Phase 2 N=124 Randomized Double-blind Treatment

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

Presbyopia

Bottom Line

View on ClinicalTrials.gov: NCT03809611 ↗

Enrolled (actual)

124

Serious AEs

0.0%

Results posted

Nov 2020

Primary outcome: Primary: Change in Binocular Distance-corrected Near Visual Acuity (DCNVA) From Baseline — 6.1; 4.5 number of letters read correctly — p=0.1832

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: UNR844-Cl (Drug); Placebo (Drug)
Age: Adult, Older Adult · 45+ yrs
Sex: All
Sponsor: Novartis Pharmaceuticals
Primary completion: Dec 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Binocular Distance-corrected Near Visual Acuity (DCNVA) From Baseline	6.1; 4.5	0.1832
SECONDARY Number and Percentage of Subjects Aged 45 to 55 Years Achieving 75 or More Early Treatment Diabetic Retinopathy Study (ETDRS) Letters in Binocular DCNVA at Month 3	10; 6	0.2830
SECONDARY Number of Subjects With Adverse Events, Ocular Adverse Events, Deaths, Other Serious Adverse Events, or Adverse Events Leading to Study Drug Discontinuation	14; 5; 4; 4; 11; 2	—

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.

Eligibility Criteria

Inclusion Criteria

Written informed consent must be obtained before any assessment is performed
Impaired near vision in each eye and when using both eyes, without any near correction
Need a certain level of near correction

Exclusion Criteria

Impaired distance vision in either eye, with distance correction (if any)
Severe short- or long-sightedness
Any significant medical or clinical conditions affecting vision, the eyes or general health

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03809611). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.