Trial Outcomes & Findings for A Multi-Center, Double-Masked Evaluation of the Efficacy and Safety of CSF-1 in the Treatment of Presbyopia (NCT NCT03885011)
NCT ID: NCT03885011
Last Updated: 2023-01-26
Results Overview
Number of subjects with a ≥ 3-line gain in near BDCVA (at 40 cm) at 1 hour post dose after 1 week treatment with CSF-1-Fixed Dose Combination (FDC) low dose (pilocarpine HCl 0.2% + diclofenac 0.006%) or pilocarpine HCl 0.2% alone or diclofenac 0.006% alone
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
166 participants
Primary outcome timeframe
1 hour post dose on day 8
Results posted on
2023-01-26
Participant Flow
Participant milestones
| Measure |
CSF-1-FDC
pilocarpine HCl + diclofenac Na (fixed dose combination), 1 drop in each eye administered 2 times a day
|
Pilo
pilocarpine HCl (alone), 1 drop in each eye administered 2 times a day
|
Diclo
diclofenac Na (serves as control group), 1 drop in each eye administered 2 times a day
|
|---|---|---|---|
|
Overall Study
STARTED
|
53
|
55
|
58
|
|
Overall Study
COMPLETED
|
52
|
52
|
57
|
|
Overall Study
NOT COMPLETED
|
1
|
3
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Multi-Center, Double-Masked Evaluation of the Efficacy and Safety of CSF-1 in the Treatment of Presbyopia
Baseline characteristics by cohort
| Measure |
CSF-1-FDC
n=53 Participants
pilocarpine HCl + diclofenac Na (fixed dose combination)
|
Pilo
n=55 Participants
pilocarpine HCl (alone)
|
Diclo
n=58 Participants
diclofenac Na (serves as control group)
|
Total
n=166 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
54.8 years
STANDARD_DEVIATION 3.96 • n=5 Participants
|
54.9 years
STANDARD_DEVIATION 4.93 • n=7 Participants
|
54.1 years
STANDARD_DEVIATION 4.94 • n=5 Participants
|
54.6 years
STANDARD_DEVIATION 4.63 • n=4 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
102 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
64 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
52 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
162 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 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
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
41 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
134 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
53 participants
n=5 Participants
|
55 participants
n=7 Participants
|
58 participants
n=5 Participants
|
166 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 1 hour post dose on day 8Population: The primary analysis was conducted on the per protocol (PP) study population set and therefore the number of subjects is slightly different than from the overall participant flow.
Number of subjects with a ≥ 3-line gain in near BDCVA (at 40 cm) at 1 hour post dose after 1 week treatment with CSF-1-Fixed Dose Combination (FDC) low dose (pilocarpine HCl 0.2% + diclofenac 0.006%) or pilocarpine HCl 0.2% alone or diclofenac 0.006% alone
Outcome measures
| Measure |
CSF-1-FDC
n=51 Participants
pilocarpine HCl + diclofenac Na (fixed dose combination)
|
Pilo
n=50 Participants
pilocarpine HCl (alone)
|
Diclo
n=56 Participants
diclofenac Na (serves as control group)
|
|---|---|---|---|
|
Number of Subjects With ≥ 3 Lines Gain in Near Best Distance Corrected Visual Acuity (BDCVA) (at 40 cm)
|
10 Participants
|
12 Participants
|
10 Participants
|
PRIMARY outcome
Timeframe: 1 hour post dose on day 15Population: The primary analysis was conducted on the per protocol (PP) study population set and therefore the number of subjects is slightly different than from the overall participants flow.
Number of subjects with a ≥ 3-line gain in near BDCVA (at 40 cm) at 1 hour post dose after 1 week treatment with CSF-1-FDC (pilocarpine HCl 0.4% + diclofenac 0.006%) or pilocarpine HCl 0.4% alone or diclofenac 0.006% alone
Outcome measures
| Measure |
CSF-1-FDC
n=51 Participants
pilocarpine HCl + diclofenac Na (fixed dose combination)
|
Pilo
n=49 Participants
pilocarpine HCl (alone)
|
Diclo
n=56 Participants
diclofenac Na (serves as control group)
|
|---|---|---|---|
|
Number of Subjects With ≥ 3 Lines Gain in BDCVA (at 40 cm)
|
22 Participants
|
23 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: 1 hour post dose on day 8Population: The analysis was conducted on the per protocol (PP) study population set and therefore the number of subjects is slightly different than from the overall participants flow.
Number of subjects with a ≥ 2-line gain in near BDCVA (at 40 cm0 at 1 hour post dose after 1 week treatment with CSF-1-FDC (pilocarpine HCl 0.2% + diclofenac 0.006%) or pilocarpine HCl 0.2% alone or diclofenac 0.006% alone
Outcome measures
| Measure |
CSF-1-FDC
n=51 Participants
pilocarpine HCl + diclofenac Na (fixed dose combination)
|
Pilo
n=50 Participants
pilocarpine HCl (alone)
|
Diclo
n=56 Participants
diclofenac Na (serves as control group)
|
|---|---|---|---|
|
Number of Subjects With ≥ 2 Lines Gain in BDCVA (at 40 cm)
|
24 Participants
|
25 Participants
|
18 Participants
|
SECONDARY outcome
Timeframe: 1 hour post dose on day 15Population: The analysis was conducted on the per protocol (PP) study population set and therefore the number of subjects is slightly different than from the overall participants flow.
Number of subjects with a ≥ 2-line gain in near BDCVA (at 40 cm) at 1 hour post dose after 1 week treatment with CSF-1-FDC (pilocarpine HCl 0.4% + diclofenac 0.006%) or pilocarpine HCl 0.4% alone or diclofenac 0.006% alone
Outcome measures
| Measure |
CSF-1-FDC
n=51 Participants
pilocarpine HCl + diclofenac Na (fixed dose combination)
|
Pilo
n=49 Participants
pilocarpine HCl (alone)
|
Diclo
n=56 Participants
diclofenac Na (serves as control group)
|
|---|---|---|---|
|
Number of Subjects With ≥ 2 Lines Gain in BDCVA (at 40 cm)
|
35 Participants
|
39 Participants
|
24 Participants
|
Adverse Events
CSF-1-FDC
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Pilo
Serious events: 1 serious events
Other events: 13 other events
Deaths: 1 deaths
Diclo
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CSF-1-FDC
n=53 participants at risk
pilocarpine HCl + diclofenac Na (fixed dose combination)
|
Pilo
n=55 participants at risk
pilocarpine HCl (alone)
|
Diclo
n=58 participants at risk
diclofenac Na (serves as control group)
|
|---|---|---|---|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/53 • During the 2 weeks duration of the study.
Treatment emergent adverse events (TEAEs) reported, elicited, and observed during clinical visits. In the CSF-1-FDC and the pilocarpine alone groups, TEAEs are reported for both doses of pilocarpine, as no separate analysis for TEAEs reported on Day 8 and Day 15 was planned in the protocol or statistical analysis plan.
|
1.8%
1/55 • Number of events 1 • During the 2 weeks duration of the study.
Treatment emergent adverse events (TEAEs) reported, elicited, and observed during clinical visits. In the CSF-1-FDC and the pilocarpine alone groups, TEAEs are reported for both doses of pilocarpine, as no separate analysis for TEAEs reported on Day 8 and Day 15 was planned in the protocol or statistical analysis plan.
|
0.00%
0/58 • During the 2 weeks duration of the study.
Treatment emergent adverse events (TEAEs) reported, elicited, and observed during clinical visits. In the CSF-1-FDC and the pilocarpine alone groups, TEAEs are reported for both doses of pilocarpine, as no separate analysis for TEAEs reported on Day 8 and Day 15 was planned in the protocol or statistical analysis plan.
|
Other adverse events
| Measure |
CSF-1-FDC
n=53 participants at risk
pilocarpine HCl + diclofenac Na (fixed dose combination)
|
Pilo
n=55 participants at risk
pilocarpine HCl (alone)
|
Diclo
n=58 participants at risk
diclofenac Na (serves as control group)
|
|---|---|---|---|
|
Eye disorders
Conjunctival hyperemia
|
5.7%
3/53 • During the 2 weeks duration of the study.
Treatment emergent adverse events (TEAEs) reported, elicited, and observed during clinical visits. In the CSF-1-FDC and the pilocarpine alone groups, TEAEs are reported for both doses of pilocarpine, as no separate analysis for TEAEs reported on Day 8 and Day 15 was planned in the protocol or statistical analysis plan.
|
3.6%
2/55 • During the 2 weeks duration of the study.
Treatment emergent adverse events (TEAEs) reported, elicited, and observed during clinical visits. In the CSF-1-FDC and the pilocarpine alone groups, TEAEs are reported for both doses of pilocarpine, as no separate analysis for TEAEs reported on Day 8 and Day 15 was planned in the protocol or statistical analysis plan.
|
0.00%
0/58 • During the 2 weeks duration of the study.
Treatment emergent adverse events (TEAEs) reported, elicited, and observed during clinical visits. In the CSF-1-FDC and the pilocarpine alone groups, TEAEs are reported for both doses of pilocarpine, as no separate analysis for TEAEs reported on Day 8 and Day 15 was planned in the protocol or statistical analysis plan.
|
|
Eye disorders
Vision blurred
|
1.9%
1/53 • During the 2 weeks duration of the study.
Treatment emergent adverse events (TEAEs) reported, elicited, and observed during clinical visits. In the CSF-1-FDC and the pilocarpine alone groups, TEAEs are reported for both doses of pilocarpine, as no separate analysis for TEAEs reported on Day 8 and Day 15 was planned in the protocol or statistical analysis plan.
|
10.9%
6/55 • During the 2 weeks duration of the study.
Treatment emergent adverse events (TEAEs) reported, elicited, and observed during clinical visits. In the CSF-1-FDC and the pilocarpine alone groups, TEAEs are reported for both doses of pilocarpine, as no separate analysis for TEAEs reported on Day 8 and Day 15 was planned in the protocol or statistical analysis plan.
|
5.2%
3/58 • During the 2 weeks duration of the study.
Treatment emergent adverse events (TEAEs) reported, elicited, and observed during clinical visits. In the CSF-1-FDC and the pilocarpine alone groups, TEAEs are reported for both doses of pilocarpine, as no separate analysis for TEAEs reported on Day 8 and Day 15 was planned in the protocol or statistical analysis plan.
|
|
General disorders
Instillation site pain
|
9.4%
5/53 • During the 2 weeks duration of the study.
Treatment emergent adverse events (TEAEs) reported, elicited, and observed during clinical visits. In the CSF-1-FDC and the pilocarpine alone groups, TEAEs are reported for both doses of pilocarpine, as no separate analysis for TEAEs reported on Day 8 and Day 15 was planned in the protocol or statistical analysis plan.
|
5.5%
3/55 • During the 2 weeks duration of the study.
Treatment emergent adverse events (TEAEs) reported, elicited, and observed during clinical visits. In the CSF-1-FDC and the pilocarpine alone groups, TEAEs are reported for both doses of pilocarpine, as no separate analysis for TEAEs reported on Day 8 and Day 15 was planned in the protocol or statistical analysis plan.
|
3.4%
2/58 • During the 2 weeks duration of the study.
Treatment emergent adverse events (TEAEs) reported, elicited, and observed during clinical visits. In the CSF-1-FDC and the pilocarpine alone groups, TEAEs are reported for both doses of pilocarpine, as no separate analysis for TEAEs reported on Day 8 and Day 15 was planned in the protocol or statistical analysis plan.
|
|
Nervous system disorders
Headache
|
1.9%
1/53 • During the 2 weeks duration of the study.
Treatment emergent adverse events (TEAEs) reported, elicited, and observed during clinical visits. In the CSF-1-FDC and the pilocarpine alone groups, TEAEs are reported for both doses of pilocarpine, as no separate analysis for TEAEs reported on Day 8 and Day 15 was planned in the protocol or statistical analysis plan.
|
9.1%
5/55 • During the 2 weeks duration of the study.
Treatment emergent adverse events (TEAEs) reported, elicited, and observed during clinical visits. In the CSF-1-FDC and the pilocarpine alone groups, TEAEs are reported for both doses of pilocarpine, as no separate analysis for TEAEs reported on Day 8 and Day 15 was planned in the protocol or statistical analysis plan.
|
3.4%
2/58 • During the 2 weeks duration of the study.
Treatment emergent adverse events (TEAEs) reported, elicited, and observed during clinical visits. In the CSF-1-FDC and the pilocarpine alone groups, TEAEs are reported for both doses of pilocarpine, as no separate analysis for TEAEs reported on Day 8 and Day 15 was planned in the protocol or statistical analysis plan.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60