Presbyopia
Conditions
Brief 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.
Interventions
DRUGCSF-1
One drop bilaterally twice daily for at least 6 weeks
DRUGVehicle
One drop bilaterally twice daily for at least 6 weeks
Sponsors
Orasis Pharmaceuticals Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
40 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
* Subjects must have presbyopia
Exclusion criteria
* Have any contraindications to the study medications or diagnoses that would confound the study data
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| CSF-1 One drop bilaterally twice daily for at least 6 weeks
CSF-1: One drop bilaterally twice daily for at least 6 weeks | 118 |
| CSF-1 One drop bilaterally twice daily for at least 6 weeks
CSF-1: One drop bilaterally twice daily for at least 6 weeks | 118 |
| Vehicle One drop bilaterally twice daily for at least 6 weeks
Vehicle: One drop bilaterally twice daily for at least 6 weeks | 60 |
| Vehicle One drop bilaterally twice daily for at least 6 weeks
Vehicle: One drop bilaterally twice daily for at least 6 weeks | 60 |
| Total | 356 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| 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
| Characteristic | Total | CSF-1 | Vehicle |
|---|---|---|---|
| Age, Continuous | 54.3 years STANDARD_DEVIATION 5.51 | 54.3 years STANDARD_DEVIATION 5.52 | 54.3 years STANDARD_DEVIATION 5.55 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants | 5 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 172 Participants | 113 Participants | 59 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Iris Color Dark Iris Color | 82 Participants | 55 Participants | 27 Participants |
| Iris Color Light Iris Color | 96 Participants | 63 Participants | 33 Participants |
| Manifest Refraction Spherical Equivalent (MRSE) -0.5D to <= +0.75D | 102 eyes | 67 eyes | 35 eyes |
| Manifest Refraction Spherical Equivalent (MRSE) > +0.75D to +2.0D | 38 eyes | 27 eyes | 11 eyes |
| Manifest Refraction Spherical Equivalent (MRSE) -4.5D to <-0.5D | 38 eyes | 24 eyes | 14 eyes |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 4 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 33 Participants | 26 Participants | 7 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 140 Participants | 89 Participants | 51 Participants |
| Region of Enrollment United States | 178 participants | 118 participants | 60 participants |
| Sex: Female, Male Female | 115 Participants | 71 Participants | 44 Participants |
| Sex: Female, Male Male | 63 Participants | 47 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 118 | 0 / 60 |
| other Total, other adverse events | 21 / 118 | 15 / 60 |
| serious Total, serious adverse events | 0 / 118 | 0 / 60 |
Outcome results
Primary
Number of Participants With Treatment Emergent Adverse Events.
As this is a safety study, no efficacy outcome has been defined.
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CSF-1 | Number of Participants With Treatment Emergent Adverse Events. | 43 Participants |
| Vehicle | Number of Participants With Treatment Emergent Adverse Events. | 16 Participants |