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

NCT05411367 | Completed Phase 3 Results FDA Drug

• 1 other identifier: 614/1132
• Study Type: interventional
• Target: 232
• Locations: 1 country
• Sites: 6

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

Conditions

Dry Eye Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

  14 days

Study Arms (2)

SI-614

EXPERIMENTAL

One drop of study drug was instilled in each eye 4 times daily for 84 days

Drug: SI-614

Placebo

PLACEBO COMPARATOR

One drop of study drug was instilled in each eye 4 times daily for 84 days

Drug: Placebo

Interventions

SI-614 DRUG

One drop of study drug was instilled in each eye 4 times daily for 84 days

Also known as: Chemically modified sodium hyaluronate

SI-614

Placebo DRUG

One drop of study drug was instilled in each eye 4 times daily for 84 days

Also known as: Vehicle

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• ORA, Inc.: collaborator
• Statistics & Data Corporation: collaborator
• Seikagaku Corporation: lead

Study Sites (6)

Eye Research Foundation

Newport Beach, California, 92663, United States

Location

Butchertown Clinical Trials

Louisville, Kentucky, 40206, United States

Location

Andover Eye Associates, Inc.

Andover, Massachusetts, 01810, United States

Location

Center for Sight

Henderson, Nevada, 89052, United States

Location

CORE Inc, Vita Eye Clinic

Shelby, North Carolina, 28150, United States

Location

Total Eye Care, PA

Memphis, Tennessee, 38119, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Results Point of Contact

• Title: General Manager, Clinical Development Department
• Organization: Seikagaku Corporation

reply@seikagaku.co.jp

+81-3-5220-8593

Study Officials

• George Ousler

  ORA, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2022
• First Posted: June 9, 2022
• Study Start: July 28, 2022
• Primary Completion: March 2, 2023
• Study Completion: April 27, 2023
• Last Updated: January 16, 2026
• Results First Posted: January 16, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)