Trial · NCT05393895
An Evaluation of the Safety of CSF-1 in Presbyopic Subjects
NCT05393895, Phase 3, Completed, Orasis Pharmaceuticals Ltd.; results first posted 2025-06-11
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. An Evaluation of the Safety of CSF-1 in Presbyopic Subjects. Trials, record NCT05393895. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05393895
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- An Evaluation of the Safety of CSF-1 in Presbyopic Subjects
- NCT number
- NCT05393895
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 178 participants, actual
- Lead sponsor
- Orasis Pharmaceuticals Ltd.
- Conditions
- Presbyopia
- Interventions
- CSF-1, Vehicle
- First posted
- 2022-05-26
- Last updated
- 2025-06-11
- Results first posted
- 2025-06-11
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Treatment Emergent Adverse Events. | 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. |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Treatment Emergent Adverse Events. | Adverse events were collected over a period of at least 6 weeks and up to 21 weeks for the last participants exiting the study. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events. | CSF-1 | 43 | Participants | ||
| Number of Participants With Treatment Emergent Adverse Events. | Vehicle | 16 | Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | CSF-1 | 118 | 236 |
| Overall Study | STARTED | Vehicle | 60 | 120 |
| Overall Study | COMPLETED | CSF-1 | 110 | 220 |
| Overall Study | COMPLETED | Vehicle | 50 | 100 |
| Overall Study | NOT COMPLETED | CSF-1 | 8 | 16 |
| Overall Study | NOT COMPLETED | Vehicle | 10 | 20 |
Source ClinicalTrials.gov
Adverse events10
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Conjunctival hyperaemia | Eye disorders | CSF-1 | 2 | 118 | |
| other | Conjunctival hyperaemia | Eye disorders | Vehicle | 3 | 60 | |
| other | Conjuctival papillae | Eye disorders | CSF-1 | 3 | 118 | |
| other | Conjuctival papillae | Eye disorders | Vehicle | 4 | 60 | |
| other | Vision blurred | Eye disorders | CSF-1 | 5 | 118 | |
| other | Vision blurred | Eye disorders | Vehicle | 5 | 60 | |
| other | Instillation site pain | General disorders | CSF-1 | 21 | 118 | |
| other | Instillation site pain | General disorders | Vehicle | 0 | 60 | |
| other | COVID-19 | Infections and infestations | CSF-1 | 1 | 118 | |
| other | COVID-19 | Infections and infestations | Vehicle | 3 | 60 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | CSF-1 | 0 | 118 |
| Total, all-cause mortality | Vehicle | 0 | 60 |
| Total, other adverse events | CSF-1 | 21 | 118 |
| Total, other adverse events | Vehicle | 15 | 60 |
| Total, serious adverse events | CSF-1 | 0 | 118 |
| Total, serious adverse events | Vehicle | 0 | 60 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| CSF-1 vs Vehicle: Number of Participants With Treatment Emergent Adverse Events. | Trial comparisons |
| CSF-1 vs Vehicle: deaths from any cause | Trial comparisons |
| CSF-1 vs Vehicle: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05393895
GET https://conductscience.org/api/trials/v1/NCT05393895/registered