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

Orasis Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Presbyopia

Treatments: Drug: Vehicle; Drug: CSF-1

Study type: Interventional

Funder types: Industry

Identifiers

NCT05393895

21-150-0005

Details and patient eligibility

About

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.

Enrollment: 178 patients

Sex: All

Ages: 40 to 64 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects must have presbyopia

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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178 participants in 2 patient groups, including a placebo group

CSF-1

Experimental group

Description:

One drop bilaterally twice daily for at least 6 weeks

Treatment:

Drug: CSF-1

Vehicle

Placebo Comparator group

Description:

One drop bilaterally twice daily for at least 6 weeks

Treatment:

Drug: Vehicle