Presbyopia
Conditions
Brief summary
This is a 4-visit, multi-center, randomized, double-masked, vehicle-controlled study evaluating the safety and efficacy of CSF-1 in the temporary correction of presbyopia.
Interventions
DRUGCSF-1
One drop bilaterally twice daily for approximately 2 weeks.
DRUGVehicle
One drop bilaterally twice daily for approximately 2 weeks.
Sponsors
Orasis Pharmaceuticals Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
45 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
* Subjects must have presbyopia.
Exclusion criteria
Subjects must not: * Have any contraindications to the study medications or diagnoses that would confound the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects With a ≥ 3-line Gain in BDCVA (Best Distance-Corrected Visual Acuity) at 40cm and no Loss in BDCVA ≥ 5 Letters at 4m on Day 8, 1 Hour Post-Dose 1. | Baseline (Day 1) to Day 8 (1 hour post-Dose 1) | The primary end-point was measured on Day 8, 1 hour post first CSF-1 dose, as the number of participants who are responders to the treatment. A responder was defined as as subject with a ≥ 3-line gain in BDCVA (Best Distance-Corrected Visual Acuity) at 40cm and no loss in BDCVA ≥ 5 letters at 4m. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects With a ≥ 3-line Gain in BDCVA at 40cm and no Loss in BDCVA ≥ 5 Letters at 4m. | Baseline (Day 1) to Day 8 (2 hours post-Dose 1) | The key secondary endpoints were measured on Day 8 at different time points and were the percentage of subjects with a ≥ 3-line (15-letter) gain, from baseline, in BDCVA at 40 cm (Precision Vision Chart) and no loss in BDCVA ≥ 5 letters (ETDRS chart at 4 m) in the study eye. |
| Percentage of Subjects With a ≥ 3-line Gain in BDCVA at 40cm and no Loss in BDCVA ≥ 5 Letters at 4m on Day 8 at 1 Hour Post-Dose 2 | Baseline (Day 1) to Day 8 (1 hour post Dose 2; Dose 2 occurred 2 hours following Dose 1) | The key secondary endpoints were measured on Day 8 at different time points and were the percentage of subjects with a ≥ 3-line (15-letter) gain, from baseline, in BDCVA at 40 cm (Precision Vision Chart) and no loss in BDCVA ≥ 5 letters (ETDRS chart at 4 m) in the study eye. |
| Percentage of Subjects With a ≥ 3-line Gain in BDCVA at 40cm and no Loss in BDCVA ≥ 5 Letters at 4m on Day 8 at 2 Hours Post-dose 2 | Baseline (Day 1) to Day 8 (2 hours post Dose 2; Dose 2 occurred 2 hours following Dose 1) | The key secondary endpoints were measured on Day 8 at different time points and were the percentage of subjects with a ≥ 3-line (15-letter) gain, from baseline, in BDCVA at 40 cm (Precision Vision Chart) and no loss in BDCVA ≥ 5 letters (ETDRS chart at 4 m) in the study eye. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| CSF-1 One drop bilaterally twice daily for approximately 2 weeks.
CSF-1: One drop bilaterally twice daily for approximately 2 weeks. | 154 |
| Vehicle One drop bilaterally twice daily for approximately 2 weeks.
Vehicle: One drop bilaterally twice daily for approximately 2 weeks. | 150 |
| Total | 304 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 1 |
| Overall Study | Lost to Follow-up | 1 | 6 |
| Overall Study | Other reason | 1 | 0 |
| Overall Study | Protocol Violation | 1 | 0 |
| Overall Study | Withdrawal by Subject | 6 | 1 |
Baseline characteristics
| Characteristic | Total | CSF-1 | Vehicle |
|---|---|---|---|
| Age, Continuous | 54.7 years STANDARD_DEVIATION 4.89 | 54.6 years STANDARD_DEVIATION 4.97 | 54.8 years STANDARD_DEVIATION 4.81 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 58 Participants | 30 Participants | 28 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 246 Participants | 124 Participants | 122 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Iris Color Brown Iris Color | 142 Participants | 72 Participants | 70 Participants |
| Iris Color Light Iris Color | 162 Participants | 82 Participants | 80 Participants |
| Manifest Refraction Spherical Equivalent (MRSE) -0.5 D to <= +0.75 D | 180 Participants | 91 Participants | 89 Participants |
| Manifest Refraction Spherical Equivalent (MRSE) > +0.75 D to +2.0 D | 63 Participants | 32 Participants | 31 Participants |
| Manifest Refraction Spherical Equivalent (MRSE) -4.5 D to < -0.5 D | 61 Participants | 31 Participants | 30 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 12 Participants | 5 Participants | 7 Participants |
| Race (NIH/OMB) Black or African American | 22 Participants | 13 Participants | 9 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 3 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 263 Participants | 131 Participants | 132 Participants |
| Region of Enrollment United States | 304 participants | 154 participants | 150 participants |
| Sex: Female, Male Female | 195 Participants | 101 Participants | 94 Participants |
| Sex: Female, Male Male | 109 Participants | 53 Participants | 56 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 153 | 0 / 151 |
| other Total, other adverse events | 35 / 153 | 2 / 151 |
| serious Total, serious adverse events | 0 / 153 | 1 / 151 |
Outcome results
Primary
Percentage of Subjects With a ≥ 3-line Gain in BDCVA (Best Distance-Corrected Visual Acuity) at 40cm and no Loss in BDCVA ≥ 5 Letters at 4m on Day 8, 1 Hour Post-Dose 1.
The primary end-point was measured on Day 8, 1 hour post first CSF-1 dose, as the number of participants who are responders to the treatment. A responder was defined as as subject with a ≥ 3-line gain in BDCVA (Best Distance-Corrected Visual Acuity) at 40cm and no loss in BDCVA ≥ 5 letters at 4m.
Time frame: Baseline (Day 1) to Day 8 (1 hour post-Dose 1)
Population: Full analysis set (FAS): included all randomized subjects who received at least 1 dose of the study drug. Subjects in the FAS were analyzed as randomized.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CSF-1 | Percentage of Subjects With a ≥ 3-line Gain in BDCVA (Best Distance-Corrected Visual Acuity) at 40cm and no Loss in BDCVA ≥ 5 Letters at 4m on Day 8, 1 Hour Post-Dose 1. | 64 Participants |
| Vehicle | Percentage of Subjects With a ≥ 3-line Gain in BDCVA (Best Distance-Corrected Visual Acuity) at 40cm and no Loss in BDCVA ≥ 5 Letters at 4m on Day 8, 1 Hour Post-Dose 1. | 32 Participants |
Comparison: All treatment comparisons for primary and secondary endpoints related to BDCVA were conducted with a logistic regression model including fixed effects of baseline BDCVA at 40 cm as a covariate and treatment.p-value: <0.0195% CI: [1.753, 5.064]Regression, Logistic
Secondary
Percentage of Subjects With a ≥ 3-line Gain in BDCVA at 40cm and no Loss in BDCVA ≥ 5 Letters at 4m.
The key secondary endpoints were measured on Day 8 at different time points and were the percentage of subjects with a ≥ 3-line (15-letter) gain, from baseline, in BDCVA at 40 cm (Precision Vision Chart) and no loss in BDCVA ≥ 5 letters (ETDRS chart at 4 m) in the study eye.
Time frame: Baseline (Day 1) to Day 8 (2 hours post-Dose 1)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CSF-1 | Percentage of Subjects With a ≥ 3-line Gain in BDCVA at 40cm and no Loss in BDCVA ≥ 5 Letters at 4m. | 62 Participants |
| Vehicle | Percentage of Subjects With a ≥ 3-line Gain in BDCVA at 40cm and no Loss in BDCVA ≥ 5 Letters at 4m. | 31 Participants |
p-value: <0.0195% CI: [1.655, 4.762]Regression, Logistic
Secondary
Percentage of Subjects With a ≥ 3-line Gain in BDCVA at 40cm and no Loss in BDCVA ≥ 5 Letters at 4m on Day 8 at 1 Hour Post-Dose 2
The key secondary endpoints were measured on Day 8 at different time points and were the percentage of subjects with a ≥ 3-line (15-letter) gain, from baseline, in BDCVA at 40 cm (Precision Vision Chart) and no loss in BDCVA ≥ 5 letters (ETDRS chart at 4 m) in the study eye.
Time frame: Baseline (Day 1) to Day 8 (1 hour post Dose 2; Dose 2 occurred 2 hours following Dose 1)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CSF-1 | Percentage of Subjects With a ≥ 3-line Gain in BDCVA at 40cm and no Loss in BDCVA ≥ 5 Letters at 4m on Day 8 at 1 Hour Post-Dose 2 | 80 Participants |
| Vehicle | Percentage of Subjects With a ≥ 3-line Gain in BDCVA at 40cm and no Loss in BDCVA ≥ 5 Letters at 4m on Day 8 at 1 Hour Post-Dose 2 | 25 Participants |
p-value: <0.0195% CI: [3.431, 10.499]Regression, Logistic
Secondary
Percentage of Subjects With a ≥ 3-line Gain in BDCVA at 40cm and no Loss in BDCVA ≥ 5 Letters at 4m on Day 8 at 2 Hours Post-dose 2
The key secondary endpoints were measured on Day 8 at different time points and were the percentage of subjects with a ≥ 3-line (15-letter) gain, from baseline, in BDCVA at 40 cm (Precision Vision Chart) and no loss in BDCVA ≥ 5 letters (ETDRS chart at 4 m) in the study eye.
Time frame: Baseline (Day 1) to Day 8 (2 hours post Dose 2; Dose 2 occurred 2 hours following Dose 1)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CSF-1 | Percentage of Subjects With a ≥ 3-line Gain in BDCVA at 40cm and no Loss in BDCVA ≥ 5 Letters at 4m on Day 8 at 2 Hours Post-dose 2 | 71 Participants |
| Vehicle | Percentage of Subjects With a ≥ 3-line Gain in BDCVA at 40cm and no Loss in BDCVA ≥ 5 Letters at 4m on Day 8 at 2 Hours Post-dose 2 | 29 Participants |
p-value: <0.0195% CI: [2.404, 7.204]Regression, Logistic