Trial Outcomes & Findings for Study of SY-201 Ophthalmic Solution in Subjects With Dry Eye Disease (NCT NCT05370495)
NCT ID: NCT05370495
Last Updated: 2024-11-26
Results Overview
Cornea is divided into 5 regions and each region is stained and graded from 0 - 4 (modified National Eye Institute scale (0 (none) to 4 (severe)). Total corneal fluorescein staining score is the sum of the scores from 5 regions (0 -20).
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
201 participants
Primary outcome timeframe
60 days
Results posted on
2024-11-26
Participant Flow
Unit of analysis: Study Eye
Participant milestones
| Measure |
SY-201 Ophthalmic Solution 2.0%
SY-201 Ophthalmic Solution 2.0%: SY-201 Ophthalmic Solution 2.0%
|
SY-201 Ophthalmic Solution 1.0%
SY-201 Ophthalmic Solution 1.0%: SY-201 Ophthalmic Solution 1.0%
|
SY-201 Ophthalmic Solution 0.5%
SY-201 Ophthalmic Solution 0.5%: SY-201 Ophthalmic Solution 0.5%
|
SY-201 Ophthalmic Solution Vehicle
SY-201 Ophthalmic Solution Vehicle: SY-201 Ophthalmic Solution Vehicle
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
50 50
|
51 51
|
51 51
|
49 49
|
|
Overall Study
Withdraw Before Treatment
|
1 1
|
0 0
|
1 1
|
1 1
|
|
Overall Study
Received Investigational Product Treatment
|
49 49
|
51 51
|
50 50
|
48 48
|
|
Overall Study
Discontinued
|
1 1
|
0 0
|
0 0
|
2 2
|
|
Overall Study
COMPLETED
|
48 48
|
51 51
|
50 50
|
46 46
|
|
Overall Study
NOT COMPLETED
|
2 2
|
0 0
|
1 1
|
3 3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of SY-201 Ophthalmic Solution in Subjects With Dry Eye Disease
Baseline characteristics by cohort
| Measure |
SY-201 Ophthalmic Solution 2.0%
n=50 Participants
SY-201 Ophthalmic Solution 2.0%
SY-201 Ophthalmic Solution 2.0%: SY-201 Ophthalmic Solution 2.0%
|
SY-201 Ophthalmic Solution 1.0%
n=51 Participants
SY-201 Ophthalmic Solution 1.0%
SY-201 Ophthalmic Solution 1.0%: SY-201 Ophthalmic Solution 1.0%
|
SY-201 Ophthalmic Solution 0.5%
n=51 Participants
SY-201 Ophthalmic Solution 0.5%
SY-201 Ophthalmic Solution 0.5%: SY-201 Ophthalmic Solution 0.5%
|
SY-201 Ophthalmic Solution Vehicle
n=49 Participants
SY-201 Ophthalmic Solution Vehicle
SY-201 Ophthalmic Solution Vehicle: SY-201 Ophthalmic Solution Vehicle
|
Total
n=201 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
21 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
86 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
29 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
115 Participants
n=21 Participants
|
|
Age, Continuous
|
65.5 years
STANDARD_DEVIATION 12.2 • n=5 Participants
|
64.8 years
STANDARD_DEVIATION 10.8 • n=7 Participants
|
65.0 years
STANDARD_DEVIATION 9.2 • n=5 Participants
|
64.2 years
STANDARD_DEVIATION 13.1 • n=4 Participants
|
64.9 years
STANDARD_DEVIATION 11.3 • n=21 Participants
|
|
Sex: Female, Male
Female
|
36 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
35 Participants
n=4 Participants
|
155 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
46 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
47 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
45 Participants
n=4 Participants
|
189 Participants
n=21 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
|
0 Participants
n=21 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
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
8 Participants
n=21 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
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
44 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
38 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
35 Participants
n=4 Participants
|
147 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
50 participants
n=5 Participants
|
51 participants
n=7 Participants
|
51 participants
n=5 Participants
|
49 participants
n=4 Participants
|
201 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 60 daysPopulation: Analysis population here is the Per Protocol (PP) Analysis Set (PPAS). PPAS included all subjects who completed study-required treatment and who followed the protocol without significant deviations.
Cornea is divided into 5 regions and each region is stained and graded from 0 - 4 (modified National Eye Institute scale (0 (none) to 4 (severe)). Total corneal fluorescein staining score is the sum of the scores from 5 regions (0 -20).
Outcome measures
| Measure |
SY-201 Ophthalmic Solution 2.0%
n=47 Study Eyes
SY-201 Ophthalmic Solution 2.0%
SY-201 Ophthalmic Solution 2.0%: SY-201 Ophthalmic Solution 2.0%
|
SY-201 Ophthalmic Solution 1.0%
n=48 Study Eyes
SY-201 Ophthalmic Solution 1.0%
SY-201 Ophthalmic Solution 1.0%: SY-201 Ophthalmic Solution 1.0%
|
SY-201 Ophthalmic Solution 0.5%
n=49 Study Eyes
SY-201 Ophthalmic Solution 0.5%:
SY-201 Ophthalmic Solution 0.5%
|
SY-201 Ophthalmic Solution Vehicle
n=45 Study Eyes
SY-201 Ophthalmic Solution Vehicle:
SY-201 Ophthalmic Solution Vehicle
|
|---|---|---|---|---|
|
Change From Baseline in Total Corneal Fluorescein Staining (tCFS) at Day 60
|
-2.04 tCFS score on a scale of 0 - 20
Standard Deviation 1.989
|
-1.65 tCFS score on a scale of 0 - 20
Standard Deviation 2.642
|
-2.15 tCFS score on a scale of 0 - 20
Standard Deviation 2.409
|
-1.54 tCFS score on a scale of 0 - 20
Standard Deviation 2.598
|
PRIMARY outcome
Timeframe: 60 daysPopulation: Analysis population here is the Per Protocol (PP) Analysis Set (PPAS). PPAS included all subjects who completed study-required treatment and who followed the protocol without significant deviations.
Eye dryness score as measure by visual analog scale (0 (none) to 100 (severe)) was used to as efficacy meaure for dry eye symptom improvement. This outcome measure focused on self reported extent of eye dryness.
Outcome measures
| Measure |
SY-201 Ophthalmic Solution 2.0%
n=47 Participants
SY-201 Ophthalmic Solution 2.0%
SY-201 Ophthalmic Solution 2.0%: SY-201 Ophthalmic Solution 2.0%
|
SY-201 Ophthalmic Solution 1.0%
n=48 Participants
SY-201 Ophthalmic Solution 1.0%
SY-201 Ophthalmic Solution 1.0%: SY-201 Ophthalmic Solution 1.0%
|
SY-201 Ophthalmic Solution 0.5%
n=49 Participants
SY-201 Ophthalmic Solution 0.5%:
SY-201 Ophthalmic Solution 0.5%
|
SY-201 Ophthalmic Solution Vehicle
n=45 Participants
SY-201 Ophthalmic Solution Vehicle:
SY-201 Ophthalmic Solution Vehicle
|
|---|---|---|---|---|
|
Change From Baseline in Eye Dryness Score (Visual Analog Scale) at Day 60
|
-18.9 Score on visual analog scale (0 -100)
Standard Deviation 23.3
|
-16.9 Score on visual analog scale (0 -100)
Standard Deviation 19.75
|
-20.0 Score on visual analog scale (0 -100)
Standard Deviation 21.56
|
-14.7 Score on visual analog scale (0 -100)
Standard Deviation 21.56
|
SECONDARY outcome
Timeframe: 60 daysPopulation: Analysis population here is the Per Protocol (PP) Analysis Set (PPAS). PPAS included all subjects who completed study-required treatment and who followed the protocol without significant deviations.
Cornea is divided into 5 regions. The central region is graded from 0 - 4 (modified National Eye Institute scale (0 (none) to 4 (severe)).
Outcome measures
| Measure |
SY-201 Ophthalmic Solution 2.0%
n=47 Participants
SY-201 Ophthalmic Solution 2.0%
SY-201 Ophthalmic Solution 2.0%: SY-201 Ophthalmic Solution 2.0%
|
SY-201 Ophthalmic Solution 1.0%
n=48 Participants
SY-201 Ophthalmic Solution 1.0%
SY-201 Ophthalmic Solution 1.0%: SY-201 Ophthalmic Solution 1.0%
|
SY-201 Ophthalmic Solution 0.5%
n=49 Study Eyes
SY-201 Ophthalmic Solution 0.5%:
SY-201 Ophthalmic Solution 0.5%
|
SY-201 Ophthalmic Solution Vehicle
n=45 Study Eyes
SY-201 Ophthalmic Solution Vehicle:
SY-201 Ophthalmic Solution Vehicle
|
|---|---|---|---|---|
|
Change From Baseline in Central Corneal Fluorescein Staining (cCFS) at Day 60
|
-0.33 Score on a scale of cCFS (mNEI: 0 - 4)
Standard Deviation 0.653
|
-0.36 Score on a scale of cCFS (mNEI: 0 - 4)
Standard Deviation 0.933
|
-0.44 Score on a scale of cCFS (mNEI: 0 - 4)
Standard Deviation 0.517
|
-0.18 Score on a scale of cCFS (mNEI: 0 - 4)
Standard Deviation 0.641
|
SECONDARY outcome
Timeframe: 60 daysPopulation: Analysis population here is the Per Protocol (PP) Analysis Set (PPAS). PPAS included all subjects who completed study-required treatment and who followed the protocol without significant deviations.
Symptom severity score sub scale is measured of severity scale of symptoms associated with dry eye using visual analog scale (0 (none) -100 (severe)). This self reported Dry eye symptoms severity score sub scale measures the extent of any ocular discomfort (symptoms), including but not limited to dryness, ocular pain or other type of symptoms.
Outcome measures
| Measure |
SY-201 Ophthalmic Solution 2.0%
n=47 Participants
SY-201 Ophthalmic Solution 2.0%
SY-201 Ophthalmic Solution 2.0%: SY-201 Ophthalmic Solution 2.0%
|
SY-201 Ophthalmic Solution 1.0%
n=48 Participants
SY-201 Ophthalmic Solution 1.0%
SY-201 Ophthalmic Solution 1.0%: SY-201 Ophthalmic Solution 1.0%
|
SY-201 Ophthalmic Solution 0.5%
n=49 Participants
SY-201 Ophthalmic Solution 0.5%:
SY-201 Ophthalmic Solution 0.5%
|
SY-201 Ophthalmic Solution Vehicle
n=45 Participants
SY-201 Ophthalmic Solution Vehicle:
SY-201 Ophthalmic Solution Vehicle
|
|---|---|---|---|---|
|
Change From Baseline in Symptom Severity Score (Subscale) at Day 60
|
-19.8 units on a scale 0-100
Standard Deviation 23.05
|
-19.7 units on a scale 0-100
Standard Deviation 25.48
|
-19.4 units on a scale 0-100
Standard Deviation 21.09
|
-11.5 units on a scale 0-100
Standard Deviation 19.47
|
Adverse Events
SY-201 Ophthalmic Solution 2.0%
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
SY-201 Ophthalmic Solution 1.0%
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
SY-201 Ophthalmic Solution 0.5%
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
SY-201 Ophthalmic Solution Vehicle
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
SY-201 Ophthalmic Solution 2.0%
n=49 participants at risk
SY-201 Ophthalmic Solution 2.0%: SY-201 Ophthalmic Solution 2.0%
|
SY-201 Ophthalmic Solution 1.0%
n=51 participants at risk
SY-201 Ophthalmic Solution 1.0%: SY-201 Ophthalmic Solution 1.0%
|
SY-201 Ophthalmic Solution 0.5%
n=50 participants at risk
SY-201 Ophthalmic Solution 0.5%: SY-201 Ophthalmic Solution 0.5%
|
SY-201 Ophthalmic Solution Vehicle
n=48 participants at risk
SY-201 Ophthalmic Solution Vehicle: SY-201 Ophthalmic Solution Vehicle
|
|---|---|---|---|---|
|
Eye disorders
Eye Disorders
|
6.1%
3/49 • Number of events 3 • 60 days
Complies with clinicaltrials.gov definitions
|
2.0%
1/51 • Number of events 1 • 60 days
Complies with clinicaltrials.gov definitions
|
2.0%
1/50 • Number of events 1 • 60 days
Complies with clinicaltrials.gov definitions
|
8.3%
4/48 • Number of events 4 • 60 days
Complies with clinicaltrials.gov definitions
|
|
General disorders
Instillation site irritation
|
10.2%
5/49 • Number of events 5 • 60 days
Complies with clinicaltrials.gov definitions
|
3.9%
2/51 • Number of events 2 • 60 days
Complies with clinicaltrials.gov definitions
|
6.0%
3/50 • Number of events 3 • 60 days
Complies with clinicaltrials.gov definitions
|
0.00%
0/48 • 60 days
Complies with clinicaltrials.gov definitions
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Collaborative and collegial interaction on presentations and publications.
- Publication restrictions are in place
Restriction type: OTHER