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

NCT05411367 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 232

Last updated 2026-01-16

Study results available
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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

Conditions

Interventions

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

Sponsors & Collaborators

  • ORA, Inc.

    collaborator INDUSTRY

  • Statistics & Data Corporation

    collaborator INDUSTRY

  • Seikagaku Corporation

    lead INDUSTRY

Principal Investigators

  • George Ousler · ORA, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-28
Primary Completion
2023-03-02
Completion
2023-04-27
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05411367 on ClinicalTrials.gov