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NCT05393895 Clinical Trial

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

Presbyopia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05393895
Other study ID # 21-150-0005
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date April 22, 2022
Est. completion date December 1, 2022

Study information
Verified date December 2022
Source Orasis Pharmaceuticals Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 178
Est. completion date December 1, 2022
Est. primary completion date December 1, 2022
Accepts healthy volunteers No
Gender All
Age group 40 Years to 64 Years
Eligibility Inclusion Criteria: - Subjects must have presbyopia Exclusion Criteria: - Have any contraindications to the study medications or diagnoses that would confound the study data

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• CSF-1
One drop bilaterally twice daily for approximately 6 weeks
• Vehicle
One drop bilaterally twice daily for approximately 6 weeks

Locations
Country Name City State
United States Orasis Investigative Site Cedar Park Texas
United States Orasis Investigative Site Colorado Springs Colorado
United States Orasis Investigative Site Cranberry Township Pennsylvania
United States Orasis Investigative Site Danbury Connecticut
United States Orasis Investigative Site Elizabeth City North Carolina
United States Orasis Investigative Site Fargo North Dakota
United States Orasis Investigative Site Kingston Pennsylvania
United States Orasis Investigative Site Memphis Tennessee
United States Orasis Investigative Site Mount Dora Florida
United States Orasis Investigative Site Newport Beach California
United States Orasis Investigative Site Overland Park Kansas
United States Orasis Investigative Site Petaluma California
United States Orasis Investigative Site Rock Island Illinois

Sponsors (1)
Lead Sponsor Collaborator
Orasis Pharmaceuticals Ltd.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of participants with treatment emergent adverse events. Week 6
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