Phase 2
Completed N=124
A Study of Safety and Efficacy of UNR844 Chloride (UNR844-Cl) Eye Drops in Subjects With Presbyopia.
Source: ClinicalTrials.gov NCT03809611 ↗Enrolled (actual)
124
Serious AEs
0.0%
Results posted
Nov 2020
Primary outcomePrimary: Change in Binocular Distance-corrected Near Visual Acuity (DCNVA) From Baseline — 6.1; 4.5 number of letters read correctly — p=0.1832
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.
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 | — |
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
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. Informational only — not medical advice.