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

NCT04599933 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 309

Last updated 2024-04-04

Study results available
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Summary

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.

Conditions

Interventions

DRUG

CSF-1

One drop bilaterally twice daily for approximately 2 weeks.

DRUG

Vehicle

One drop bilaterally twice daily for approximately 2 weeks.

Sponsors & Collaborators

  • Orasis Pharmaceuticals Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-18
Primary Completion
2022-02-11
Completion
2022-02-19
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT04599933 on ClinicalTrials.gov