An Evaluation of the Efficacy and Safety of CSF-1 in the Temporary Correction of Presbyopia (NEAR-1)
NEAR-1
A Multi-Center, Double-Masked, Vehicle-Controlled, Evaluation of the Efficacy and Safety of CSF-1 in the Temporary Correction of Presbyopia (the NEAR-1 Study: Near Eye-vision Acuity Restoration)
1 other identifier
interventional
309
1 country
17
Brief Summary
This is a 4-visit, multi-center, randomized, double-masked, vehicle-controlled study evaluating the safety and efficacy of CSF-1 in the temporary correction of presbyopia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Oct 2020
Shorter than P25 for phase_3
17 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
Study Start
First participant enrolled
October 18, 2020
CompletedFirst Submitted
Initial submission to the registry
October 19, 2020
CompletedFirst Posted
Study publicly available on registry
October 23, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 11, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
February 19, 2022
CompletedResults Posted
Study results publicly available
November 28, 2023
CompletedApril 4, 2024
October 1, 2020
1.3 years
October 19, 2020
November 12, 2023
April 2, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Subjects With a ≥ 3-line Gain in BDCVA (Best Distance-Corrected Visual Acuity) at 40cm and no Loss in BDCVA ≥ 5 Letters at 4m on Day 8, 1 Hour Post-Dose 1.
The primary end-point was measured on Day 8, 1 hour post first CSF-1 dose, as the number of participants who are responders to the treatment. A responder was defined as as subject with a ≥ 3-line gain in BDCVA (Best Distance-Corrected Visual Acuity) at 40cm and no loss in BDCVA ≥ 5 letters at 4m.
Baseline (Day 1) to Day 8 (1 hour post-Dose 1)
Secondary Outcomes (3)
Percentage of Subjects With a ≥ 3-line Gain in BDCVA at 40cm and no Loss in BDCVA ≥ 5 Letters at 4m on Day 8 at 2 Hours Post-Dose 1
Baseline (Day 1) to Day 8 (2 hours post-Dose 1)
Percentage of Subjects With a ≥ 3-line Gain in BDCVA at 40cm and no Loss in BDCVA ≥ 5 Letters at 4m on Day 8 at 1 Hour Post-Dose 2
Baseline (Day 1) to Day 8 (1 hour post-Dose 2; Dose 2 occurs 2 hours following Dose 1)
Percentage of Subjects With a ≥ 3-line Gain in BDCVA at 40cm and no Loss in BDCVA ≥ 5 Letters at 4m on Day 8 at 2 Hours Post-dose 2
Baseline (Day 1) to Day 8 (2 hours post-Dose 2; Dose 2 occurs 2 hours following Dose 1)
Study Arms (2)
CSF-1
EXPERIMENTALOne drop bilaterally twice daily for approximately 2 weeks.
Vehicle
PLACEBO COMPARATOROne drop bilaterally twice daily for approximately 2 weeks.
Interventions
Eligibility Criteria
You may qualify if:
- Subjects must have presbyopia.
You may not qualify if:
- Subjects must not:
- Have any contraindications to the study medications or diagnoses that would confound the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
Orasis Investigative Site
Sun City, Arizona, 85351, United States
Orasis Investigative Site
Glendale, California, 91204, United States
Orasis Investigative Site
Los Angeles, California, 90013, United States
Orasis Investigative Site
Fort Myers, Florida, 33901, United States
Orasis Investigative Site
Mt. Dora, Florida, 32757, United States
Orasis Investigative Site
Morrow, Georgia, 30260, United States
Orasis Investigative Site
Overland Park, Kansas, 66210, United States
Orasis Investigative Site
Louisville, Kentucky, 40206, United States
Orasis Investigative Site
Kansas City, Missouri, 64133, United States
Orasis Investigative Site
St Louis, Missouri, 63131, United States
Orasis Investigative Site
Henderson, Nevada, 89052, United States
Orasis Investigative Site
Elizabeth City, North Carolina, 27909, United States
Orasis Investigative Site
Cranberry Township, Pennsylvania, 16066, United States
Orasis Investigative Site
Wilkes-Barre, Pennsylvania, 18702, United States
Orasis Investigative Site
Rapid City, South Dakota, 57701, United States
Orasis Investigative Site
Memphis, Tennessee, 38119, United States
Orasis Investigative Site
El Paso, Texas, 79902, United States
Related Publications (1)
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.
PMID: 38216351DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Head of Regulatory Affairs
- Organization
- Orasis Pharmaceuticals, Ltd.
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 19, 2020
First Posted
October 23, 2020
Study Start
October 18, 2020
Primary Completion
February 11, 2022
Study Completion
February 19, 2022
Last Updated
April 4, 2024
Results First Posted
November 28, 2023
Record last verified: 2020-10