A Phase 3 interventional study of SI-614 and Placebo in Dry Eye Disease, sponsored by Seikagaku Corporation. Completed at 6 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-16.
Sponsored by Seikagaku Corporation · Phase 3, Interventional, and Treatment
The purpose of this study is to evaluate the efficacy and safety of SI-614 ophthalmic solution compared with placebo in patients with dry eye
This is a Phase 3, multicenter, randomized, double-masked study designed to evaluate the efficacy and safety of SI-614 ophthalmic solution compared to placebo in patients with dry eye. Approximately 230 male and female patients at least 18 years of age with dry eye in both eyes will be randomized to receive treatment with SI-614 or placebo in a 1:1 ratio.
Randomized subjects received assigned study drug bilaterally four times daily. For efficacy endpoints, one "study eye" were defined for each patient based on the criteria at baseline and used for analysis.
1,292 studies on the registry are indexed under Dry Eye Syndromes; 191 are open to participants now.
This study's enrollment of 232 is above the median of 60 across 1,077 interventional studies indexed under Dry Eye Syndromes.
Browse Dry Eye Syndromes studies →Seikagaku Corporation is the lead sponsor of 13 studies on the registry; none are open to participants now.
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Exclusion Criteria:
One drop of study drug was instilled in each eye 4 times daily for 84 days
Drug: SI-614
One drop of study drug was instilled in each eye 4 times daily for 84 days
Drug: Placebo
One drop of study drug was instilled in each eye 4 times daily for 84 days
Also known as: Chemically modified sodium hyaluronate
One drop of study drug was instilled in each eye 4 times daily for 84 days
Also known as: Vehicle
Change From Baseline to Day 29 in Corneal Fluorescein Staining Score in the Study Eye
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).
Time frame: 29 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
Subjects 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.
Time frame: 14 days
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
| Milestone | SI-614 | Placebo |
|---|---|---|
| Started | 114 | 118 |
| Completed | 100 | 107 |
| Not completed | 14 | 11 |
| Withdrew: Adverse event | 9 | 3 |
| Withdrew: Protocol violation | 0 | 2 |
| Withdrew: Administrative reasons | 2 | 1 |
| Withdrew: Withdrawal by subject | 3 | 4 |
| Withdrew: Inclusion criteria not met | 0 | 1 |
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).
| score on a scale | SI-614 | Placebo |
|---|---|---|
| Change From Baseline to Day 29 in Corneal Fluorescein Staining Score in the Study Eye | 2.19 ± 0.182 | 2.31 ± 0.177 |
Subjects 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.
| score on a scale | SI-614 | Placebo |
|---|---|---|
| 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 ± 0.039 | -0.04 ± 0.039 |
Collected over 84 days. Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| SI-614 | 0/114 (0%) | 4/114 (3.5%) | 31/114 (27.2%) |
| Placebo | 0/117 (0%) | 3/117 (2.6%) | 23/117 (19.7%) |
| Event | SI-614 | Placebo |
|---|---|---|
| Cardiac failure congestiveCardiac disorders | 1/114 | 0/117 |
| Cardiac failureCardiac disorders | 1/114 | 0/117 |
| Mental disorderPsychiatric disorders | 1/114 | 0/117 |
| Superior vena cava syndromeVascular disorders | 1/114 | 0/117 |
| Lung neoplasm malignantNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/114 | 0/117 |
| Metastases to liverNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/114 | 0/117 |
| Acute respiratory failureRespiratory, thoracic and mediastinal disorders | 1/114 | 0/117 |
| Upper limb fractureInjury, poisoning and procedural complications | 0/114 | 1/117 |
| Escherichia sepsisInfections and infestations | 0/114 | 1/117 |
| SepsisInfections and infestations | 0/114 | 1/117 |
| Event | SI-614 | Placebo |
|---|---|---|
| Instillation site painGeneral disorders | 21/114 | 18/117 |
| Visual acuity reducedEye disorders | 4/114 | 1/117 |
| COVID-19Infections and infestations | 4/114 | 3/117 |
| Upper respiratory tract infectionInfections and infestations | 3/114 | 2/117 |
| Age, Continuous(years) | SI-614 | Placebo | Total |
|---|---|---|---|
| Mean | 63.6 ± 12.81 | 64.4 ± 12.08 | 64.0 ± 12.43 |
| Sex: Female, Male(Participants) | SI-614 | Placebo | Total |
|---|---|---|---|
| Female | 82 | 84 | 166 |
| Male | 32 | 34 | 66 |
| Race/Ethnicity, Customized(participants) | SI-614 | Placebo | Total |
|---|---|---|---|
| Race : American Indian or Alaska Native | 0 | 2 | 2 |
| Race : Asian | 4 | 5 | 9 |
| Race : Black or African American | 17 | 26 | 43 |
| Race : Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Race : White | 92 | 85 | 177 |
| Race : Other | 1 | 0 | 1 |
| Race/Ethnicity, Customized(participants) | SI-614 | Placebo | Total |
|---|---|---|---|
| Ethnicity : Hispanic or Latino | 10 | 7 | 17 |
| Ethnicity : Not Hispanic or Latino | 104 | 111 | 215 |
| Corneal Fluorescein Staining Score(units on a scale) | SI-614 | Placebo | Total |
|---|---|---|---|
| Mean | 4.54 ± 1.260 | 4.22 ± 1.124 | 4.38 ± 1.201 |
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