An Evaluation of the Safety of CSF-1 in Presbyopic Subjects
NCT05393895 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 178
Last updated 2025-06-11
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.
Conditions
Interventions
- DRUG
-
CSF-1
One drop bilaterally twice daily for at least 6 weeks
- DRUG
-
Vehicle
One drop bilaterally twice daily for at least 6 weeks
Sponsors & Collaborators
-
Orasis Pharmaceuticals Ltd.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 40 Years
- Max Age
- 64 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-04-22
- Primary Completion
- 2022-12-01
- Completion
- 2022-12-01
- FDA Drug
- Yes
Countries
- United States
Study Locations
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