NCT04806503

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

A Randomized, Placebo-controlled, Double-masked, Multi-center, Dose-ranging Study to Evaluate the Safety, and Efficacy of UNR844 in Subjects With Presbyopia

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 234 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 45 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

Study of safety and efficacy of UNR844 in subjects with presbyopia.

Detailed description

This was a randomized, placebo-controlled, double-masked,multi-arm, parallel-group, multi-center 13-month study which consisted of: * A 1 week run-in period * A 3-month treatment course with UNR844 and/or Placebo * A 9-month treatment holiday period Participants were randomized equally to one of five treatment arms: UNR844 5 mg/mL,UNR844 13.3 mg/mL, UNR844 23 mg/mL, UNR844 30 mg/mL, or Placebo eye drops twice-a-day for three months. Participants underwent a 1 week run-in period where they were assessed for entry criteria during the Screening visit. During the run-in period, participants self-administered 1 drop of artificial tears twice-a-day (1 drop in the morning and 1 drop in the evening) in each eye at home. This run-in period was designed to help minimize any potential variability in distance corrected near visual acuity (DCNVA) caused due to initial ocular surface issues and help to establish an accurate baseline prior to randomization. The run-in period was to help exclude participants with a change in DCNVA of 0.10 logMAR difference between Screening and Baseline. This study was conducted to determine the optimum dose of UNR844 treatment and the duration of effect of UNR844 treatment for further development.

Conditions

• Presbyopia

Interventions

Type	Name	Description
DRUG	UNR844	Ophthalmic solution for topical ocular administration
DRUG	Placebo	Placebo

Timeline

• Start date: 2021-06-30
• Primary completion: 2022-07-27
• Completion: 2022-10-14
• First posted: 2021-03-19
• Last updated: 2024-06-20
• Results posted: 2023-08-30

Locations

20 sites across 4 countries: United States, Australia, Canada, Japan

Regulatory

• FDA-regulated drug study