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
1 other identifier
interventional
125
1 country
14
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Apr 2019
Shorter than P25 for phase_2
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 17, 2019
CompletedFirst Posted
Study publicly available on registry
January 18, 2019
CompletedStudy Start
First participant enrolled
April 26, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 16, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 16, 2019
CompletedResults Posted
Study results publicly available
November 27, 2020
CompletedMay 11, 2022
April 1, 2022
8 months
January 17, 2019
September 28, 2020
April 18, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Binocular Distance-corrected Near Visual Acuity (DCNVA) From Baseline
Change from baseline in binocular DCNVA in subjects aged 45 to 55 years at Month 3 after UNR844-Cl or placebo treatment. Low contrast (10% contrast) DCNVA at 40 cm is measured binocularly using an electronic visual acuity testing system. This assessment was performed with subjects corrected for any distance refractive errors. The system provided distance-corrected low contrast near visual acuity in an Early Treatment Diabetic Retinopathy Study (ETDRS) letter numerical score. High monocular DCNVA ETDRS letter scores represent good vision; Low monocular DCNVA ETDRS letter scores represent poor vision.
Baseline and at Month 3
Secondary Outcomes (2)
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
month 3
Number of Subjects With Adverse Events, Ocular Adverse Events, Deaths, Other Serious Adverse Events, or Adverse Events Leading to Study Drug Discontinuation
4 months
Study Arms (2)
UNR844-Cl Ophthalmic Solution
EXPERIMENTAL1.5% UNR844-Cl ophthalmic solution for twice-daily dosing
Placebo Ophthalmic Solution
PLACEBO COMPARATORplacebo ophthalmic solution for twice-daily dosing
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (14)
Novartis Investigative Site
Mission Hills, California, 91345, United States
Novartis Investigative Site
Newport Beach, California, 92663, United States
Novartis Investigative Site
Largo, Florida, 33773, United States
Novartis Investigative Site
Mt. Dora, Florida, 32757, United States
Novartis Investigative Site
Washington, Missouri, 63090, United States
Novartis Investigative Site
Allenwood, Pennsylvania, 17810, United States
Novartis Investigative Site
Cranberry Township, Pennsylvania, 16066, United States
Novartis Investigative Site
Kingston, Pennsylvania, 18704, United States
Novartis Investigative Site
Memphis, Tennessee, 38119, United States
Novartis Investigative Site
Nashville, Tennessee, 37205-2013, United States
Novartis Investigative Site
Nashville, Tennessee, 37205, United States
Novartis Investigative Site
Cedar Park, Texas, 78613, United States
Novartis Investigative Site
Houston, Texas, 77204, United States
Novartis Investigative Site
Norfolk, Virginia, 23502, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Novartis Pharmaceuticals
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- double-mask(Investigator, patient)
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 17, 2019
First Posted
January 18, 2019
Study Start
April 26, 2019
Primary Completion
December 16, 2019
Study Completion
December 16, 2019
Last Updated
May 11, 2022
Results First Posted
November 27, 2020
Record last verified: 2022-04
Data Sharing
- IPD Sharing
- Will share
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.