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Cytokine

CSF-1 for Presbyopia

Phase 3
Waitlist Available
Research Sponsored by Orasis Pharmaceuticals Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subjects must have presbyopia
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 6
Awards & highlights

Study Summary

This trial will test how safe and effective a new eye drop is in people with presbyopia, or age-related farsightedness.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 6
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 6 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Therapeutic procedure

Side effects data

From 2022 Phase 3 trial • 309 Patients • NCT04599933
1%
Enteritis
1%
instillation site pain
1%
headache
100%
80%
60%
40%
20%
0%
Study treatment Arm
Vehicle
CSF-1

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: CSF-1Experimental Treatment1 Intervention
One drop bilaterally twice daily for approximately 6 weeks
Group II: VehiclePlacebo Group1 Intervention
One drop bilaterally twice daily for approximately 6 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CSF-1
2022
Completed Phase 3
~960

Find a Location

Who is running the clinical trial?

Orasis Pharmaceuticals Ltd.Lead Sponsor
5 Previous Clinical Trials
851 Total Patients Enrolled
5 Trials studying Presbyopia
851 Patients Enrolled for Presbyopia

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many study participants are taking part in this clinical trial?

"Yes, the information available on clinicaltrials.gov demonstrates that this clinical trial is presently looking for individuals to take part. The clinical trial was initially posted on 4/22/2022 and was most recently edited on 9/27/2022. The clinical trial is admitting 495 participants across 17 sites."

Answered by AI

Is this trial only open to seniors, or can younger patients participate as well?

"In order to be eligible for this trial, patients must fall between the ages of 40 and 64, as stipulated in the inclusion criteria."

Answered by AI

Would I be a good fit for this research project?

"Up to 495 people aged between 40 and 64 who have presbyopia can participate in this study. Most notably, applicants must meet the following eligibility criteria: Subjects must have presbyopia."

Answered by AI

Are people with the qualifying condition still able to join this trial?

"Yes, this study is currently looking for participants and is regularly updated, with the most recent changes happening on September 27th, 2022."

Answered by AI

Has the CSF-1 drug been cleared by the FDA?

"CSF-1 is classified as having a level 3 safety rating. This is due to the fact that it is a phase 3 trial, which means that there is both evidence of efficacy and repeated trials supporting its safety."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
An Evaluation of the Safety of CSF-1 in Presbyopic Subjects
2022. "An Evaluation of the Safety of CSF-1 in Presbyopic Subjects". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05393895.
~59 spots leftby Apr 2025
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