Trial Outcomes & Findings for The Safety and Efficacy of SYD-101 in Children With Myopia (NCT NCT03918915)
NCT ID: NCT03918915
Last Updated: 2026-07-30
Results Overview
Proportion of participants with confirmed myopic progression \<-0.75 D (diopters), based on SE (spherical equivalent) as measured by cycloplegic autorefraction
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
852 participants
Primary outcome timeframe
Month 36
Results posted on
2026-07-30
Participant Flow
The Full Analysis Set (FAS) comprised of all participants who were randomized (N= 852) and received at least 1 dose of study drug (N=847).
Participant milestones
| Measure |
Part 1: SYD-101 0.01%
1 drop in each eye at bedtime. Part 1: participants will be randomized to SYD-101 0.01% Part 2: participants will be re-randomized to SYD-101 0.01% or Vehicle
SYD-101 0.01%: Sterile topical ophthalmic solution
|
Part 1: SYD-101 0.03%
1 drop in each eye at bedtime. Part 1: participants will be randomized to SYD-101 0.03% Part 2: participants will be re-randomized to SYD-101 0.03% or Vehicle
SYD-101 0.03%: Sterile topical ophthalmic solution
|
Part 1: Vehicle
1 drop in each eye at bedtime. Part 1: participants will be randomized to Vehicle Part 2: participants will be re-randomized to SYD-101 0.03%
Vehicle: Sterile topical ophthalmic solution without active ingredient
|
Part 2: SYD-101 0.01%
1 drop in each eye at bedtime.
50% of Part 1 participants who received SYD-101 0.01% will stay on SYD-101 0.01% in Part 2.
SYD-101 0.01%: Sterile topical ophthalmic solution
|
Part 2: SYD-101 0.03%
1 drop in each eye at bedtime.
50% of Part 1 participants who received SYD-101 0.03% will stay on SYD-101 0.03% in Part 2.
SYD-101 0.03%: Sterile topical ophthalmic solution
|
Part 2: 0.01% to Vehicle
1 drop in each eye at bedtime.
50% of Part 1 participants who received SYD-101 0.01% will be rerandomized to Vehicle in Part 2.
Vehicle: Sterile topical ophthalmic solution
|
Part 2: 0.03% to Vehicle
1 drop in each eye at bedtime.
50% of Part 1 participants who received SYD-101 0.03% will be rerandomized to Vehicle in Part 2.
Vehicle: Sterile topical ophthalmic solution
|
Part 2: Vehicle to SYD-101 0.03%
1 drop in each eye at bedtime.
All Part 1 participants who received Vehicle will be rerandomized to SYD-101 0.03% in Part 2.
SYD-101 0.03%: Sterile topical ophthalmic solution
|
|---|---|---|---|---|---|---|---|---|
|
Part 1: Baseline to Month 36
STARTED
|
284
|
285
|
283
|
0
|
0
|
0
|
0
|
0
|
|
Part 1: Baseline to Month 36
Received Study Medication
|
282
|
283
|
282
|
0
|
0
|
0
|
0
|
0
|
|
Part 1: Baseline to Month 36
Initiated Escape Medication
|
1
|
5
|
12
|
0
|
0
|
0
|
0
|
0
|
|
Part 1: Baseline to Month 36
COMPLETED
|
211
|
223
|
224
|
0
|
0
|
0
|
0
|
0
|
|
Part 1: Baseline to Month 36
NOT COMPLETED
|
73
|
62
|
59
|
0
|
0
|
0
|
0
|
0
|
|
Part 2: Mo 36 to Mo 48 (Withdrawal)
STARTED
|
0
|
0
|
0
|
102
|
105
|
103
|
105
|
205
|
|
Part 2: Mo 36 to Mo 48 (Withdrawal)
Continued Escape Medication
|
1
|
5
|
12
|
0
|
0
|
0
|
0
|
0
|
|
Part 2: Mo 36 to Mo 48 (Withdrawal)
Initiated Escape Medication
|
0
|
0
|
0
|
8
|
8
|
7
|
10
|
9
|
|
Part 2: Mo 36 to Mo 48 (Withdrawal)
COMPLETED
|
0
|
0
|
0
|
99
|
102
|
98
|
101
|
186
|
|
Part 2: Mo 36 to Mo 48 (Withdrawal)
NOT COMPLETED
|
0
|
0
|
0
|
3
|
3
|
5
|
4
|
19
|
Reasons for withdrawal
| Measure |
Part 1: SYD-101 0.01%
1 drop in each eye at bedtime. Part 1: participants will be randomized to SYD-101 0.01% Part 2: participants will be re-randomized to SYD-101 0.01% or Vehicle
SYD-101 0.01%: Sterile topical ophthalmic solution
|
Part 1: SYD-101 0.03%
1 drop in each eye at bedtime. Part 1: participants will be randomized to SYD-101 0.03% Part 2: participants will be re-randomized to SYD-101 0.03% or Vehicle
SYD-101 0.03%: Sterile topical ophthalmic solution
|
Part 1: Vehicle
1 drop in each eye at bedtime. Part 1: participants will be randomized to Vehicle Part 2: participants will be re-randomized to SYD-101 0.03%
Vehicle: Sterile topical ophthalmic solution without active ingredient
|
Part 2: SYD-101 0.01%
1 drop in each eye at bedtime.
50% of Part 1 participants who received SYD-101 0.01% will stay on SYD-101 0.01% in Part 2.
SYD-101 0.01%: Sterile topical ophthalmic solution
|
Part 2: SYD-101 0.03%
1 drop in each eye at bedtime.
50% of Part 1 participants who received SYD-101 0.03% will stay on SYD-101 0.03% in Part 2.
SYD-101 0.03%: Sterile topical ophthalmic solution
|
Part 2: 0.01% to Vehicle
1 drop in each eye at bedtime.
50% of Part 1 participants who received SYD-101 0.01% will be rerandomized to Vehicle in Part 2.
Vehicle: Sterile topical ophthalmic solution
|
Part 2: 0.03% to Vehicle
1 drop in each eye at bedtime.
50% of Part 1 participants who received SYD-101 0.03% will be rerandomized to Vehicle in Part 2.
Vehicle: Sterile topical ophthalmic solution
|
Part 2: Vehicle to SYD-101 0.03%
1 drop in each eye at bedtime.
All Part 1 participants who received Vehicle will be rerandomized to SYD-101 0.03% in Part 2.
SYD-101 0.03%: Sterile topical ophthalmic solution
|
|---|---|---|---|---|---|---|---|---|
|
Part 1: Baseline to Month 36
Adverse Event
|
0
|
5
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Part 1: Baseline to Month 36
Withdrawal by Subject
|
38
|
33
|
33
|
0
|
0
|
0
|
0
|
0
|
|
Part 1: Baseline to Month 36
Lost to Follow-up
|
31
|
22
|
21
|
0
|
0
|
0
|
0
|
0
|
|
Part 1: Baseline to Month 36
physician decision, non-compliance, moved
|
2
|
0
|
3
|
0
|
0
|
0
|
0
|
0
|
|
Part 1: Baseline to Month 36
Did not receive study medication
|
2
|
2
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Part 2: Mo 36 to Mo 48 (Withdrawal)
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
|
Part 2: Mo 36 to Mo 48 (Withdrawal)
Withdrawal by Subject
|
0
|
0
|
0
|
2
|
1
|
2
|
2
|
8
|
|
Part 2: Mo 36 to Mo 48 (Withdrawal)
Lost to Follow-up
|
0
|
0
|
0
|
1
|
2
|
3
|
1
|
7
|
|
Part 2: Mo 36 to Mo 48 (Withdrawal)
Physician Decision, Protocol Deviation, Non-Compliance, Other
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
2
|
Baseline Characteristics
The Safety and Efficacy of SYD-101 in Children With Myopia
Baseline characteristics by cohort
| Measure |
SYD-101 0.01%
n=282 Participants
1 drop in each eye at bedtime. Part 1: participants will be randomized to SYD-101 0.01% Part 2: participants will be re-randomized to SYD-101 0.01% or Vehicle
SYD-101 0.01%: Sterile topical ophthalmic solution
|
SYD-101 0.03%
n=283 Participants
1 drop in each eye at bedtime. Part 1: participants will be randomized to SYD-101 0.03% Part 2: participants will be re-randomized to SYD-101 0.03% or Vehicle
SYD-101 0.03%: Sterile topical ophthalmic solution
|
Vehicle
n=282 Participants
1 drop in each eye at bedtime. Part 1: participants will be randomized to Vehicle Part 2: participants will be re-randomized to SYD-101 0.03%
Vehicle: Sterile topical ophthalmic solution without active ingredient
|
Total
n=847 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
10.4 years
STANDARD_DEVIATION 2.44 • n=20 Participants
|
10.2 years
STANDARD_DEVIATION 2.46 • n=20 Participants
|
10.4 years
STANDARD_DEVIATION 2.42 • n=40 Participants
|
10.3 years
STANDARD_DEVIATION 2.44 • n=5 Participants
|
|
Sex: Female, Male
Female
|
167 Participants
n=20 Participants
|
156 Participants
n=20 Participants
|
149 Participants
n=40 Participants
|
472 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
115 Participants
n=20 Participants
|
127 Participants
n=20 Participants
|
133 Participants
n=40 Participants
|
375 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
74 Participants
n=20 Participants
|
71 Participants
n=20 Participants
|
81 Participants
n=40 Participants
|
226 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
208 Participants
n=20 Participants
|
212 Participants
n=20 Participants
|
201 Participants
n=40 Participants
|
621 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=20 Participants
|
3 Participants
n=20 Participants
|
4 Participants
n=40 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
46 Participants
n=20 Participants
|
55 Participants
n=20 Participants
|
47 Participants
n=40 Participants
|
148 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
35 Participants
n=20 Participants
|
22 Participants
n=20 Participants
|
21 Participants
n=40 Participants
|
78 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
190 Participants
n=20 Participants
|
192 Participants
n=20 Participants
|
198 Participants
n=40 Participants
|
580 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=20 Participants
|
8 Participants
n=20 Participants
|
4 Participants
n=40 Participants
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=20 Participants
|
3 Participants
n=20 Participants
|
6 Participants
n=40 Participants
|
13 Participants
n=5 Participants
|
|
Region of Enrollment
Austria
|
6 participants
n=20 Participants
|
10 participants
n=20 Participants
|
10 participants
n=40 Participants
|
26 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
263 participants
n=20 Participants
|
256 participants
n=20 Participants
|
258 participants
n=40 Participants
|
777 participants
n=5 Participants
|
|
Region of Enrollment
Slovakia
|
13 participants
n=20 Participants
|
17 participants
n=20 Participants
|
14 participants
n=40 Participants
|
44 participants
n=5 Participants
|
|
Baseline Spherical Equivalent
|
-2.73 Diopters
STANDARD_DEVIATION 1.375 • n=20 Participants
|
-2.65 Diopters
STANDARD_DEVIATION 1.286 • n=20 Participants
|
-2.70 Diopters
STANDARD_DEVIATION 1.267 • n=40 Participants
|
-2.69 Diopters
STANDARD_DEVIATION 1.309 • n=5 Participants
|
PRIMARY outcome
Timeframe: Month 36Population: Full Analysis Set. Intermittent missing observations were multiply imputed assuming MAR. Observations after use of escape/prohibited medications or treatments were imputed as having progressed. Observations after treatment or study discontinuation due to a related AE were imputed as having progressed. All other observations after treatment or study discontinuation were multiply imputed assuming MAR.
Proportion of participants with confirmed myopic progression \<-0.75 D (diopters), based on SE (spherical equivalent) as measured by cycloplegic autorefraction
Outcome measures
| Measure |
SYD-101 0.01%
n=282 Participants
1 drop in each eye at bedtime. Part 1: participants will be randomized to SYD-101 0.01% Part 2: participants will be re-randomized to SYD-101 0.01% or Vehicle
SYD-101 0.01%: Sterile topical ophthalmic solution
|
SYD-101 0.03%
n=283 Participants
1 drop in each eye at bedtime. Part 1: participants will be randomized to SYD-101 0.03% Part 2: participants will be re-randomized to SYD-101 0.03% or Vehicle
SYD-101 0.03%: Sterile topical ophthalmic solution
|
Vehicle
n=282 Participants
1 drop in each eye at bedtime. Part 1: participants will be randomized to Vehicle Part 2: participants will be re-randomized to SYD-101 0.03%
Vehicle: Sterile topical ophthalmic solution without active ingredient
|
|---|---|---|---|
|
Myopic Progression <-0.75 D (Diopters)
|
111 Participants
|
122 Participants
|
139 Participants
|
SECONDARY outcome
Timeframe: Month 36Population: Full Analysis Set
Mean annual progression rate of myopia measured in diopters: Spherical Equivalent (SE) as measured by cycloplegic autorefraction.
Outcome measures
| Measure |
SYD-101 0.01%
n=282 Participants
1 drop in each eye at bedtime. Part 1: participants will be randomized to SYD-101 0.01% Part 2: participants will be re-randomized to SYD-101 0.01% or Vehicle
SYD-101 0.01%: Sterile topical ophthalmic solution
|
SYD-101 0.03%
n=283 Participants
1 drop in each eye at bedtime. Part 1: participants will be randomized to SYD-101 0.03% Part 2: participants will be re-randomized to SYD-101 0.03% or Vehicle
SYD-101 0.03%: Sterile topical ophthalmic solution
|
Vehicle
n=282 Participants
1 drop in each eye at bedtime. Part 1: participants will be randomized to Vehicle Part 2: participants will be re-randomized to SYD-101 0.03%
Vehicle: Sterile topical ophthalmic solution without active ingredient
|
|---|---|---|---|
|
Mean Annual Myopic Progression
|
-0.30 Diopters/year
Interval -0.34 to -0.27
|
-0.32 Diopters/year
Interval -0.35 to -0.28
|
-0.38 Diopters/year
Interval -0.42 to -0.34
|
SECONDARY outcome
Timeframe: Through Month 36Population: Full Analysis Set
Proportion of participants with annual progression rate of myopia no worse than -0.50 D/year
Outcome measures
| Measure |
SYD-101 0.01%
n=282 Participants
1 drop in each eye at bedtime. Part 1: participants will be randomized to SYD-101 0.01% Part 2: participants will be re-randomized to SYD-101 0.01% or Vehicle
SYD-101 0.01%: Sterile topical ophthalmic solution
|
SYD-101 0.03%
n=283 Participants
1 drop in each eye at bedtime. Part 1: participants will be randomized to SYD-101 0.03% Part 2: participants will be re-randomized to SYD-101 0.03% or Vehicle
SYD-101 0.03%: Sterile topical ophthalmic solution
|
Vehicle
n=282 Participants
1 drop in each eye at bedtime. Part 1: participants will be randomized to Vehicle Part 2: participants will be re-randomized to SYD-101 0.03%
Vehicle: Sterile topical ophthalmic solution without active ingredient
|
|---|---|---|---|
|
Proportion of Participants With Annual Myopia Progression Rate >=-0.50 D/Year
|
240 Participants
|
238 Participants
|
227 Participants
|
SECONDARY outcome
Timeframe: Through Month 36Population: Full Analysis Set
Proportion of participants with annual progression rate of myopia no worse than -0.25D/year
Outcome measures
| Measure |
SYD-101 0.01%
n=282 Participants
1 drop in each eye at bedtime. Part 1: participants will be randomized to SYD-101 0.01% Part 2: participants will be re-randomized to SYD-101 0.01% or Vehicle
SYD-101 0.01%: Sterile topical ophthalmic solution
|
SYD-101 0.03%
n=283 Participants
1 drop in each eye at bedtime. Part 1: participants will be randomized to SYD-101 0.03% Part 2: participants will be re-randomized to SYD-101 0.03% or Vehicle
SYD-101 0.03%: Sterile topical ophthalmic solution
|
Vehicle
n=282 Participants
1 drop in each eye at bedtime. Part 1: participants will be randomized to Vehicle Part 2: participants will be re-randomized to SYD-101 0.03%
Vehicle: Sterile topical ophthalmic solution without active ingredient
|
|---|---|---|---|
|
Proportion of Participants With Annual Myopia Progression Rate >=-0.25 D/Year
|
163 Participants
|
150 Participants
|
131 Participants
|
SECONDARY outcome
Timeframe: Month 36Population: Full Analysis Set
Proportion of participants with increase of myopia more than -0.50D
Outcome measures
| Measure |
SYD-101 0.01%
n=282 Participants
1 drop in each eye at bedtime. Part 1: participants will be randomized to SYD-101 0.01% Part 2: participants will be re-randomized to SYD-101 0.01% or Vehicle
SYD-101 0.01%: Sterile topical ophthalmic solution
|
SYD-101 0.03%
n=283 Participants
1 drop in each eye at bedtime. Part 1: participants will be randomized to SYD-101 0.03% Part 2: participants will be re-randomized to SYD-101 0.03% or Vehicle
SYD-101 0.03%: Sterile topical ophthalmic solution
|
Vehicle
n=282 Participants
1 drop in each eye at bedtime. Part 1: participants will be randomized to Vehicle Part 2: participants will be re-randomized to SYD-101 0.03%
Vehicle: Sterile topical ophthalmic solution without active ingredient
|
|---|---|---|---|
|
Proportion of Participants With Increase of Myopia More Than -0.50 D
|
160 Participants
|
171 Participants
|
189 Participants
|
SECONDARY outcome
Timeframe: Up to 36 months (from date of randomization until date myopia progresses < -0.75 D)Population: Full Analysis Set. Participants were censored if they did not meet definition for confirmed myopic progression.
Time (days) to confirmed myopic progression of worse than -0.75D. Time to Progression (days) 95% CI is calculated for the median.
Outcome measures
| Measure |
SYD-101 0.01%
n=264 Participants
1 drop in each eye at bedtime. Part 1: participants will be randomized to SYD-101 0.01% Part 2: participants will be re-randomized to SYD-101 0.01% or Vehicle
SYD-101 0.01%: Sterile topical ophthalmic solution
|
SYD-101 0.03%
n=270 Participants
1 drop in each eye at bedtime. Part 1: participants will be randomized to SYD-101 0.03% Part 2: participants will be re-randomized to SYD-101 0.03% or Vehicle
SYD-101 0.03%: Sterile topical ophthalmic solution
|
Vehicle
n=262 Participants
1 drop in each eye at bedtime. Part 1: participants will be randomized to Vehicle Part 2: participants will be re-randomized to SYD-101 0.03%
Vehicle: Sterile topical ophthalmic solution without active ingredient
|
|---|---|---|---|
|
Time to Progression of Myopia <-0.75 D (Diopters)
|
NA Days
Interval 1101.0 to
Analyses for the median and upper bound of 95% CI could not be calculated since an insufficient number of participants achieved this myopic progression.
|
1112.0 Days
Interval 1099.0 to
Analyses for the upper bound of 95th CI could not be calculated since an insufficient number of participants achieved this myopic progression.
|
1104.0 Days
Interval 916.0 to
Analyses for the upper bound of 95th CI could not be calculated since an insufficient number of participants achieved this myopic progression.
|
SECONDARY outcome
Timeframe: Baseline to Month 36Population: Full Analysis Set of participants with axial length data
Mean change from baseline in axial length at sites with requisite equipment
Outcome measures
| Measure |
SYD-101 0.01%
n=127 Participants
1 drop in each eye at bedtime. Part 1: participants will be randomized to SYD-101 0.01% Part 2: participants will be re-randomized to SYD-101 0.01% or Vehicle
SYD-101 0.01%: Sterile topical ophthalmic solution
|
SYD-101 0.03%
n=128 Participants
1 drop in each eye at bedtime. Part 1: participants will be randomized to SYD-101 0.03% Part 2: participants will be re-randomized to SYD-101 0.03% or Vehicle
SYD-101 0.03%: Sterile topical ophthalmic solution
|
Vehicle
n=125 Participants
1 drop in each eye at bedtime. Part 1: participants will be randomized to Vehicle Part 2: participants will be re-randomized to SYD-101 0.03%
Vehicle: Sterile topical ophthalmic solution without active ingredient
|
|---|---|---|---|
|
Mean Change From Baseline in Axial Length (Subset Only)
|
0.46 millimeters
Interval 0.39 to 0.54
|
0.44 millimeters
Interval 0.36 to 0.51
|
0.48 millimeters
Interval 0.4 to 0.55
|
Adverse Events
Part 1: SYD-101 0.01%
Serious events: 4 serious events
Other events: 183 other events
Deaths: 0 deaths
Part 1: SYD-101 0.03%
Serious events: 10 serious events
Other events: 205 other events
Deaths: 0 deaths
Part 1: Vehicle
Serious events: 8 serious events
Other events: 194 other events
Deaths: 0 deaths
Escape Med: 0.03%
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Part 2: SYD-101 0.01%
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Part 2: SYD-101 0.03%
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Part 2: 0.01% to Vehicle
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Part 2: 0.03% to Vehicle
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Part 2: Vehicle to 0.03%
Serious events: 1 serious events
Other events: 60 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Part 1: SYD-101 0.01%
n=282 participants at risk
SYD-101, atropine sulphate, 0.01% ophthalmic solution
|
Part 1: SYD-101 0.03%
n=283 participants at risk
SYD-101, atropine sulphate, 0.03% ophthalmic solution
|
Part 1: Vehicle
n=282 participants at risk
Vehicle of SYD-101
|
Escape Med: 0.03%
n=50 participants at risk
Open-label escape medication
|
Part 2: SYD-101 0.01%
n=102 participants at risk
50% of Part 1 participants who received SYD-101 0.01% will stay on SYD-101 0.01% in Part 2.
SYD-101 0.01%: Sterile topical ophthalmic solution
|
Part 2: SYD-101 0.03%
n=105 participants at risk
50% of Part 1 participants who received SYD-101 0.03% will stay on SYD-101 0.03% in Part 2.
SYD-101 0.03%: Sterile topical ophthalmic solution
|
Part 2: 0.01% to Vehicle
n=103 participants at risk
50% of Part 1 participants who received SYD-101 0.01% will rerandomize to Vehicle in Part 2.
SYD-101 0.01%: Sterile topical ophthalmic solution
|
Part 2: 0.03% to Vehicle
n=105 participants at risk
50% of Part 1 participants who received SYD-101 0.01% will rerandomize to Vehicle in Part 2.
SYD-101 0.03%: Sterile topical ophthalmic solution
|
Part 2: Vehicle to 0.03%
n=205 participants at risk
All participants in Part 2 on Vehicle will rerandomized to SYD-101 0.03% in Part 2.
SYD-101 0.03%: Sterile topical ophthalmic solution
|
|---|---|---|---|---|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Fracture diamethaphyseos distillis radii
|
0.00%
0/282 • 48 months
|
0.35%
1/283 • Number of events 1 • 48 months
|
0.00%
0/282 • 48 months
|
0.00%
0/50 • 48 months
|
0.00%
0/102 • 48 months
|
0.00%
0/105 • 48 months
|
0.00%
0/103 • 48 months
|
0.00%
0/105 • 48 months
|
0.00%
0/205 • 48 months
|
|
Blood and lymphatic system disorders
Acute lymphadenitis
|
0.00%
0/282 • 48 months
|
0.35%
1/283 • Number of events 1 • 48 months
|
0.00%
0/282 • 48 months
|
0.00%
0/50 • 48 months
|
0.00%
0/102 • 48 months
|
0.00%
0/105 • 48 months
|
0.00%
0/103 • 48 months
|
0.00%
0/105 • 48 months
|
0.00%
0/205 • 48 months
|
|
General disorders
Pediatric inflammatory multisystem syndrome
|
0.00%
0/282 • 48 months
|
0.35%
1/283 • Number of events 1 • 48 months
|
0.00%
0/282 • 48 months
|
0.00%
0/50 • 48 months
|
0.00%
0/102 • 48 months
|
0.00%
0/105 • 48 months
|
0.00%
0/103 • 48 months
|
0.00%
0/105 • 48 months
|
0.00%
0/205 • 48 months
|
|
Infections and infestations
COVID 19
|
0.00%
0/282 • 48 months
|
0.35%
1/283 • Number of events 1 • 48 months
|
0.00%
0/282 • 48 months
|
0.00%
0/50 • 48 months
|
0.00%
0/102 • 48 months
|
0.00%
0/105 • 48 months
|
0.00%
0/103 • 48 months
|
0.00%
0/105 • 48 months
|
0.00%
0/205 • 48 months
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/282 • 48 months
|
0.00%
0/283 • 48 months
|
0.71%
2/282 • Number of events 2 • 48 months
|
0.00%
0/50 • 48 months
|
0.00%
0/102 • 48 months
|
0.00%
0/105 • 48 months
|
0.00%
0/103 • 48 months
|
0.00%
0/105 • 48 months
|
0.00%
0/205 • 48 months
|
|
Eye disorders
Transient vision loss
|
0.00%
0/282 • 48 months
|
0.00%
0/283 • 48 months
|
0.35%
1/282 • Number of events 1 • 48 months
|
0.00%
0/50 • 48 months
|
0.00%
0/102 • 48 months
|
0.00%
0/105 • 48 months
|
0.00%
0/103 • 48 months
|
0.00%
0/105 • 48 months
|
0.00%
0/205 • 48 months
|
|
Nervous system disorders
Dizziness on standing up
|
0.00%
0/282 • 48 months
|
0.00%
0/283 • 48 months
|
0.35%
1/282 • Number of events 1 • 48 months
|
0.00%
0/50 • 48 months
|
0.00%
0/102 • 48 months
|
0.00%
0/105 • 48 months
|
0.00%
0/103 • 48 months
|
0.00%
0/105 • 48 months
|
0.00%
0/205 • 48 months
|
|
Injury, poisoning and procedural complications
Fall off of high bar at gymnastics
|
0.00%
0/282 • 48 months
|
0.00%
0/283 • 48 months
|
0.35%
1/282 • Number of events 1 • 48 months
|
0.00%
0/50 • 48 months
|
0.00%
0/102 • 48 months
|
0.00%
0/105 • 48 months
|
0.00%
0/103 • 48 months
|
0.00%
0/105 • 48 months
|
0.00%
0/205 • 48 months
|
|
Injury, poisoning and procedural complications
Compound fracture of radius and ulna
|
0.00%
0/282 • 48 months
|
0.00%
0/283 • 48 months
|
0.35%
1/282 • Number of events 1 • 48 months
|
0.00%
0/50 • 48 months
|
0.00%
0/102 • 48 months
|
0.00%
0/105 • 48 months
|
0.00%
0/103 • 48 months
|
0.00%
0/105 • 48 months
|
0.00%
0/205 • 48 months
|
|
Nervous system disorders
Ataxia
|
0.00%
0/282 • 48 months
|
0.00%
0/283 • 48 months
|
0.35%
1/282 • Number of events 1 • 48 months
|
0.00%
0/50 • 48 months
|
0.00%
0/102 • 48 months
|
0.00%
0/105 • 48 months
|
0.00%
0/103 • 48 months
|
0.00%
0/105 • 48 months
|
0.00%
0/205 • 48 months
|
|
Infections and infestations
Pneumonia aspiration
|
0.00%
0/282 • 48 months
|
0.00%
0/283 • 48 months
|
0.00%
0/282 • 48 months
|
0.00%
0/50 • 48 months
|
0.00%
0/102 • 48 months
|
0.00%
0/105 • 48 months
|
0.00%
0/103 • 48 months
|
0.00%
0/105 • 48 months
|
0.49%
1/205 • Number of events 1 • 48 months
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.00%
0/282 • 48 months
|
0.00%
0/283 • 48 months
|
0.00%
0/282 • 48 months
|
0.00%
0/50 • 48 months
|
0.00%
0/102 • 48 months
|
0.00%
0/105 • 48 months
|
0.00%
0/103 • 48 months
|
0.00%
0/105 • 48 months
|
0.49%
1/205 • Number of events 1 • 48 months
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.00%
0/282 • 48 months
|
0.00%
0/283 • 48 months
|
0.00%
0/282 • 48 months
|
0.00%
0/50 • 48 months
|
0.00%
0/102 • 48 months
|
0.00%
0/105 • 48 months
|
0.00%
0/103 • 48 months
|
0.00%
0/105 • 48 months
|
0.49%
1/205 • Number of events 1 • 48 months
|
|
Injury, poisoning and procedural complications
Pulmonary contusion
|
0.00%
0/282 • 48 months
|
0.00%
0/283 • 48 months
|
0.00%
0/282 • 48 months
|
0.00%
0/50 • 48 months
|
0.00%
0/102 • 48 months
|
0.00%
0/105 • 48 months
|
0.00%
0/103 • 48 months
|
0.00%
0/105 • 48 months
|
0.49%
1/205 • Number of events 1 • 48 months
|
|
Nervous system disorders
Optic neuritis
|
0.00%
0/282 • 48 months
|
0.35%
1/283 • Number of events 1 • 48 months
|
0.00%
0/282 • 48 months
|
0.00%
0/50 • 48 months
|
0.00%
0/102 • 48 months
|
0.00%
0/105 • 48 months
|
0.00%
0/103 • 48 months
|
0.00%
0/105 • 48 months
|
0.00%
0/205 • 48 months
|
|
Gastrointestinal disorders
Ulcerative colitis
|
0.35%
1/282 • Number of events 1 • 48 months
|
0.00%
0/283 • 48 months
|
0.00%
0/282 • 48 months
|
0.00%
0/50 • 48 months
|
0.00%
0/102 • 48 months
|
0.00%
0/105 • 48 months
|
0.00%
0/103 • 48 months
|
0.00%
0/105 • 48 months
|
0.49%
1/205 • Number of events 4 • 48 months
|
|
Injury, poisoning and procedural complications
Non fatal intentional drug overdose
|
0.35%
1/282 • Number of events 1 • 48 months
|
0.00%
0/283 • 48 months
|
0.35%
1/282 • Number of events 1 • 48 months
|
0.00%
0/50 • 48 months
|
0.00%
0/102 • 48 months
|
0.00%
0/105 • 48 months
|
0.00%
0/103 • 48 months
|
0.00%
0/105 • 48 months
|
0.00%
0/205 • 48 months
|
|
Nervous system disorders
Seizure
|
0.00%
0/282 • 48 months
|
0.35%
1/283 • Number of events 1 • 48 months
|
0.00%
0/282 • 48 months
|
0.00%
0/50 • 48 months
|
0.00%
0/102 • 48 months
|
0.00%
0/105 • 48 months
|
0.00%
0/103 • 48 months
|
0.00%
0/105 • 48 months
|
0.00%
0/205 • 48 months
|
|
Injury, poisoning and procedural complications
Commotio cerebri
|
0.35%
1/282 • Number of events 1 • 48 months
|
0.00%
0/283 • 48 months
|
0.00%
0/282 • 48 months
|
0.00%
0/50 • 48 months
|
0.00%
0/102 • 48 months
|
0.00%
0/105 • 48 months
|
0.00%
0/103 • 48 months
|
0.00%
0/105 • 48 months
|
0.00%
0/205 • 48 months
|
|
Eye disorders
Papilledema
|
0.35%
1/282 • Number of events 1 • 48 months
|
0.00%
0/283 • 48 months
|
0.00%
0/282 • 48 months
|
0.00%
0/50 • 48 months
|
0.00%
0/102 • 48 months
|
0.00%
0/105 • 48 months
|
0.00%
0/103 • 48 months
|
0.00%
0/105 • 48 months
|
0.00%
0/205 • 48 months
|
|
Psychiatric disorders
Eating disorder
|
0.00%
0/282 • 48 months
|
0.35%
1/283 • Number of events 1 • 48 months
|
0.00%
0/282 • 48 months
|
0.00%
0/50 • 48 months
|
0.00%
0/102 • 48 months
|
0.00%
0/105 • 48 months
|
0.00%
0/103 • 48 months
|
0.00%
0/105 • 48 months
|
0.00%
0/205 • 48 months
|
|
Psychiatric disorders
Attempted suicide
|
0.00%
0/282 • 48 months
|
0.35%
1/283 • Number of events 1 • 48 months
|
0.00%
0/282 • 48 months
|
0.00%
0/50 • 48 months
|
0.00%
0/102 • 48 months
|
0.00%
0/105 • 48 months
|
0.00%
0/103 • 48 months
|
0.00%
0/105 • 48 months
|
0.00%
0/205 • 48 months
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/282 • 48 months
|
0.35%
1/283 • Number of events 1 • 48 months
|
0.00%
0/282 • 48 months
|
0.00%
0/50 • 48 months
|
0.00%
0/102 • 48 months
|
0.00%
0/105 • 48 months
|
0.00%
0/103 • 48 months
|
0.00%
0/105 • 48 months
|
0.00%
0/205 • 48 months
|
|
Congenital, familial and genetic disorders
Medically correct pectus escavatum
|
0.00%
0/282 • 48 months
|
0.35%
1/283 • Number of events 1 • 48 months
|
0.00%
0/282 • 48 months
|
0.00%
0/50 • 48 months
|
0.00%
0/102 • 48 months
|
0.00%
0/105 • 48 months
|
0.00%
0/103 • 48 months
|
0.00%
0/105 • 48 months
|
0.00%
0/205 • 48 months
|
Other adverse events
| Measure |
Part 1: SYD-101 0.01%
n=282 participants at risk
SYD-101, atropine sulphate, 0.01% ophthalmic solution
|
Part 1: SYD-101 0.03%
n=283 participants at risk
SYD-101, atropine sulphate, 0.03% ophthalmic solution
|
Part 1: Vehicle
n=282 participants at risk
Vehicle of SYD-101
|
Escape Med: 0.03%
n=50 participants at risk
Open-label escape medication
|
Part 2: SYD-101 0.01%
n=102 participants at risk
50% of Part 1 participants who received SYD-101 0.01% will stay on SYD-101 0.01% in Part 2.
SYD-101 0.01%: Sterile topical ophthalmic solution
|
Part 2: SYD-101 0.03%
n=105 participants at risk
50% of Part 1 participants who received SYD-101 0.03% will stay on SYD-101 0.03% in Part 2.
SYD-101 0.03%: Sterile topical ophthalmic solution
|
Part 2: 0.01% to Vehicle
n=103 participants at risk
50% of Part 1 participants who received SYD-101 0.01% will rerandomize to Vehicle in Part 2.
SYD-101 0.01%: Sterile topical ophthalmic solution
|
Part 2: 0.03% to Vehicle
n=105 participants at risk
50% of Part 1 participants who received SYD-101 0.01% will rerandomize to Vehicle in Part 2.
SYD-101 0.03%: Sterile topical ophthalmic solution
|
Part 2: Vehicle to 0.03%
n=205 participants at risk
All participants in Part 2 on Vehicle will rerandomized to SYD-101 0.03% in Part 2.
SYD-101 0.03%: Sterile topical ophthalmic solution
|
|---|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
COVID 19
|
10.6%
30/282 • Number of events 31 • 48 months
|
11.7%
33/283 • Number of events 37 • 48 months
|
16.3%
46/282 • Number of events 49 • 48 months
|
6.0%
3/50 • Number of events 3 • 48 months
|
0.00%
0/102 • 48 months
|
1.9%
2/105 • Number of events 2 • 48 months
|
0.00%
0/103 • 48 months
|
1.9%
2/105 • Number of events 2 • 48 months
|
2.0%
4/205 • Number of events 4 • 48 months
|
|
Infections and infestations
Nasopharyngitis
|
4.6%
13/282 • Number of events 16 • 48 months
|
4.9%
14/283 • Number of events 15 • 48 months
|
3.5%
10/282 • Number of events 13 • 48 months
|
0.00%
0/50 • 48 months
|
2.0%
2/102 • Number of events 2 • 48 months
|
0.00%
0/105 • 48 months
|
0.97%
1/103 • Number of events 1 • 48 months
|
1.9%
2/105 • Number of events 2 • 48 months
|
0.98%
2/205 • Number of events 4 • 48 months
|
|
Infections and infestations
Upper respiratory tract infection
|
3.2%
9/282 • Number of events 10 • 48 months
|
1.8%
5/283 • Number of events 6 • 48 months
|
3.9%
11/282 • Number of events 19 • 48 months
|
2.0%
1/50 • Number of events 1 • 48 months
|
0.98%
1/102 • Number of events 1 • 48 months
|
0.95%
1/105 • Number of events 1 • 48 months
|
0.00%
0/103 • 48 months
|
1.9%
2/105 • Number of events 2 • 48 months
|
2.4%
5/205 • Number of events 5 • 48 months
|
|
Nervous system disorders
Headache
|
12.4%
35/282 • Number of events 40 • 48 months
|
16.3%
46/283 • Number of events 55 • 48 months
|
18.1%
51/282 • Number of events 68 • 48 months
|
6.0%
3/50 • Number of events 3 • 48 months
|
2.9%
3/102 • Number of events 3 • 48 months
|
3.8%
4/105 • Number of events 5 • 48 months
|
1.9%
2/103 • Number of events 2 • 48 months
|
3.8%
4/105 • Number of events 4 • 48 months
|
2.9%
6/205 • Number of events 6 • 48 months
|
|
Skin and subcutaneous tissue disorders
Acne
|
2.1%
6/282 • Number of events 6 • 48 months
|
1.4%
4/283 • Number of events 4 • 48 months
|
3.5%
10/282 • Number of events 10 • 48 months
|
0.00%
0/50 • 48 months
|
0.98%
1/102 • Number of events 1 • 48 months
|
0.00%
0/105 • 48 months
|
2.9%
3/103 • Number of events 3 • 48 months
|
0.00%
0/105 • 48 months
|
0.49%
1/205 • Number of events 1 • 48 months
|
|
Immune system disorders
Seasonal allergy
|
1.4%
4/282 • Number of events 4 • 48 months
|
2.8%
8/283 • Number of events 10 • 48 months
|
2.5%
7/282 • Number of events 8 • 48 months
|
0.00%
0/50 • 48 months
|
0.98%
1/102 • Number of events 1 • 48 months
|
0.00%
0/105 • 48 months
|
0.97%
1/103 • Number of events 1 • 48 months
|
0.00%
0/105 • 48 months
|
0.49%
1/205 • Number of events 1 • 48 months
|
|
Eye disorders
Eye irritation
|
3.2%
9/282 • Number of events 9 • 48 months
|
2.1%
6/283 • Number of events 6 • 48 months
|
4.3%
12/282 • Number of events 14 • 48 months
|
0.00%
0/50 • 48 months
|
2.9%
3/102 • Number of events 3 • 48 months
|
1.9%
2/105 • Number of events 2 • 48 months
|
0.00%
0/103 • 48 months
|
0.00%
0/105 • 48 months
|
0.98%
2/205 • Number of events 2 • 48 months
|
|
Eye disorders
Eye pain
|
3.2%
9/282 • Number of events 11 • 48 months
|
3.9%
11/283 • Number of events 11 • 48 months
|
5.0%
14/282 • Number of events 17 • 48 months
|
0.00%
0/50 • 48 months
|
0.00%
0/102 • 48 months
|
0.00%
0/105 • 48 months
|
0.97%
1/103 • Number of events 1 • 48 months
|
0.95%
1/105 • Number of events 1 • 48 months
|
0.00%
0/205 • 48 months
|
|
Eye disorders
Foreign body sensation
|
7.1%
20/282 • Number of events 21 • 48 months
|
6.0%
17/283 • Number of events 19 • 48 months
|
6.7%
19/282 • Number of events 22 • 48 months
|
0.00%
0/50 • 48 months
|
0.00%
0/102 • 48 months
|
0.95%
1/105 • Number of events 1 • 48 months
|
0.00%
0/103 • 48 months
|
0.95%
1/105 • Number of events 1 • 48 months
|
0.00%
0/205 • 48 months
|
|
Eye disorders
Mydriasis
|
1.8%
5/282 • Number of events 6 • 48 months
|
7.4%
21/283 • Number of events 24 • 48 months
|
1.4%
4/282 • Number of events 4 • 48 months
|
4.0%
2/50 • Number of events 2 • 48 months
|
0.00%
0/102 • 48 months
|
0.00%
0/105 • 48 months
|
0.00%
0/103 • 48 months
|
0.00%
0/105 • 48 months
|
3.9%
8/205 • Number of events 8 • 48 months
|
|
Eye disorders
Photophobia
|
25.5%
72/282 • Number of events 80 • 48 months
|
31.4%
89/283 • Number of events 107 • 48 months
|
18.8%
53/282 • Number of events 61 • 48 months
|
10.0%
5/50 • Number of events 5 • 48 months
|
2.9%
3/102 • Number of events 3 • 48 months
|
4.8%
5/105 • Number of events 5 • 48 months
|
0.97%
1/103 • Number of events 1 • 48 months
|
0.00%
0/105 • 48 months
|
9.3%
19/205 • Number of events 23 • 48 months
|
|
Eye disorders
Vision blurred
|
10.6%
30/282 • Number of events 33 • 48 months
|
19.1%
54/283 • Number of events 67 • 48 months
|
9.2%
26/282 • Number of events 29 • 48 months
|
4.0%
2/50 • Number of events 2 • 48 months
|
0.00%
0/102 • 48 months
|
0.95%
1/105 • Number of events 1 • 48 months
|
0.00%
0/103 • 48 months
|
1.9%
2/105 • Number of events 2 • 48 months
|
5.4%
11/205 • Number of events 11 • 48 months
|
|
General disorders
Instillation site irritation
|
8.5%
24/282 • Number of events 26 • 48 months
|
9.5%
27/283 • Number of events 31 • 48 months
|
10.3%
29/282 • Number of events 33 • 48 months
|
2.0%
1/50 • Number of events 1 • 48 months
|
0.00%
0/102 • 48 months
|
0.95%
1/105 • Number of events 1 • 48 months
|
0.00%
0/103 • 48 months
|
0.00%
0/105 • 48 months
|
0.49%
1/205 • Number of events 1 • 48 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Only restriction is that any publication must be on all sites' data
- Publication restrictions are in place
Restriction type: OTHER