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

Study results available
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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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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05393895 on ClinicalTrials.gov