Phase 3
N=232
A Study for Evaluation of the Efficacy and Safety of SI-614 Ophthalmic Solution in Patient With Dry Eye
Dry Eye Disease
Bottom Line
View on ClinicalTrials.gov: NCT05411367 ↗Enrolled (actual)
232
Serious AEs
3.0%
Results posted
Jan 2026
Primary outcome: Primary: Change From Baseline to Day 29 in Corneal Fluorescein Staining Score in the Study Eye — 2.19; 2.31 score on a scale — p=0.315
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- SI-614 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Seikagaku Corporation
- Primary completion
- Mar 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to Day 29 in Corneal Fluorescein Staining Score in the Study Eye |
2.19; 2.31 | 0.315 |
| SECONDARY 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; -0.04 | 0.487 |
Summary
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
Eligibility Criteria
Inclusion Criteria
- Have history of dry eye in both eyes for at least 6 months prior to Visit 1.
- Have used and/or desired to use an artificial tear substitute for dry eye symptoms within 6 months prior to Visit 1.
- If a female of childbearing potential, have a negative urine pregnancy test at Visit 1 and will be using an adequate method of birth control throughout the study period.
Exclusion Criteria
- Have any clinically significant slit lamp findings at Visit 1 or Visit 2, including active blepharitis, meibomian gland dysfunction, lid margin inflammation or ocular allergies that requires therapeutic treatment and/or, in the opinion of the investigator, may interfere with the study parameters.
- Be diagnosed with an ongoing ocular infection (bacterial, viral or fungal), or active ocular inflammation (eg, follicular conjunctivitis) at Visit 1 or Visit 2.
- Have had any ocular surgical procedure within 12 months prior to Visit 1, or have any scheduled ocular surgical procedure during the study period.
- Be a female who is pregnant, nursing an infant, or planning a pregnancy.
- Have a known allergy and/or sensitivity to the study drug or its components.
- Have a condition or is in a situation that, in the opinion of the investigator, may put the patient at significant risk, may confound the study results, or may interfere significantly with the patients' participation in the study.
Data sourced from ClinicalTrials.gov (NCT05411367). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.