NCT03809611

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

A 3-month, Randomized, Placebo-controlled, Double-masked, Multi-center Study to Evaluate the Safety and Efficacy of Topical Ocular UNR844-Cl in Subjects With Presbyopia

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 125 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 45 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This was a multi-center, double-masked, placebo-controlled, randomized, parallel-group study. The total duration of the study was approximately 3 months. Approximately 120 presbyopic subjects were to be enrolled into the study. Presbyopic subjects aged 45 to 55 years were the primary age group in this study. Screening and Baseline: Subjects were screened for eligibility followed by a baseline visit after which they were randomized to receive either UNR844-Cl (1.5%, equivalent to 1.3% freebase) or Placebo, dosed one drop in each eye twice daily, for 3 months. Randomized subjects attended the following study visits after baseline: at Week 2, Month 1, Month 2 and Month 3. The primary objective of this study was to assess the efficacy of UNR844-Cl on binocular distance corrected near visual acuity (DCNVA) in presbyopic subjects aged 45 to 55 years with the primary endpoint being the change from baseline in binocular DCNVA in subjects aged 45 to 55 years at Month 3 after UNR844-Cl or Placebo treatment. There were two secondary endpoints: 1. To assess the efficacy of UNR844-Cl on achieving 75 or more Early Treatment Diabetic Retinopathy Study (ETDRS) letters in binocular DCNVA in presbyopic subjects aged 45 to 55 years with endpoint being the proportion of subjects aged 45 to 55 years achieving 75 or more ETDRS letters in binocular DCNVA at Month 3 after UNR844-Cl or Placebo treatment. 2. To assess the safety of UNR844-Cl in presbyopic subjects by the frequency of treatment emergent adverse events (AEs) and treatment emergent serious adverse events (SAEs) in all subjects after UNR844-Cl or Placebo treatment.

Conditions

• Presbyopia

Interventions

Type	Name	Description
DRUG	UNR844-Cl	1.5% Ophthalmic solution for topical ocular administration
DRUG	Placebo	placebo

Timeline

• Start date: 2019-04-26
• Primary completion: 2019-12-16
• Completion: 2019-12-16
• First posted: 2019-01-18
• Last updated: 2022-05-11
• Results posted: 2020-11-27

Locations

14 sites across 1 country: United States

Regulatory

• FDA-regulated drug study