Trial Outcomes & Findings for A Study for Evaluation of the Efficacy and Safety of SI-614 Ophthalmic Solution in Patient With Dry Eye (NCT NCT05411367)
NCT ID: NCT05411367
Last Updated: 2026-01-16
Results Overview
The examiner instilled sodium fluorescein solution into the inferior conjunctival cul-de-sac of each eye. After 3-5 minutes after instillation, the staining was graded with a scale, which was a 0 to 4 scale and where grade 0 = No Staining and 4 = Confluent Staining. Higher numbers indicate worse outcome. The total score was derived using the sum of the 3 regions such that possible scores range from 0 to 12. For efficacy endpoints, one "study eye" were defined for each patient based on the criteria at baseline and used for analysis. Analyses were for the study eye only. Efficacy was analyzed on all randomized subjects (232 subjects: 114 subjects in SI-614 and 118 subjects in Placebo).
COMPLETED
PHASE3
232 participants
29 days
2026-01-16
Participant Flow
This study is a study in which whole participants, not eyes were assigned to Arms/Groups. Patients were randomized to receive treatment with SI-614 or placebo in a 1:1 ratio, and the randomized subjects received assigned study drug bilaterally four times daily. For efficacy endpoints, one "study eye" was defined for each patient at baseline and used for analysis. Therefore, whole patients are assigned to Arms/Groups
Of the screened 470 subjects, 238 subjects were screen failed, and 232 subjects were randomized (114 subjects in SI-614 and 118 subjects in Placebo). From the 232 subjects, 231 subjects (114 subjects in SI-614, and 117 subjects in Placebo) received at least one dose of study drug and 1 subject did not receive study drug. Efficacy was analyzed on all randomized subjects (232 subjects). Safety was analyzed on all subjects who receive at least 1 dose of randomized study drug (231 subjects).
Participant milestones
| Measure |
SI-614
SI-614: One drop of study drug was instilled in each eye 4 times daily for 84 days
|
Placebo
Placebo: One drop of study drug was instilled in each eye 4 times daily for 84 days
|
|---|---|---|
|
Overall Study
STARTED
|
114
|
118
|
|
Overall Study
COMPLETED
|
100
|
107
|
|
Overall Study
NOT COMPLETED
|
14
|
11
|
Reasons for withdrawal
| Measure |
SI-614
SI-614: One drop of study drug was instilled in each eye 4 times daily for 84 days
|
Placebo
Placebo: One drop of study drug was instilled in each eye 4 times daily for 84 days
|
|---|---|---|
|
Overall Study
Adverse Event
|
9
|
3
|
|
Overall Study
Protocol Violation
|
0
|
2
|
|
Overall Study
Administrative Reasons
|
2
|
1
|
|
Overall Study
Withdrawal by Subject
|
3
|
4
|
|
Overall Study
Inclusion Criteria Not Met
|
0
|
1
|
Baseline Characteristics
A Study for Evaluation of the Efficacy and Safety of SI-614 Ophthalmic Solution in Patient With Dry Eye
Baseline characteristics by cohort
| Measure |
Placebo
n=118 Participants
Placebo: One drop of study drug was instilled in each eye 4 times daily for 84 days
|
Total
n=232 Participants
Total of all reporting groups
|
SI-614
n=114 Participants
SI-614: One drop of study drug was instilled in each eye 4 times daily for 84 days
|
|---|---|---|---|
|
Age, Continuous
|
64.4 years
STANDARD_DEVIATION 12.08 • n=6 Participants
|
64.0 years
STANDARD_DEVIATION 12.43 • n=9 Participants
|
63.6 years
STANDARD_DEVIATION 12.81 • n=9 Participants
|
|
Sex: Female, Male
Female
|
84 Participants
n=6 Participants
|
166 Participants
n=9 Participants
|
82 Participants
n=9 Participants
|
|
Sex: Female, Male
Male
|
34 Participants
n=6 Participants
|
66 Participants
n=9 Participants
|
32 Participants
n=9 Participants
|
|
Race/Ethnicity, Customized
Race : American Indian or Alaska Native
|
2 participants
n=6 Participants
|
2 participants
n=9 Participants
|
0 participants
n=9 Participants
|
|
Race/Ethnicity, Customized
Race : Asian
|
5 participants
n=6 Participants
|
9 participants
n=9 Participants
|
4 participants
n=9 Participants
|
|
Race/Ethnicity, Customized
Race : Black or African American
|
26 participants
n=6 Participants
|
43 participants
n=9 Participants
|
17 participants
n=9 Participants
|
|
Race/Ethnicity, Customized
Race : Native Hawaiian or Other Pacific Islander
|
0 participants
n=6 Participants
|
0 participants
n=9 Participants
|
0 participants
n=9 Participants
|
|
Race/Ethnicity, Customized
Race : White
|
85 participants
n=6 Participants
|
177 participants
n=9 Participants
|
92 participants
n=9 Participants
|
|
Race/Ethnicity, Customized
Race : Other
|
0 participants
n=6 Participants
|
1 participants
n=9 Participants
|
1 participants
n=9 Participants
|
|
Race/Ethnicity, Customized
Ethnicity : Hispanic or Latino
|
7 participants
n=6 Participants
|
17 participants
n=9 Participants
|
10 participants
n=9 Participants
|
|
Race/Ethnicity, Customized
Ethnicity : Not Hispanic or Latino
|
111 participants
n=6 Participants
|
215 participants
n=9 Participants
|
104 participants
n=9 Participants
|
|
Corneal Fluorescein Staining Score
|
4.22 units on a scale
STANDARD_DEVIATION 1.124 • n=6 Participants
|
4.38 units on a scale
STANDARD_DEVIATION 1.201 • n=9 Participants
|
4.54 units on a scale
STANDARD_DEVIATION 1.260 • n=9 Participants
|
PRIMARY outcome
Timeframe: 29 daysThe examiner instilled sodium fluorescein solution into the inferior conjunctival cul-de-sac of each eye. After 3-5 minutes after instillation, the staining was graded with a scale, which was a 0 to 4 scale and where grade 0 = No Staining and 4 = Confluent Staining. Higher numbers indicate worse outcome. The total score was derived using the sum of the 3 regions such that possible scores range from 0 to 12. For efficacy endpoints, one "study eye" were defined for each patient based on the criteria at baseline and used for analysis. Analyses were for the study eye only. Efficacy was analyzed on all randomized subjects (232 subjects: 114 subjects in SI-614 and 118 subjects in Placebo).
Outcome measures
| Measure |
SI-614
n=114 Participants
SI-614: One drop of study drug was instilled in each eye 4 times daily for 84 days
|
Placebo
n=118 Participants
Placebo: One drop of study drug was instilled in each eye 4 times daily for 84 days
|
|---|---|---|
|
Change From Baseline to Day 29 in Corneal Fluorescein Staining Score in the Study Eye
|
2.19 score on a scale
Standard Error 0.182
|
2.31 score on a scale
Standard Error 0.177
|
SECONDARY outcome
Timeframe: 14 daysSubjects graded the severity of their dry eye disease symptoms in their diary with rating the severity of 5 symptoms. Each symptom rating ranged from 0 to 5 using whole numbers, where 0 = None and 5 = Worst. Higher numbers indicate worse symptomology. The average score of the two symptoms of ocular discomfort (where 0 = None and 5 = Worst) and dryness (where 0 = None and 5 = Worst) was measured.
Outcome measures
| Measure |
SI-614
n=114 Participants
SI-614: One drop of study drug was instilled in each eye 4 times daily for 84 days
|
Placebo
n=118 Participants
Placebo: One drop of study drug was instilled in each eye 4 times daily for 84 days
|
|---|---|---|
|
Change From Baseline in the Average Score of Ocular Discomfort and Dryness at the Bedtime Assessment From the Patient Daily Diary During Day 1 Through Day 14
|
-0.04 score on a scale
Standard Error 0.039
|
-0.04 score on a scale
Standard Error 0.039
|
Adverse Events
SI-614
Placebo
Serious adverse events
| Measure |
SI-614
n=114 participants at risk
One drop of study drug was instilled in each eye 4 times daily for 84 days
|
Placebo
n=117 participants at risk
One drop of study drug was instilled in each eye 4 times daily for 84 days
|
|---|---|---|
|
Infections and infestations
Pneumonia
|
0.00%
0/114 • 84 days
|
0.85%
1/117 • 84 days
|
|
Vascular disorders
Superior vena cava syndrome
|
0.88%
1/114 • 84 days
|
0.00%
0/117 • 84 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.88%
1/114 • 84 days
|
0.00%
0/117 • 84 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
0.88%
1/114 • 84 days
|
0.00%
0/117 • 84 days
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.88%
1/114 • 84 days
|
0.00%
0/117 • 84 days
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/114 • 84 days
|
0.85%
1/117 • 84 days
|
|
Cardiac disorders
Cardiac failure congestive
|
0.88%
1/114 • 84 days
|
0.00%
0/117 • 84 days
|
|
Cardiac disorders
Cardiac failure
|
0.88%
1/114 • 84 days
|
0.00%
0/117 • 84 days
|
|
Psychiatric disorders
Mental disorder
|
0.88%
1/114 • 84 days
|
0.00%
0/117 • 84 days
|
|
Infections and infestations
Escherichia sepsis
|
0.00%
0/114 • 84 days
|
0.85%
1/117 • 84 days
|
|
Infections and infestations
Sepsis
|
0.00%
0/114 • 84 days
|
0.85%
1/117 • 84 days
|
Other adverse events
| Measure |
SI-614
n=114 participants at risk
One drop of study drug was instilled in each eye 4 times daily for 84 days
|
Placebo
n=117 participants at risk
One drop of study drug was instilled in each eye 4 times daily for 84 days
|
|---|---|---|
|
General disorders
Instillation site pain
|
18.4%
21/114 • 84 days
|
15.4%
18/117 • 84 days
|
|
Eye disorders
Visual acuity reduced
|
3.5%
4/114 • 84 days
|
0.85%
1/117 • 84 days
|
|
Infections and infestations
COVID-19
|
3.5%
4/114 • 84 days
|
2.6%
3/117 • 84 days
|
|
Infections and infestations
Upper respiratory tract infection
|
2.6%
3/114 • 84 days
|
1.7%
2/117 • 84 days
|
Additional Information
General Manager, Clinical Development Department
Seikagaku Corporation
Results disclosure agreements
- Principal investigator is a sponsor employee Investigator must receive prior, written consent from Sponsor before publishing or presenting the results of the Study
- Publication restrictions are in place
Restriction type: OTHER