Status:
TERMINATED
A Dose-ranging Study to Evaluate the Safety and Efficacy of UNR844 in Subjects With Presbyopia.
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Presbyopia
Eligibility:
All Genders
45-55 years
Phase:
PHASE2
Brief 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 a...
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 :
June 30 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 14 2022
Estimated Enrollment :
234 Patients enrolled
Trial Details
Trial ID
NCT04806503
Start Date
June 30 2021
End Date
October 14 2022
Last Update
June 20 2024
Active Locations (20)
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1
Novartis Investigative Site
Laguna Hills, California, United States, 92653
2
Novartis Investigative Site
Newport Beach, California, United States, 92660
3
Novartis Investigative Site
Newport Beach, California, United States, 92663
4
Novartis Investigative Site
Largo, Florida, United States, 33773