Trial Outcomes & Findings for An Evaluation of the Efficacy and Safety of CSF-1 in the Temporary Correction of Presbyopia (NEAR-2) (NCT NCT04599972)
NCT ID: NCT04599972
Last Updated: 2024-04-04
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
304 participants
Primary outcome timeframe
Baseline (Day 1) to Day 8 (1 hour post-Dose 1)
Results posted on
2024-04-04
Participant Flow
Participant milestones
| Measure |
CSF-1
One drop bilaterally twice daily for approximately 2 weeks.
CSF-1: One drop bilaterally twice daily for approximately 2 weeks.
|
Vehicle
One drop bilaterally twice daily for approximately 2 weeks.
Vehicle: One drop bilaterally twice daily for approximately 2 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
154
|
150
|
|
Overall Study
COMPLETED
|
144
|
142
|
|
Overall Study
NOT COMPLETED
|
10
|
8
|
Reasons for withdrawal
| Measure |
CSF-1
One drop bilaterally twice daily for approximately 2 weeks.
CSF-1: One drop bilaterally twice daily for approximately 2 weeks.
|
Vehicle
One drop bilaterally twice daily for approximately 2 weeks.
Vehicle: One drop bilaterally twice daily for approximately 2 weeks.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
6
|
1
|
|
Overall Study
Adverse Event
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
6
|
|
Overall Study
Protocol Violation
|
1
|
0
|
|
Overall Study
Other reason
|
1
|
0
|
Baseline Characteristics
An Evaluation of the Efficacy and Safety of CSF-1 in the Temporary Correction of Presbyopia (NEAR-2)
Baseline characteristics by cohort
| Measure |
CSF-1
n=154 Participants
One drop bilaterally twice daily for approximately 2 weeks.
CSF-1: One drop bilaterally twice daily for approximately 2 weeks.
|
Vehicle
n=150 Participants
One drop bilaterally twice daily for approximately 2 weeks.
Vehicle: One drop bilaterally twice daily for approximately 2 weeks.
|
Total
n=304 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54.6 years
STANDARD_DEVIATION 4.97 • n=5 Participants
|
54.8 years
STANDARD_DEVIATION 4.81 • n=7 Participants
|
54.7 years
STANDARD_DEVIATION 4.89 • n=5 Participants
|
|
Sex: Female, Male
Female
|
101 Participants
n=5 Participants
|
94 Participants
n=7 Participants
|
195 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
53 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
109 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
30 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
124 Participants
n=5 Participants
|
122 Participants
n=7 Participants
|
246 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
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
13 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
131 Participants
n=5 Participants
|
132 Participants
n=7 Participants
|
263 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
154 participants
n=5 Participants
|
150 participants
n=7 Participants
|
304 participants
n=5 Participants
|
|
Iris Color
Light Iris Color
|
82 Participants
n=5 Participants
|
80 Participants
n=7 Participants
|
162 Participants
n=5 Participants
|
|
Iris Color
Brown Iris Color
|
72 Participants
n=5 Participants
|
70 Participants
n=7 Participants
|
142 Participants
n=5 Participants
|
|
Manifest Refraction Spherical Equivalent (MRSE)
-4.5 D to < -0.5 D
|
31 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
|
Manifest Refraction Spherical Equivalent (MRSE)
-0.5 D to <= +0.75 D
|
91 Participants
n=5 Participants
|
89 Participants
n=7 Participants
|
180 Participants
n=5 Participants
|
|
Manifest Refraction Spherical Equivalent (MRSE)
> +0.75 D to +2.0 D
|
32 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
CSF-1
n=154 Participants
One drop bilaterally twice daily for approximately 2 weeks.
CSF-1: One drop bilaterally twice daily for approximately 2 weeks.
|
Vehicle
n=150 Participants
One drop bilaterally twice daily for approximately 2 weeks.
Vehicle: One drop bilaterally twice daily for approximately 2 weeks.
|
|---|---|---|
|
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
|
32 Participants
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
CSF-1
n=154 Participants
One drop bilaterally twice daily for approximately 2 weeks.
CSF-1: One drop bilaterally twice daily for approximately 2 weeks.
|
Vehicle
n=150 Participants
One drop bilaterally twice daily for approximately 2 weeks.
Vehicle: One drop bilaterally twice daily for approximately 2 weeks.
|
|---|---|---|
|
Percentage of Subjects With a ≥ 3-line Gain in BDCVA at 40cm and no Loss in BDCVA ≥ 5 Letters at 4m.
|
62 Participants
|
31 Participants
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
CSF-1
n=154 Participants
One drop bilaterally twice daily for approximately 2 weeks.
CSF-1: One drop bilaterally twice daily for approximately 2 weeks.
|
Vehicle
n=150 Participants
One drop bilaterally twice daily for approximately 2 weeks.
Vehicle: One drop bilaterally twice daily for approximately 2 weeks.
|
|---|---|---|
|
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
|
25 Participants
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
CSF-1
n=154 Participants
One drop bilaterally twice daily for approximately 2 weeks.
CSF-1: One drop bilaterally twice daily for approximately 2 weeks.
|
Vehicle
n=150 Participants
One drop bilaterally twice daily for approximately 2 weeks.
Vehicle: One drop bilaterally twice daily for approximately 2 weeks.
|
|---|---|---|
|
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
|
29 Participants
|
Adverse Events
CSF-1
Serious events: 0 serious events
Other events: 35 other events
Deaths: 0 deaths
Vehicle
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CSF-1
n=153 participants at risk
One drop bilaterally twice daily for approximately 2 weeks.
CSF-1: One drop bilaterally twice daily for approximately 2 weeks.
|
Vehicle
n=151 participants at risk
One drop bilaterally twice daily for approximately 2 weeks.
Vehicle: One drop bilaterally twice daily for approximately 2 weeks.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
infective arthritis
|
0.00%
0/153 • 15 days
One subject was randomized to CSF-1 and inadvertently received Vehicle. For the safety results, the subjects were analyzed as treated (and not as randomized). Therefore the number of participants in each group is different from the numbers stated in the Participant Flow.
|
0.66%
1/151 • 15 days
One subject was randomized to CSF-1 and inadvertently received Vehicle. For the safety results, the subjects were analyzed as treated (and not as randomized). Therefore the number of participants in each group is different from the numbers stated in the Participant Flow.
|
Other adverse events
| Measure |
CSF-1
n=153 participants at risk
One drop bilaterally twice daily for approximately 2 weeks.
CSF-1: One drop bilaterally twice daily for approximately 2 weeks.
|
Vehicle
n=151 participants at risk
One drop bilaterally twice daily for approximately 2 weeks.
Vehicle: One drop bilaterally twice daily for approximately 2 weeks.
|
|---|---|---|
|
Eye disorders
vision blurred
|
7.2%
11/153 • 15 days
One subject was randomized to CSF-1 and inadvertently received Vehicle. For the safety results, the subjects were analyzed as treated (and not as randomized). Therefore the number of participants in each group is different from the numbers stated in the Participant Flow.
|
1.3%
2/151 • 15 days
One subject was randomized to CSF-1 and inadvertently received Vehicle. For the safety results, the subjects were analyzed as treated (and not as randomized). Therefore the number of participants in each group is different from the numbers stated in the Participant Flow.
|
|
General disorders
instillation site pain
|
5.9%
9/153 • 15 days
One subject was randomized to CSF-1 and inadvertently received Vehicle. For the safety results, the subjects were analyzed as treated (and not as randomized). Therefore the number of participants in each group is different from the numbers stated in the Participant Flow.
|
0.00%
0/151 • 15 days
One subject was randomized to CSF-1 and inadvertently received Vehicle. For the safety results, the subjects were analyzed as treated (and not as randomized). Therefore the number of participants in each group is different from the numbers stated in the Participant Flow.
|
|
Nervous system disorders
headache
|
9.8%
15/153 • 15 days
One subject was randomized to CSF-1 and inadvertently received Vehicle. For the safety results, the subjects were analyzed as treated (and not as randomized). Therefore the number of participants in each group is different from the numbers stated in the Participant Flow.
|
1.3%
2/151 • 15 days
One subject was randomized to CSF-1 and inadvertently received Vehicle. For the safety results, the subjects were analyzed as treated (and not as randomized). Therefore the number of participants in each group is different from the numbers stated in the Participant Flow.
|
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