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An Evaluation of the Safety of CSF-1 in Presbyopic Subjects

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

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

Inclusion Criteria:

  • Subjects must have presbyopia

Exclusion Criteria:

  • Have any contraindications to the study medications or diagnoses that would confound the study data

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

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 6 weeks

One drop bilaterally twice daily for approximately 6 weeks

Outcomes

Primary Outcome Measures

Number of participants with treatment emergent adverse events.

Secondary Outcome Measures

Full Information

First Posted
May 10, 2022
Last Updated
December 13, 2022
Sponsor
Orasis Pharmaceuticals Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05393895
Brief Title
An Evaluation of the Safety of CSF-1 in Presbyopic Subjects
Official Title
A Multi-Center, Double-Masked, Vehicle-Controlled, Evaluation of the Safety of CSF-1 in Presbyopic Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
April 22, 2022 (Actual)
Primary Completion Date
December 1, 2022 (Actual)
Study Completion Date
December 1, 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 multi-center, double-masked, vehicle-controlled study. The purpose of the study is to evaluate the safety of CSF-1 compared with vehicle in presbyopic subjects. Subjects will be treated for at least 6 weeks.

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
178 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CSF-1
Arm Type
Experimental
Arm Description
One drop bilaterally twice daily for approximately 6 weeks
Arm Title
Vehicle
Arm Type
Placebo Comparator
Arm Description
One drop bilaterally twice daily for approximately 6 weeks
Intervention Type
Drug
Intervention Name(s)
CSF-1
Intervention Description
One drop bilaterally twice daily for approximately 6 weeks
Intervention Type
Drug
Intervention Name(s)
Vehicle
Intervention Description
One drop bilaterally twice daily for approximately 6 weeks
Primary Outcome Measure Information:
Title
Number of participants with treatment emergent adverse events.
Time Frame
Week 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects must have presbyopia Exclusion Criteria: Have any contraindications to the study medications or diagnoses that would confound the study data
Facility Information:
Facility Name
Orasis Investigative Site
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Facility Name
Orasis Investigative Site
City
Petaluma
State/Province
California
ZIP/Postal Code
94954
Country
United States
Facility Name
Orasis Investigative Site
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80907
Country
United States
Facility Name
Orasis Investigative Site
City
Danbury
State/Province
Connecticut
ZIP/Postal Code
06810
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
Rock Island
State/Province
Illinois
ZIP/Postal Code
61201
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
Elizabeth City
State/Province
North Carolina
ZIP/Postal Code
27909
Country
United States
Facility Name
Orasis Investigative Site
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58103
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
Kingston
State/Province
Pennsylvania
ZIP/Postal Code
18704
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
Cedar Park
State/Province
Texas
ZIP/Postal Code
78613
Country
United States

12. IPD Sharing Statement

Learn more about this trial

An Evaluation of the Safety of CSF-1 in Presbyopic Subjects

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