Dry Eye Disease Clinical Trial
— SIDEOfficial 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
Verified date | February 2024 |
Source | Seikagaku Corporation |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
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. |
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 |
Lead Sponsor | Collaborator |
---|---|
Seikagaku Corporation | ORA, Inc., Statistics & Data Corporation |
United States,
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 |
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