Status:
COMPLETED
A Study of Safety and Efficacy of UNR844 Chloride (UNR844-Cl) Eye Drops in Subjects With Presbyopia.
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Presbyopia
Eligibility:
All Genders
45-65 years
Phase:
PHASE2
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 26 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 16 2019
Estimated Enrollment :
125 Patients enrolled
Trial Details
Trial ID
NCT03809611
Start Date
April 26 2019
End Date
December 16 2019
Last Update
May 11 2022
Active Locations (14)
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1
Novartis Investigative Site
Mission Hills, California, United States, 91345
2
Novartis Investigative Site
Newport Beach, California, United States, 92663
3
Novartis Investigative Site
Largo, Florida, United States, 33773
4
Novartis Investigative Site
Mt. Dora, Florida, United States, 32757