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NCT05411367 · ClinicalTrials.gov registry record · Phase 3
A Study for Evaluation of the Efficacy and Safety of SI-614 Ophthalmic Solution in Patient With Dry Eye
A Phase 3 study of Dry Eye Disease, sponsored by Seikagaku Corporation.
- Completed
- Registry status
- Phase 3
- Development phase
- 232
- Enrollment target
- 6
- Study locations
NCT05411367: Completed Phase 3 study of Dry Eye Disease, sponsored by Seikagaku Corporation.
NCT05411367 is a Phase 3 study of Dry Eye Disease that has completed, run by Seikagaku Corporation. The registered enrollment target is 232 participants, roughly in line with the 248-participant average among 33 other Dry Eye Disease trials with a reported enrollment target. The trial reports 6 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05411367, a Phase 3 study of Dry Eye Disease, has completed, sponsored by Seikagaku Corporation.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 232 participants
- Enrollment target
- 6
- Study locations
Study 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
Primary Outcome
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 crit
Conditions Studied
Interventions
- DRUG Placebo
- DRUG SI-614
Study Locations (6)
California
- Eye Research Foundation - Newport Beach
Kentucky
- Butchertown Clinical Trials - Louisville
Massachusetts
- Andover Eye Associates, Inc. - Andover
Nevada
- Center for Sight - Henderson
North Carolina
- CORE Inc, Vita Eye Clinic - Shelby
Tennessee
- Total Eye Care, PA - Memphis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 232 participants |
| Start Date | 2022-07-28 |
| Est. Completion | 2023-04-27 |
| Phase | Phase 3 |
What the finished NCT05411367 record still lists
NCT05411367 is an interventional study that assigns participants to a tested intervention. The registered 232 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 248-participant average among 33 other Dry Eye Disease trials with a reported enrollment target.
The record links to 1 condition, with Dry Eye Disease appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05411367 lists 6 locations in 6 states (California, Kentucky, Massachusetts).
Frequently Asked Questions
What is clinical trial NCT05411367 about?
NCT05411367 is a clinical study titled "A Study for Evaluation of the Efficacy and Safety of SI-614 Ophthalmic Solution in Patient With Dry Eye". 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
What is the current status of trial NCT05411367?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 232 participants. The study started on 2022-07-28. Estimated completion is 2023-04-27.
What conditions does trial NCT05411367 study?
This clinical trial studies the following conditions: Dry Eye Disease.
What interventions are being tested in trial NCT05411367?
The interventions under investigation include: Placebo (DRUG), SI-614 (DRUG).
Who is sponsoring clinical trial NCT05411367?
This trial is sponsored by Seikagaku Corporation, which has 12 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05411367 being conducted?
This trial has 6 study locations across California, Kentucky, Massachusetts, Nevada, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Dry Eye Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05411367's enrollment target sits among peer trials
232 14th of 33 higher than 20 of 33 other Dry Eye Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Dry Eye Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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