An Evaluation of the Efficacy and Safety of CSF-1 in the Temporary Correction of Presbyopia (NEAR-2) (NEAR-2)

A Multi-Center, Double-Masked, Vehicle-Controlled, Evaluation of the Efficacy and Safety of CSF-1 in the Temporary Correction of Presbyopia (the NEAR-2 Study: Near Eye-vision Acuity Restoration)

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.

Study Overview

• Status: Completed
• Conditions: Presbyopia
• Intervention / Treatment: Drug: CSF-1; Drug: Vehicle

• Study Type: Interventional
• Enrollment (Actual): 304
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Chandler, Arizona, United States, 85225
      • Orasis Investigative Site
    • Mesa, Arizona, United States, 85202
      • Orasis Investigative Site
    • Phoenix, Arizona, United States, 85032
      • Orasis Investigative Site
  • California
    • Garden Grove, California, United States, 92843
      • Orasis Investigative Site
    • Mission Hills, California, United States, 91345
      • Orasis Investigative Site
    • Newport Beach, California, United States, 92663
      • Orasis Investigative Site
    • Petaluma, California, United States, 94954
      • Orasis Investigative Site
  • Colorado
    • Littleton, Colorado, United States, 80120
      • Orasis Investigative Site
  • Connecticut
    • Danbury, Connecticut, United States, 06810
      • Orasis Investigative Site
  • Florida
    • Delray Beach, Florida, United States, 33484
      • Orasis Investigative Site
  • Illinois
    • Rock Island, Illinois, United States, 61201
      • Orasis Investigative Site
  • New York
    • Rochester, New York, United States, 14618
      • Orasis Investigative Site
  • Pennsylvania
    • Kingston, Pennsylvania, United States, 18704
      • Orasis Investigative Site
  • Texas
    • Cedar Park, Texas, United States, 78613
      • Orasis Investigative Site
    • San Antonio, Texas, United States, 78229
      • Orasis Investigative Site
  • Utah
    • Clinton, Utah, United States, 84015
      • Orasis Investigative Site
    • Draper, Utah, United States, 84020
      • Orasis Investigative Site
  • Virginia
    • Lynchburg, Virginia, United States, 24502
      • Orasis Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 64 years (Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CSF-1; One drop bilaterally twice daily for approximately 2 weeks.	Drug: CSF-1; One drop bilaterally twice daily for approximately 2 weeks.; Other Names: pilocarpine HCl 0.4%
Placebo Comparator: Vehicle; One drop bilaterally twice daily for approximately 2 weeks.	Drug: Vehicle; One drop bilaterally twice daily for approximately 2 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Subjects With a ≥ 3-line Gain in BDCVA at 40cm and no Loss in BDCVA ≥ 5 Letters at 4m.	The key secondary endpoints were measured on Day 8 at different time points and were the percentage of subjects with a ≥ 3-line (15-letter) gain, from baseline, in BDCVA at 40 cm (Precision Vision Chart) and no loss in BDCVA ≥ 5 letters (ETDRS chart at 4 m) in the study eye.	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	The key secondary endpoints were measured on Day 8 at different time points and were the percentage of subjects with a ≥ 3-line (15-letter) gain, from baseline, in BDCVA at 40 cm (Precision Vision Chart) and no loss in BDCVA ≥ 5 letters (ETDRS chart at 4 m) in the study eye.	Baseline (Day 1) to Day 8 (1 hour post Dose 2; Dose 2 occurred 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	The key secondary endpoints were measured on Day 8 at different time points and were the percentage of subjects with a ≥ 3-line (15-letter) gain, from baseline, in BDCVA at 40 cm (Precision Vision Chart) and no loss in BDCVA ≥ 5 letters (ETDRS chart at 4 m) in the study eye.	Baseline (Day 1) to Day 8 (2 hours post Dose 2; Dose 2 occurred 2 hours following Dose 1)

Collaborators and Investigators

• Sponsor: Orasis Pharmaceuticals Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): October 26, 2020
• Primary Completion (Actual): January 21, 2022
• Study Completion (Actual): January 28, 2022

Study Registration Dates

• First Submitted: October 19, 2020
• First Submitted That Met QC Criteria: October 22, 2020
• First Posted (Actual): October 23, 2020

Study Record Updates

• Last Update Posted (Actual): April 4, 2024
• Last Update Submitted That Met QC Criteria: April 2, 2024
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Presbyopia; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Cholinergic Agonists; Miotics; Muscarinic Agonists; Pilocarpine
• Other Study ID Numbers: 20-150-0003

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No