An Evaluation of the Efficacy and Safety of CSF-1 in the Temporary Correction of Presbyopia (NEAR-1)

Orasis Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Presbyopia

Treatments: Drug: Vehicle; Drug: CSF-1

Study type: Interventional

Funder types: Industry

Identifiers

NCT04599933

20-150-0002

Details and patient eligibility

About

This is a 4-visit, multi-center, randomized, double-masked, vehicle-controlled study evaluating the safety and efficacy of CSF-1 in the temporary correction of presbyopia.

Enrollment: 309 patients

Sex: All

Ages: 45 to 64 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects must have presbyopia.

Exclusion criteria

Subjects must not:

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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309 participants in 2 patient groups, including a placebo group

CSF-1

Experimental group

Description:

One drop bilaterally twice daily for approximately 2 weeks.

Treatment:

Drug: CSF-1

Vehicle

Placebo Comparator group

Description:

One drop bilaterally twice daily for approximately 2 weeks.

Treatment:

Drug: Vehicle