search
Back to results

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

Primary Purpose

Presbyopia

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
CSF-1
Vehicle
Sponsored by
Orasis Pharmaceuticals Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Presbyopia

Eligibility Criteria

45 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Orasis Investigative Site
  • Orasis Investigative Site
  • Orasis Investigative Site
  • Orasis Investigative Site
  • Orasis Investigative Site
  • Orasis Investigative Site
  • Orasis Investigative Site
  • Orasis Investigative Site
  • Orasis Investigative Site
  • Orasis Investigative Site
  • Orasis Investigative Site
  • Orasis Investigative Site
  • Orasis Investigative Site
  • Orasis Investigative Site
  • Orasis Investigative Site
  • Orasis Investigative Site
  • Orasis Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

CSF-1

Vehicle

Arm Description

One drop bilaterally twice daily for approximately 2 weeks.

One drop bilaterally twice daily for approximately 2 weeks.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Percentage of subjects with a ≥ 3-line gain in BDCVA at 40cm and no loss in BDCVA ≥ 5 letters at 4m.

Full Information

First Posted
October 19, 2020
Last Updated
January 8, 2023
Sponsor
Orasis Pharmaceuticals Ltd.
search

1. Study Identification

Unique Protocol Identification Number
NCT04599933
Brief Title
An Evaluation of the Efficacy and Safety of CSF-1 in the Temporary Correction of Presbyopia (NEAR-1)
Acronym
NEAR-1
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
October 19, 2020 (Actual)
Primary Completion Date
February 11, 2022 (Actual)
Study Completion Date
February 18, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Orasis Pharmaceuticals Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Presbyopia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
309 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CSF-1
Arm Type
Experimental
Arm Description
One drop bilaterally twice daily for approximately 2 weeks.
Arm Title
Vehicle
Arm Type
Placebo Comparator
Arm Description
One drop bilaterally twice daily for approximately 2 weeks.
Intervention Type
Drug
Intervention Name(s)
CSF-1
Other Intervention Name(s)
pilocarpine HCl 0.4%
Intervention Description
One drop bilaterally twice daily for approximately 2 weeks.
Intervention Type
Drug
Intervention Name(s)
Vehicle
Intervention Description
One drop bilaterally twice daily for approximately 2 weeks.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Orasis Investigative Site
City
Sun City
State/Province
Arizona
ZIP/Postal Code
85351
Country
United States
Facility Name
Orasis Investigative Site
City
Glendale
State/Province
California
ZIP/Postal Code
91204
Country
United States
Facility Name
Orasis Investigative Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90013
Country
United States
Facility Name
Orasis Investigative Site
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33901
Country
United States
Facility Name
Orasis Investigative Site
City
Mount Dora
State/Province
Florida
ZIP/Postal Code
32757
Country
United States
Facility Name
Orasis Investigative Site
City
Morrow
State/Province
Georgia
ZIP/Postal Code
30260
Country
United States
Facility Name
Orasis Investigative Site
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66210
Country
United States
Facility Name
Orasis Investigative Site
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40206
Country
United States
Facility Name
Orasis Investigative Site
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64133
Country
United States
Facility Name
Orasis Investigative Site
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63131
Country
United States
Facility Name
Orasis Investigative Site
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89052
Country
United States
Facility Name
Orasis Investigative Site
City
Elizabeth City
State/Province
North Carolina
ZIP/Postal Code
27909
Country
United States
Facility Name
Orasis Investigative Site
City
Cranberry Township
State/Province
Pennsylvania
ZIP/Postal Code
16066
Country
United States
Facility Name
Orasis Investigative Site
City
Wilkes-Barre
State/Province
Pennsylvania
ZIP/Postal Code
18702
Country
United States
Facility Name
Orasis Investigative Site
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57701
Country
United States
Facility Name
Orasis Investigative Site
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Orasis Investigative Site
City
El Paso
State/Province
Texas
ZIP/Postal Code
79902
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs