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COMPLETED Phase 3

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

NCT05411367 · View on ClinicalTrials.gov ↗

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

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

FieldValue
Enrollment Target 232 participants
Start Date 2022-07-28
Est. Completion 2023-04-27
Phase Phase 3

Sponsor

Seikagaku Corporation

3 total trials

Interested in This Trial?

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05411367

The ClinicalTrials.gov registry entry for NCT05411367 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 232 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Seikagaku Corporation, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05411367 reports 6 study locations spanning 6 distinct geographic areas — top geographies include California, Kentucky, Massachusetts. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05411367?

The interventions under investigation include: Placebo (DRUG), SI-614 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05411367?

This trial is sponsored by Seikagaku Corporation, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial