Phase 3 N=178 Randomized Double-blind Treatment

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

Presbyopia

Bottom Line

View on ClinicalTrials.gov: NCT05393895 ↗

Enrolled (actual)

178

Serious AEs

0.0%

Results posted

Jun 2025

Primary outcome: Primary: Number of Participants With Treatment Emergent Adverse Events. — 43; 16 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: CSF-1 (Drug); Vehicle (Drug)
Age: Adult · 40+ yrs
Sex: All
Sponsor: Orasis Pharmaceuticals Ltd.
Primary completion: Dec 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Treatment Emergent Adverse Events.	43; 16	—

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.

Eligibility Criteria

Inclusion Criteria

Subjects must have presbyopia

Exclusion Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05393895). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.