallel-group study. The total duration of the study is approximately 13 months. Approximately 225 presbyopic participants will be enrolled into the study. Presbyopic participants aged 45 to 55 years are the primary age group in this study. Screening and Baseline: Participants will be screened for eligibility followed by a baseline visit after which they will be randomized to receive either UNR844 (low, medium 1, medium 2, and high) or Placebo, dosed one drop in each eye twice daily, for 3 months and then will undergo a 9 month treatment holiday period. Randomized subjects will attend the following study visits after baseline: at Week 2, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 7, Month 8, Month 9, Month 10, Month 11 and Month 12. The primary objective for the study is to characterize dose-response of UNR844 for change from baseline in binocular DCNVA at Month 3. There are 3 secondary objectives: Characterize dose response of UNR844 as measured by change from baseline in monocular DCNVA at Month 3 Assess the duration of effect using change in DCNVA after Month 3 with various dose concentrations of UNR844 Evaluate the efficacy of improving DCNVA in presbyopic participants, as measured by proportion of participants gaining at least 0.3 logMAR DCNVA at Month 3

Tracking Information