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

Dry Eye Disease Clinical Trial

— SIDE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05411367
• Other study ID #: 614/1132
• Status: Completed
• Phase: Phase 3
• Start date: July 28, 2022
• Est. completion date: April 27, 2023

Study information

• Verified date: February 2024
• Source: Seikagaku Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 232
• Est. completion date: April 27, 2023
• Est. primary completion date: March 2, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dry Eye Disease
• Dry Eye Syndromes
• Eye Diseases
• Keratoconjunctivitis Sicca

Intervention

Drug:
• SI-614
1 drop in each eye
• Vehicle
1 drop in each eye

Locations

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

Sponsors (3)

Lead Sponsor	Collaborator
Seikagaku Corporation	ORA, Inc., Statistics & Data Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Best-corrected Visual Acuity		Up to 84 days
Other	Slit-lamp Biomicroscopy		Up to 84 days
Other	Adverse Events		Up to 84 days
Primary	Change from baseline to Day 29 in fluorescein staining score		29 days
Secondary	Change from baseline to Day 14 in ocular symptom score		14 days