An Evaluation of the Efficacy and Safety of CSF-1 in the Temporary Correction of Presbyopia (NEAR-1)
NCT ID: NCT04599933
Last Updated: 2024-04-04
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
309 participants
INTERVENTIONAL
2020-10-18
2022-02-19
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
An Evaluation of the Efficacy and Safety of CSF-1 in the Temporary Correction of Presbyopia (NEAR-2)
NCT04599972
A Multi-Center, Double-Masked Evaluation of the Efficacy and Safety of CSF-1 in the Treatment of Presbyopia
NCT03885011
A Phase 1/2 Crossover Study to Assess EXP039 for Myopia or Hyperopia
NCT04883996
A Study to Evaluate the Safety and Efficacy of EV06 Ophthalmic Solution in Improving Vision in Subjects With Presbyopia
NCT02516306
Retinal Imaging in CNTF -Releasing Encapsulated Cell Implant Treated Patients for Early-stage Retinitis Pigmentosa
NCT01530659
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
CSF-1
One drop bilaterally twice daily for approximately 2 weeks.
Vehicle
One drop bilaterally twice daily for approximately 2 weeks.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
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
Meet the organizations funding or collaborating on the study and learn about their roles.
Orasis Pharmaceuticals Ltd.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Orasis Investigative Site
Sun City, Arizona, United States
Orasis Investigative Site
Glendale, California, United States
Orasis Investigative Site
Los Angeles, California, United States
Orasis Investigative Site
Fort Myers, Florida, United States
Orasis Investigative Site
Mt. Dora, Florida, United States
Orasis Investigative Site
Morrow, Georgia, United States
Orasis Investigative Site
Overland Park, Kansas, United States
Orasis Investigative Site
Louisville, Kentucky, United States
Orasis Investigative Site
Kansas City, Missouri, United States
Orasis Investigative Site
St Louis, Missouri, United States
Orasis Investigative Site
Henderson, Nevada, United States
Orasis Investigative Site
Elizabeth City, North Carolina, United States
Orasis Investigative Site
Cranberry Township, Pennsylvania, United States
Orasis Investigative Site
Wilkes-Barre, Pennsylvania, United States
Orasis Investigative Site
Rapid City, South Dakota, United States
Orasis Investigative Site
Memphis, Tennessee, United States
Orasis Investigative Site
El Paso, Texas, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
20-150-0002
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.