Trial Outcomes & Findings for An Evaluation of the Safety of CSF-1 in Presbyopic Subjects (NCT NCT05393895)
NCT ID: NCT05393895
Last Updated: 2025-06-11
Results Overview
As this is a safety study, no efficacy outcome has been defined.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
178 participants
Primary outcome timeframe
Adverse events were collected over a period of at least 6 weeks and up to 21 weeks for the last participants exiting the study.
Results posted on
2025-06-11
Participant Flow
Unit of analysis: eyes
Participant milestones
| Measure |
CSF-1
One drop bilaterally twice daily for at least 6 weeks
CSF-1: One drop bilaterally twice daily for at least 6 weeks
|
Vehicle
One drop bilaterally twice daily for at least 6 weeks
Vehicle: One drop bilaterally twice daily for at least 6 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
118 236
|
60 120
|
|
Overall Study
COMPLETED
|
110 220
|
50 100
|
|
Overall Study
NOT COMPLETED
|
8 16
|
10 20
|
Reasons for withdrawal
| Measure |
CSF-1
One drop bilaterally twice daily for at least 6 weeks
CSF-1: One drop bilaterally twice daily for at least 6 weeks
|
Vehicle
One drop bilaterally twice daily for at least 6 weeks
Vehicle: One drop bilaterally twice daily for at least 6 weeks
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
3
|
|
Overall Study
Lost to Follow-up
|
4
|
3
|
|
Overall Study
Protocol Violation
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
4
|
Baseline Characteristics
An Evaluation of the Safety of CSF-1 in Presbyopic Subjects
Baseline characteristics by cohort
| Measure |
CSF-1
n=118 eyes
One drop bilaterally twice daily for at least 6 weeks
CSF-1: One drop bilaterally twice daily for at least 6 weeks
|
Vehicle
n=60 eyes
One drop bilaterally twice daily for at least 6 weeks
Vehicle: One drop bilaterally twice daily for at least 6 weeks
|
Total
n=178 eyes
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54.3 years
STANDARD_DEVIATION 5.52 • n=5 Participants
|
54.3 years
STANDARD_DEVIATION 5.55 • n=7 Participants
|
54.3 years
STANDARD_DEVIATION 5.51 • n=5 Participants
|
|
Sex: Female, Male
Female
|
71 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
115 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
47 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
113 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
172 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
26 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
89 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
140 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
118 participants
n=5 Participants
|
60 participants
n=7 Participants
|
178 participants
n=5 Participants
|
|
Iris Color
Light Iris Color
|
63 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
96 Participants
n=5 Participants
|
|
Iris Color
Dark Iris Color
|
55 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
82 Participants
n=5 Participants
|
|
Manifest Refraction Spherical Equivalent (MRSE)
-4.5D to <-0.5D
|
24 eyes
n=32 eyes
|
14 eyes
n=16 eyes
|
38 eyes
n=48 eyes
|
|
Manifest Refraction Spherical Equivalent (MRSE)
-0.5D to <= +0.75D
|
67 eyes
n=32 eyes
|
35 eyes
n=16 eyes
|
102 eyes
n=48 eyes
|
|
Manifest Refraction Spherical Equivalent (MRSE)
> +0.75D to +2.0D
|
27 eyes
n=32 eyes
|
11 eyes
n=16 eyes
|
38 eyes
n=48 eyes
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
CSF-1
n=118 Participants
One drop bilaterally twice daily for at least 6 weeks
CSF-1: One drop bilaterally twice daily for at least 6 weeks
|
Vehicle
n=60 Participants
One drop bilaterally twice daily for at least 6 weeks
Vehicle: One drop bilaterally twice daily for at least 6 weeks
|
|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events.
|
43 Participants
|
16 Participants
|
Adverse Events
CSF-1
Serious events: 0 serious events
Other events: 21 other events
Deaths: 0 deaths
Vehicle
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
CSF-1
n=118 participants at risk
One drop bilaterally twice daily for at least 6 weeks
CSF-1: One drop bilaterally twice daily for at least 6 weeks
|
Vehicle
n=60 participants at risk
One drop bilaterally twice daily for at least 6 weeks
Vehicle: One drop bilaterally twice daily for at least 6 weeks
|
|---|---|---|
|
Eye disorders
Conjunctival hyperaemia
|
1.7%
2/118 • Adverse events were collected over a period of at least 6 weeks and up to 21 weeks for the last participants exiting the study.
|
5.0%
3/60 • Adverse events were collected over a period of at least 6 weeks and up to 21 weeks for the last participants exiting the study.
|
|
Eye disorders
Conjuctival papillae
|
2.5%
3/118 • Adverse events were collected over a period of at least 6 weeks and up to 21 weeks for the last participants exiting the study.
|
6.7%
4/60 • Adverse events were collected over a period of at least 6 weeks and up to 21 weeks for the last participants exiting the study.
|
|
Eye disorders
Vision blurred
|
4.2%
5/118 • Adverse events were collected over a period of at least 6 weeks and up to 21 weeks for the last participants exiting the study.
|
8.3%
5/60 • Adverse events were collected over a period of at least 6 weeks and up to 21 weeks for the last participants exiting the study.
|
|
General disorders
Instillation site pain
|
17.8%
21/118 • Adverse events were collected over a period of at least 6 weeks and up to 21 weeks for the last participants exiting the study.
|
0.00%
0/60 • Adverse events were collected over a period of at least 6 weeks and up to 21 weeks for the last participants exiting the study.
|
|
Infections and infestations
COVID-19
|
0.85%
1/118 • Adverse events were collected over a period of at least 6 weeks and up to 21 weeks for the last participants exiting the study.
|
5.0%
3/60 • Adverse events were collected over a period of at least 6 weeks and up to 21 weeks for the last participants exiting the study.
|
Additional Information
Head of Regulatory Affairs
Orasis Pharmaceuticals, Ltd.
Phone: +972-9-8877745
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place