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An Evaluation of the Efficacy and Safety of CSF-1 in the Temporary Correction of Presbyopia (NEAR-1) (NEAR-1)

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ClinicalTrials.gov Identifier: NCT04599933
Recruitment Status : Recruiting
First Posted : October 23, 2020
Last Update Posted : August 9, 2021
Sponsor:
Information provided by (Responsible Party):
Orasis Pharmaceuticals Ltd.

Tracking Information
First Submitted Date  ICMJE October 19, 2020
First Posted Date  ICMJE October 23, 2020
Last Update Posted Date August 9, 2021
Actual Study Start Date  ICMJE October 19, 2020
Estimated Primary Completion Date December 7, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 23, 2020)
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. [ Time Frame: Day 8 ]
Original Primary Outcome Measures  ICMJE
 (submitted: October 22, 2020)
Percentage of subjects with a ≥ 3-line gain in BDCVA at 40 cm and no loss in BDCVA ≥ 5 letters at 4m. [ Time Frame: Day 8 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 23, 2020)
Percentage of subjects with a ≥ 3-line gain in BDCVA at 40cm and no loss in BDCVA ≥ 5 letters at 4m. [ Time Frame: Day 1/Day 8/Day 15 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: October 22, 2020)
Percentage of subjects with a ≥ 3-line gain in BDCVA at 40 cm and no loss in BDCVA ≥ 5 letters. [ Time Frame: Day 1/Day 8/Day 15 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE An Evaluation of the Efficacy and Safety of CSF-1 in the Temporary Correction of Presbyopia (NEAR-1)
Official Title  ICMJE 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)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Presbyopia
Intervention  ICMJE
  • Drug: CSF-1
    One drop bilaterally twice daily for approximately 2 weeks.
  • Drug: Vehicle
    One drop bilaterally twice daily for approximately 2 weeks.
Study Arms  ICMJE
  • Experimental: CSF-1
    One drop bilaterally twice daily for approximately 2 weeks.
    Intervention: Drug: CSF-1
  • Placebo Comparator: Vehicle
    One drop bilaterally twice daily for approximately 2 weeks.
    Intervention: Drug: Vehicle
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 22, 2020)
300
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 14, 2021
Estimated Primary Completion Date December 7, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subjects must have presbyopia.

Exclusion Criteria:

Subjects must not:

  • Have any contraindications to the study medications or diagnoses that would confound the study.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 45 Years to 64 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Amy Baggeroer 978-409-5951 abaggeroer@oraclinical.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04599933
Other Study ID Numbers  ICMJE 20-150-0002
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Orasis Pharmaceuticals Ltd.
Study Sponsor  ICMJE Orasis Pharmaceuticals Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Orasis Pharmaceuticals Ltd.
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP