NCT05411367

A Study for Evaluation of the Efficacy and Safety of SI-614 Ophthalmic Solution in Patient With Dry Eye

A Multicenter, Randomized, Double-masked and Placebo-controlled Study Evaluating the Efficacy and Safety of SI-614 Ophthalmic Solution in Patients With Dry Eye

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 232 (actual)
• Sponsor: Seikagaku Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed description

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.

Conditions

• Dry Eye Disease

Interventions

Type	Name	Description
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

Timeline

• Start date: 2022-07-28
• Primary completion: 2023-03-02
• Completion: 2023-04-27
• First posted: 2022-06-09
• Last updated: 2026-01-16
• Results posted: 2026-01-16

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated drug study