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

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

Study Overview

• Status: Completed
• Conditions: Dry Eye Disease
• Intervention / Treatment: Drug: SI-614; Drug: Placebo

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.

Randomized subjects received assigned study drug bilaterally four times daily. For efficacy endpoints, one "study eye" were defined for each patient based on the criteria at baseline and used for analysis.

• Study Type: Interventional
• Enrollment (Actual): 232
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • California
    • Newport Beach, California, United States, 92663
      • Eye Research Foundation
  • Kentucky
    • Louisville, Kentucky, United States, 40206
      • Butchertown Clinical Trials
  • Massachusetts
    • Andover, Massachusetts, United States, 01810
      • Andover Eye Associates, Inc.
  • Nevada
    • Henderson, Nevada, United States, 89052
      • Center for Sight
  • North Carolina
    • Shelby, North Carolina, United States, 28150
      • CORE Inc, Vita Eye Clinic
  • Tennessee
    • Memphis, Tennessee, United States, 38119
      • Total Eye Care, PA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SI-614; One drop of study drug was instilled in each eye 4 times daily for 84 days	Drug: SI-614; One drop of study drug was instilled in each eye 4 times daily for 84 days; Other Names: Chemically modified sodium hyaluronate
Placebo Comparator: Placebo; 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; Other Names: Vehicle

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline to Day 29 in Corneal Fluorescein Staining Score in the Study Eye	The examiner instilled sodium fluorescein solution into the inferior conjunctival cul-de-sac of each eye. After 3-5 minutes after instillation, the staining was graded with a scale, which was a 0 to 4 scale and where grade 0 = No Staining and 4 = Confluent Staining. Higher numbers indicate worse outcome. The total score was derived using the sum of the 3 regions such that possible scores range from 0 to 12. For efficacy endpoints, one "study eye" were defined for each patient based on the criteria at baseline and used for analysis. Analyses were for the study eye only. Efficacy was analyzed on all randomized subjects (232 subjects: 114 subjects in SI-614 and 118 subjects in Placebo).	29 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in the Average Score of Ocular Discomfort and Dryness at the Bedtime Assessment From the Patient Daily Diary During Day 1 Through Day 14	Subjects graded the severity of their dry eye disease symptoms in their diary with rating the severity of 5 symptoms. Each symptom rating ranged from 0 to 5 using whole numbers, where 0 = None and 5 = Worst. Higher numbers indicate worse symptomology. The average score of the two symptoms of ocular discomfort (where 0 = None and 5 = Worst) and dryness (where 0 = None and 5 = Worst) was measured.	14 days

Other Outcome Measures

Outcome Measure	Time Frame
Best-corrected Visual Acuity	Up to 84 days
Slit-lamp Biomicroscopy	Up to 84 days
Adverse Events	Up to 84 days

Collaborators and Investigators

• Sponsor: Seikagaku Corporation
• Collaborators: ORA, Inc.; Statistics & Data Corporation
• Investigators: Study Director: George Ousler, ORA, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): July 28, 2022
• Primary Completion (Actual): March 2, 2023
• Study Completion (Actual): April 27, 2023

Study Registration Dates

• First Submitted: June 5, 2022
• First Submitted That Met QC Criteria: June 5, 2022
• First Posted (Actual): June 9, 2022

Study Record Updates

• Last Update Posted (Estimated): January 16, 2026
• Last Update Submitted That Met QC Criteria: December 25, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Dry Eye Syndromes
• Other Study ID Numbers: 614/1132

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No