PresbyopiaPhase 3NCT05393895
An Evaluation of the Safety of CSF-1 in Presbyopic Subjects
A Phase 3 study testing CSF-1 in people with Presbyopia, run by Orasis Pharmaceuticals Ltd. at 12 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 to 64 years
- Conditions the study is for
- Presbyopia
- What is being tested?
- CSF-1
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 178 participants
- Where
- 12 sitesUnited States
- Study dates
- 22 Apr 2022to 1 Dec 2022
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Subjects must have presbyopia
Who cannot join
- Have any contraindications to the study medications or diagnoses that would confound the study data
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Orasis Investigative Site
Cedar Park, Texas, 78613
Orasis Investigative Site
Colorado Springs, Colorado, 80907
Orasis Investigative Site
Cranberry Township, Pennsylvania, 16066
Orasis Investigative Site
Danbury, Connecticut, 06810
Orasis Investigative Site
Elizabeth City, North Carolina, 27909
Orasis Investigative Site
Fargo, North Dakota, 58103
Orasis Investigative Site
Kingston, Pennsylvania, 18704
Orasis Investigative Site
Memphis, Tennessee, 38119
Orasis Investigative Site
Newport Beach, California, 92663
Orasis Investigative Site
Overland Park, Kansas, 66210
Orasis Investigative Site
Petaluma, California, 94954
Orasis Investigative Site
Rock Island, Illinois, 61201
About this study
Official title: A Multi-Center, Double-Masked, Vehicle-Controlled, 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.
- Conditions
- Presbyopia
- Being tested
- CSF-1, Vehicle
- Medical subject headings
- Presbyopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CSF-1Drug
Also called Qlosi
One drop bilaterally twice daily for at least 6 weeks
VehicleDrug
One drop bilaterally twice daily for at least 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| CSF-1 | Experimental | One drop bilaterally twice daily for at least 6 weeks Receives: Drug: CSF-1 |
| Vehicle | Placebo comparator | One drop bilaterally twice daily for at least 6 weeks Receives: Drug: Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment Emergent Adverse Events.
As this is a safety study, no efficacy outcome has been defined.
Measured: Adverse events were collected over a period of at least 6 weeks and up to 21 weeks for the last participants exiting the study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2022
- Study start22 Apr 2022
- Primary completion1 Dec 2022
- Study completion1 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PresbyopiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 178 participants (actual)
Sponsor and investigators
- Lead sponsor
- Orasis Pharmaceuticals Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05393895
- Sponsor's protocol ID
- 21-150-0005
- Status last verified
- Dec 2022
- First submitted
- 10 May 2022
- Last updated
- 11 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Double-Masked, Vehicle-Controlled, Evaluation of the Safety of CSF-1 in Presbyopic Subjects
- ClinicalTrials.gov ID
- NCT05393895
- Acronym / sponsor ID
- 21-150-0005
- Conditions
- Presbyopia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 178 participants (actual)
- Lead sponsor
- Orasis Pharmaceuticals Ltd.Industry (pharma, biotech, devices)
- Study start
- 22 Apr 2022 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 26 May 2022 (actual)
- Results
- Posted 11 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CSF-1 | Experimental | Drug: CSF-1One drop bilaterally twice daily for at least 6 weeks |
| Vehicle | Placebo comparator | Drug: VehicleOne drop bilaterally twice daily for at least 6 weeks |
Who may qualify
- Ages
- 40 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Subjects must have presbyopia
Key exclusion criteria (1 listed)
- Have any contraindications to the study medications or diagnoses that would confound the study data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CSF-1Also: QlosiOne drop bilaterally twice daily for at least 6 weeks | Drug | CSF-1 |
| VehicleOne drop bilaterally twice daily for at least 6 weeks | Drug | Vehicle |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing CSF-1 in people with Presbyopia, run by Orasis Pharmaceuticals Ltd. at 12 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2025.