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Completed

NCT Number: NCT05393895

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

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.

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Key information

Conditions

Presbyopia Eye Diseases Refractive Errors

Age range

40 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Orasis Investigative Site, Newport Beach, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects must have presbyopia

Exclusion criteria

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

Treatment and study plan

CSF-1

Drug

One drop bilaterally twice daily for at least 6 weeks

Other names: Qlosi

Vehicle

Drug

One drop bilaterally twice daily for at least 6 weeks

Primary outcomes

  1. Number of Participants With Treatment Emergent Adverse Events.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Orasis Pharmaceuticals Ltd.

Industry

Registry information

Official study title

A Multi-Center, Double-Masked, Vehicle-Controlled, Evaluation of the Safety of CSF-1 in Presbyopic Subjects

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
May 26, 2022
Registry last updated
Jun 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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