An Evaluation of the Efficacy and Safety of CSF-1 in the Temporary Correction of Presbyopia (NEAR-2)
NCT ID: NCT04599972
Last Updated: 2024-04-04
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
304 participants
INTERVENTIONAL
2020-10-26
2022-01-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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CSF-1
One drop bilaterally twice daily for approximately 2 weeks.
CSF-1
One drop bilaterally twice daily for approximately 2 weeks.
Vehicle
One drop bilaterally twice daily for approximately 2 weeks.
Vehicle
One drop bilaterally twice daily for approximately 2 weeks.
Interventions
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CSF-1
One drop bilaterally twice daily for approximately 2 weeks.
Vehicle
One drop bilaterally twice daily for approximately 2 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Have any contraindications to the study medications or diagnoses that would confound the study.
45 Years
64 Years
ALL
No
Sponsors
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Orasis Pharmaceuticals Ltd.
INDUSTRY
Responsible Party
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Locations
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Orasis Investigative Site
Chandler, Arizona, United States
Orasis Investigative Site
Mesa, Arizona, United States
Orasis Investigative Site
Phoenix, Arizona, United States
Orasis Investigative Site
Garden Grove, California, United States
Orasis Investigative Site
Mission Hills, California, United States
Orasis Investigative Site
Newport Beach, California, United States
Orasis Investigative Site
Petaluma, California, United States
Orasis Investigative Site
Littleton, Colorado, United States
Orasis Investigative Site
Danbury, Connecticut, United States
Orasis Investigative Site
Delray Beach, Florida, United States
Orasis Investigative Site
Rock Island, Illinois, United States
Orasis Investigative Site
Rochester, New York, United States
Orasis Investigative Site
Kingston, Pennsylvania, United States
Orasis Investigative Site
Cedar Park, Texas, United States
Orasis Investigative Site
San Antonio, Texas, United States
Orasis Investigative Site
Clinton, Utah, United States
Orasis Investigative Site
Draper, Utah, United States
Orasis Investigative Site
Lynchburg, Virginia, United States
Countries
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References
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Holland E, Karpecki P, Fingeret M, Schaeffer J, Gupta P, Fram N, Smits G, Ignacio T, Lindstrom R. Efficacy and Safety of CSF-1 (0.4% Pilocarpine Hydrochloride) in Presbyopia: Pooled Results of the NEAR Phase 3 Randomized, Clinical Trials. Clin Ther. 2024 Feb;46(2):104-113. doi: 10.1016/j.clinthera.2023.12.005. Epub 2024 Jan 11.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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20-150-0003
Identifier Type: -
Identifier Source: org_study_id
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