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

Phase 3

Completed

• Conditions: Presbyopia
• Interventions: Drug: CSF-1; Drug: Vehicle

• Registration Number: NCT05393895
• Lead Sponsor: Orasis Pharmaceuticals Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-04-22
• Study First Submitted: 2022-05-10
• Study First Submitted QC: 2022-05-23
• Study First Posted: 2022-05-26
• Status Verified: 2022-12
• Primary Completion: 2022-12-01
• Study Completion: 2022-12-01
• Results First Submitted: 2024-10-30
• Results First Submitted QC: 2025-06-10
• Last Update Submitted: 2025-06-10
• Results First Posted: 2025-06-11
• Last Update Posted: 2025-06-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 178

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CSF-1	CSF-1	One drop bilaterally twice daily for at least 6 weeks
Vehicle	Vehicle	One drop bilaterally twice daily for at least 6 weeks

Primary Outcome Measures

Name	Time	Method
Number of Participants With Treatment Emergent Adverse Events.	Adverse events were collected over a period of at least 6 weeks and up to 21 weeks for the last participants exiting the study.	As this is a safety study, no efficacy outcome has been defined.

Trial Locations

Locations (1)

Orasis Investigative Site; 🇺🇸 Cedar Park, Texas, United States