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

NCT ID: NCT05393895

Last Updated: 2025-06-11

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

178 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-22

Study Completion Date

2022-12-01

Brief Summary

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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.

Detailed Description

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Conditions

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Presbyopia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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CSF-1

One drop bilaterally twice daily for at least 6 weeks

Group Type EXPERIMENTAL

CSF-1

Intervention Type DRUG

One drop bilaterally twice daily for at least 6 weeks

Vehicle

One drop bilaterally twice daily for at least 6 weeks

Group Type PLACEBO_COMPARATOR

Vehicle

Intervention Type DRUG

One drop bilaterally twice daily for at least 6 weeks

Interventions

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CSF-1

One drop bilaterally twice daily for at least 6 weeks

Intervention Type DRUG

Vehicle

One drop bilaterally twice daily for at least 6 weeks

Intervention Type DRUG

Other Intervention Names

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Qlosi

Eligibility Criteria

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Inclusion Criteria

* Subjects must have presbyopia

Exclusion Criteria

* Have any contraindications to the study medications or diagnoses that would confound the study data
Minimum Eligible Age

40 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Orasis Pharmaceuticals Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Orasis Investigative Site

Newport Beach, California, United States

Site Status

Orasis Investigative Site

Petaluma, California, United States

Site Status

Orasis Investigative Site

Colorado Springs, Colorado, United States

Site Status

Orasis Investigative Site

Danbury, Connecticut, United States

Site Status

Orasis Investigative Site

Rock Island, Illinois, United States

Site Status

Orasis Investigative Site

Overland Park, Kansas, United States

Site Status

Orasis Investigative Site

Elizabeth City, North Carolina, United States

Site Status

Orasis Investigative Site

Fargo, North Dakota, United States

Site Status

Orasis Investigative Site

Cranberry Township, Pennsylvania, United States

Site Status

Orasis Investigative Site

Kingston, Pennsylvania, United States

Site Status

Orasis Investigative Site

Memphis, Tennessee, United States

Site Status

Orasis Investigative Site

Cedar Park, Texas, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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21-150-0005

Identifier Type: -

Identifier Source: org_study_id

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