A Dose-ranging Study to Evaluate the Safety and Efficacy of UNR844 in Subjects With Presbyopia.
NCT ID: NCT04806503
Last Updated: 2024-06-20
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
234 participants
INTERVENTIONAL
2021-06-30
2022-10-14
Brief Summary
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Detailed Description
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* A 1 week run-in period
* A 3-month treatment course with UNR844 and/or Placebo
* A 9-month treatment holiday period Participants were randomized equally to one of five treatment arms: UNR844 5 mg/mL,UNR844 13.3 mg/mL, UNR844 23 mg/mL, UNR844 30 mg/mL, or Placebo eye drops twice-a-day for three months.
Participants underwent a 1 week run-in period where they were assessed for entry criteria during the Screening visit. During the run-in period, participants self-administered 1 drop of artificial tears twice-a-day (1 drop in the morning and 1 drop in the evening) in each eye at home. This run-in period was designed to help minimize any potential variability in distance corrected near visual acuity (DCNVA) caused due to initial ocular surface issues and help to establish an accurate baseline prior to randomization. The run-in period was to help exclude participants with a change in DCNVA of 0.10 logMAR difference between Screening and Baseline.
This study was conducted to determine the optimum dose of UNR844 treatment and the duration of effect of UNR844 treatment for further development.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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UNR844 5 mg/mL
UNR844 5 mg/mL ophthalmic solution; one drop twice-a-day for three months
UNR844
Ophthalmic solution for topical ocular administration
UNR844 13.3 mg/mL
UNR844 13.3 mg/mL 1 ophthalmic solution; one drop twice-a-day for three months
UNR844
Ophthalmic solution for topical ocular administration
UNR844 23 mg/mL
UNR844 23 mg/mL ophthalmic solution; one drop twice-a-day for three months
UNR844
Ophthalmic solution for topical ocular administration
UNR844 30 mg/mL
UNR844 30 mg/mL ophthalmic solution; one drop twice-a-day for three months
UNR844
Ophthalmic solution for topical ocular administration
Placebo Ophthalmic Solution
placebo ophthalmic solution; one drop twice-a-day for three months
Placebo
Placebo
Interventions
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UNR844
Ophthalmic solution for topical ocular administration
Placebo
Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Impaired near vision in each eye and when using both eyes, without any near correction
* Need a certain level of near correction
Exclusion Criteria
* Severe short- or long-sightedness
* Any significant medical or clinical conditions affecting vision, the eyes or general health
45 Years
55 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Novartis Investigative Site
Laguna Hills, California, United States
Novartis Investigative Site
Newport Beach, California, United States
Novartis Investigative Site
Newport Beach, California, United States
Novartis Investigative Site
Largo, Florida, United States
Novartis Investigative Site
Lake Villa, Illinois, United States
Novartis Investigative Site
Pittsburg, Kansas, United States
Novartis Investigative Site
Washington, Missouri, United States
Novartis Investigative Site
Kingston, Pennsylvania, United States
Novartis Investigative Site
Sioux Falls, South Dakota, United States
Novartis Investigative Site
Memphis, Tennessee, United States
Novartis Investigative Site
Smyrna, Tennessee, United States
Novartis Investigative Site
San Antonio, Texas, United States
Novartis Investigative Site
Sydney, New South Wales, Australia
Novartis Investigative Site
East Melbourne, Victoria, Australia
Novartis Investigative Site
Vancouver, British Columbia, Canada
Novartis Investigative Site
Kitchener, Ontario, Canada
Novartis Investigative Site
Waterloo, Ontario, Canada
Novartis Investigative Site
Québec, Quebec, Canada
Novartis Investigative Site
Suita, Osaka, Japan
Novartis Investigative Site
Shinjuku Ku, Tokyo, Japan
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Patient Lay Trial Summary
Other Identifiers
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CUNR844A2202
Identifier Type: -
Identifier Source: org_study_id
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