Trial Outcomes & Findings for An Evaluation of the Efficacy and Safety of CSF-1 in the Temporary Correction of Presbyopia (NEAR-1) (NCT NCT04599933)
NCT ID: NCT04599933
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
309 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
|
155
|
154
|
|
Overall Study
COMPLETED
|
146
|
147
|
|
Overall Study
NOT COMPLETED
|
9
|
7
|
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
Adverse Event
|
4
|
1
|
|
Overall Study
Withdrawal by Subject
|
4
|
2
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Physician Decision
|
0
|
1
|
|
Overall Study
Screen Failure
|
1
|
2
|
Baseline Characteristics
An Evaluation of the Efficacy and Safety of CSF-1 in the Temporary Correction of Presbyopia (NEAR-1)
Baseline characteristics by cohort
| Measure |
CSF-1
n=155 Participants
One drop bilaterally twice daily for approximately 2 weeks.
CSF-1: One drop bilaterally twice daily for approximately 2 weeks.
|
Vehicle
n=154 Participants
One drop bilaterally twice daily for approximately 2 weeks.
Vehicle: One drop bilaterally twice daily for approximately 2 weeks.
|
Total
n=309 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54.8 years
STANDARD_DEVIATION 4.56 • n=5 Participants
|
54.5 years
STANDARD_DEVIATION 4.88 • n=7 Participants
|
54.7 years
STANDARD_DEVIATION 4.72 • n=5 Participants
|
|
Sex: Female, Male
Female
|
93 Participants
n=5 Participants
|
92 Participants
n=7 Participants
|
185 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
62 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
124 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
33 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
122 Participants
n=5 Participants
|
131 Participants
n=7 Participants
|
253 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
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
25 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
121 Participants
n=5 Participants
|
111 Participants
n=7 Participants
|
232 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
155 participants
n=5 Participants
|
154 participants
n=7 Participants
|
309 participants
n=5 Participants
|
|
Iris Color
Light Iris Color
|
71 Participants
n=5 Participants
|
70 Participants
n=7 Participants
|
141 Participants
n=5 Participants
|
|
Iris Color
Dark Iris Color
|
84 Participants
n=5 Participants
|
84 Participants
n=7 Participants
|
168 Participants
n=5 Participants
|
|
Manifest Refraction Spherical Equivalent (MRSE)
-4.5 D to < -0.5 D
|
35 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
|
Manifest Refraction Spherical Equivalent (MRSE)
-0.5 D to <= +0.75 D
|
88 Participants
n=5 Participants
|
90 Participants
n=7 Participants
|
178 Participants
n=5 Participants
|
|
Manifest Refraction Spherical Equivalent (MRSE)
> +0.75 D to +2.0 D
|
32 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
64 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=155 Participants
One drop bilaterally twice daily for approximately 2 weeks.
CSF-1: One drop bilaterally twice daily for approximately 2 weeks.
|
Vehicle
n=154 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.
|
60 Participants
|
26 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=155 Participants
One drop bilaterally twice daily for approximately 2 weeks.
CSF-1: One drop bilaterally twice daily for approximately 2 weeks.
|
Vehicle
n=154 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 1
|
61 Participants
|
26 Participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1) to Day 8 (1 hour post-Dose 2; Dose 2 occurs 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=155 Participants
One drop bilaterally twice daily for approximately 2 weeks.
CSF-1: One drop bilaterally twice daily for approximately 2 weeks.
|
Vehicle
n=154 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
|
74 Participants
|
24 Participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1) to Day 8 (2 hours post-Dose 2; Dose 2 occurs 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=155 Participants
One drop bilaterally twice daily for approximately 2 weeks.
CSF-1: One drop bilaterally twice daily for approximately 2 weeks.
|
Vehicle
n=154 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
|
60 Participants
|
23 Participants
|
Adverse Events
CSF-1
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Vehicle
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CSF-1
n=155 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=154 participants at risk
One drop bilaterally twice daily for approximately 2 weeks.
Vehicle: One drop bilaterally twice daily for approximately 2 weeks.
|
|---|---|---|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/155 • 15 days
|
0.65%
1/154 • Number of events 1 • 15 days
|
Other adverse events
| Measure |
CSF-1
n=155 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=154 participants at risk
One drop bilaterally twice daily for approximately 2 weeks.
Vehicle: One drop bilaterally twice daily for approximately 2 weeks.
|
|---|---|---|
|
General disorders
instillation site pain
|
5.8%
9/155 • 15 days
|
0.65%
1/154 • 15 days
|
|
Nervous system disorders
headache
|
5.2%
8/155 • 15 days
|
1.3%
2/154 • 15 days
|
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