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

December 13, 2022 updated by: Orasis Pharmaceuticals Ltd.

A Multi-Center, Double-Masked, Vehicle-Controlled, Evaluation of the Safety of CSF-1 in Presbyopic Subjects

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

178

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Newport Beach, California, United States, 92663
        • Orasis Investigative Site
      • Petaluma, California, United States, 94954
        • Orasis Investigative Site
    • Colorado
      • Colorado Springs, Colorado, United States, 80907
        • Orasis Investigative Site
    • Connecticut
      • Danbury, Connecticut, United States, 06810
        • Orasis Investigative Site
    • Florida
      • Mount Dora, Florida, United States, 32757
        • Orasis Investigative Site
    • Illinois
      • Rock Island, Illinois, United States, 61201
        • Orasis Investigative Site
    • Kansas
      • Overland Park, Kansas, United States, 66210
        • Orasis Investigative Site
    • North Carolina
      • Elizabeth City, North Carolina, United States, 27909
        • Orasis Investigative Site
    • North Dakota
      • Fargo, North Dakota, United States, 58103
        • Orasis Investigative Site
    • Pennsylvania
      • Cranberry Township, Pennsylvania, United States, 16066
        • Orasis Investigative Site
      • Kingston, Pennsylvania, United States, 18704
        • Orasis Investigative Site
    • Tennessee
      • Memphis, Tennessee, United States, 38119
        • Orasis Investigative Site
    • Texas
      • Cedar Park, Texas, United States, 78613
        • Orasis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

38 years to 62 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subjects must have presbyopia

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CSF-1
One drop bilaterally twice daily for approximately 6 weeks
Drug: CSF-1
One drop bilaterally twice daily for approximately 6 weeks
Placebo Comparator: Vehicle
One drop bilaterally twice daily for approximately 6 weeks
Drug: Vehicle
One drop bilaterally twice daily for approximately 6 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of participants with treatment emergent adverse events.
Time Frame: Week 6
Week 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Orasis Pharmaceuticals Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 22, 2022

Primary Completion (Actual)

December 1, 2022

Study Completion (Actual)

December 1, 2022

Study Registration Dates

First Submitted

May 10, 2022

First Submitted That Met QC Criteria

May 23, 2022

First Posted (Actual)

May 26, 2022

Study Record Updates

Last Update Posted (Actual)

December 15, 2022

Last Update Submitted That Met QC Criteria

December 13, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21-150-0005

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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