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

Phase 3

Completed

• Conditions: Dry Eye Disease
• Interventions: Drug: SI-614; Drug: Vehicle

• Registration Number: NCT05411367
• Lead Sponsor: Seikagaku Corporation

Brief 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.

Study Timeline

• Study First Submitted: 2022-06-05
• Study First Submitted QC: 2022-06-05
• Study First Posted: 2022-06-09
• Study Start: 2022-07-28
• Primary Completion: 2023-03-02
• Study Completion: 2023-04-27
• Status Verified: 2024-02
• Disposition First Submitted: 2024-02-29
• Last Update Submitted: 2024-02-29
• Disposition First Posted: 2024-03-04
• Last Update Posted: 2024-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 232

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SI-614	SI-614	-
Vehicle	Vehicle	-

Primary Outcome Measures

Name	Time	Method
Change from baseline to Day 29 in fluorescein staining score	29 days

Secondary Outcome Measures

Name	Time	Method
Change from baseline to Day 14 in ocular symptom score	14 days

Trial Locations

Locations (6)

Eye Research Foundation; 🇺🇸 Newport Beach, California, United States

Andover Eye Associates, Inc.; 🇺🇸 Andover, Massachusetts, United States

CORE Inc, Vita Eye Clinic; 🇺🇸 Shelby, North Carolina, United States

Total Eye Care, PA; 🇺🇸 Memphis, Tennessee, United States

Butchertown Clinical Trials; 🇺🇸 Louisville, Kentucky, United States

Center for Sight; 🇺🇸 Henderson, Nevada, United States