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

Completed · Phase 3 · Has a placebo group

Conditions studied: Dry Eye Disease

In brief

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

Key facts

Study ID

NCT05411367

Run by

Seikagaku Corporation

People needed

232

Starts

2022-07-28

Expected to finish

2023-04-27

Last updated by the study team

2026-01-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Eye Research Foundation — Newport Beach, California, United States
• Butchertown Clinical Trials — Louisville, Kentucky, United States
• Andover Eye Associates, Inc. — Andover, Massachusetts, United States
• Center for Sight — Henderson, Nevada, United States
• CORE Inc, Vita Eye Clinic — Shelby, North Carolina, United States
• Total Eye Care, PA — Memphis, Tennessee, United States

Full record on ClinicalTrials.gov

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