Study Stopped
The study was discontinued by the Sponsor because it did not achieve the primary objective.
A Dose-ranging Study to Evaluate the Safety and Efficacy of UNR844 in Subjects With Presbyopia.
READER
A Randomized, Placebo-controlled, Double-masked, Multi-center, Dose-ranging Study to Evaluate the Safety, and Efficacy of UNR844 in Subjects With Presbyopia
1 other identifier
interventional
234
4 countries
20
Brief Summary
Study of safety and efficacy of UNR844 in subjects with presbyopia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jun 2021
Shorter than P25 for phase_2
20 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
March 16, 2021
CompletedFirst Posted
Study publicly available on registry
March 19, 2021
CompletedStudy Start
First participant enrolled
June 30, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 27, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
October 14, 2022
CompletedResults Posted
Study results publicly available
August 30, 2023
CompletedJune 20, 2024
June 1, 2024
1.1 years
March 16, 2021
July 14, 2023
June 17, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Characterize Dose-response of UNR844 for Change From Baseline in Binocular Distance-corrected Near Visual Acuity (DCNVA) at Month 3
Characterize dose response of UNR844 as measured by change from baseline at Month 3 in binocular DCNVA (without near correction) in Logarithm of Minimum Angle of Resolution (logMAR), at 40cm. A low logMAR score represents good vision while a high logMAR score represents bad vision.
Baseline, Month 3
Secondary Outcomes (5)
Characterize Dose Response of UNR844 as Measured by Change From Baseline in Monocular (Worse-seeing Eye) Distance-corrected Near Visual Acuity (DCNVA) at Month 3
Baseline, Month 3
Characterize Dose Response of UNR844 as Measured by Change From Baseline in Monocular (Better-seeing Eye) Distance-corrected Near Visual Acuity (DCNVA) at Month 3
Baseline, Month 3
Percentage of Participants Gaining at Least 0.30 logMAR in Binocular Distance-corrected Near Visual Acuity (DCNVA) (Without Near Correction) From Baseline at Month 3
Baseline, Month 3
Percentage of Participants Gaining at Least 0.30 logMAR in Monocular (Worse-seeing Eye) Distance-corrected Near Visual Acuity (DCNVA) (Without Near Correction) From Baseline at Month 3
Baseline, Month 3
Percentage of Participants Gaining at Least 0.30 logMAR in Monocular (Better-seeing Eye) Distance-corrected Near Visual Acuity (DCNVA) (Without Near Correction) From Baseline at Month 3
Baseline, Month 3
Study Arms (5)
UNR844 5 mg/mL
EXPERIMENTALUNR844 5 mg/mL ophthalmic solution; one drop twice-a-day for three months
UNR844 13.3 mg/mL
EXPERIMENTALUNR844 13.3 mg/mL 1 ophthalmic solution; one drop twice-a-day for three months
UNR844 23 mg/mL
EXPERIMENTALUNR844 23 mg/mL ophthalmic solution; one drop twice-a-day for three months
UNR844 30 mg/mL
EXPERIMENTALUNR844 30 mg/mL ophthalmic solution; one drop twice-a-day for three months
Placebo Ophthalmic Solution
PLACEBO COMPARATORplacebo ophthalmic solution; one drop twice-a-day for three months
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 (20)
Novartis Investigative Site
Laguna Hills, California, 92653, United States
Novartis Investigative Site
Newport Beach, California, 92660, United States
Novartis Investigative Site
Newport Beach, California, 92663, United States
Novartis Investigative Site
Largo, Florida, 33773, United States
Novartis Investigative Site
Lake Villa, Illinois, 60046, United States
Novartis Investigative Site
Pittsburg, Kansas, 66762, United States
Novartis Investigative Site
Washington, Missouri, 63090, United States
Novartis Investigative Site
Kingston, Pennsylvania, 18704, United States
Novartis Investigative Site
Sioux Falls, South Dakota, 57108, United States
Novartis Investigative Site
Memphis, Tennessee, 38119, United States
Novartis Investigative Site
Smyrna, Tennessee, 37167, United States
Novartis Investigative Site
San Antonio, Texas, 78229, United States
Novartis Investigative Site
Sydney, New South Wales, 2052, Australia
Novartis Investigative Site
East Melbourne, Victoria, 3002, Australia
Novartis Investigative Site
Vancouver, British Columbia, V6H 1H6, Canada
Novartis Investigative Site
Kitchener, Ontario, N2A 0K5, Canada
Novartis Investigative Site
Waterloo, Ontario, N2L3G1, Canada
Novartis Investigative Site
Québec, Quebec, G1S 4L8, Canada
Novartis Investigative Site
Suita, Osaka, 565-0853, Japan
Novartis Investigative Site
Shinjuku Ku, Tokyo, 160-0008, Japan
Related Links
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
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 16, 2021
First Posted
March 19, 2021
Study Start
June 30, 2021
Primary Completion
July 27, 2022
Study Completion
October 14, 2022
Last Updated
June 20, 2024
Results First Posted
August 30, 2023
Record last verified: 2024-06
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. This trial data availability is according to the criteria and process described on https://www.clinicalstudydatarequest.com/.