Clinical trial NCT05411367: A Study for Evaluation of the Efficacy and Safety of SI-614 Ophthalmic Solution in Patient With Dry Eye
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dry Eye Disease
Lead sponsor: Seikagaku Corporation
Sponsor class: INDUSTRY
Collaborators: name: ORA, Inc.
name: Statistics & Data Corporation
First posted: 2022-06-09
Enrollment: 232
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline to Day 29 in fluorescein staining score
timeFrame: 29 days
Secondary outcomes:
measure: Change from baseline to Day 14 in ocular symptom score
timeFrame: 14 days
Other outcomes:
measure: Best-corrected Visual Acuity
timeFrame: Up to 84 days
measure: Slit-lamp Biomicroscopy
timeFrame: Up to 84 days
measure: Adverse Events
timeFrame: Up to 84 days
Locations:
city: Newport Beach
country: United States
facility: Eye Research Foundation
state: California
city: Louisville
country: United States
facility: Butchertown Clinical Trials
state: Kentucky
city: Andover
country: United States
facility: Andover Eye Associates, Inc.
state: Massachusetts
city: Henderson
country: United States
facility: Center for Sight
state: Nevada
city: Shelby
country: United States
facility: CORE Inc, Vita Eye Clinic
state: North Carolina
city: Memphis
country: United States
facility: Total Eye Care, PA
state: Tennessee
Study officials:
affiliation: ORA, Inc.
name: George Ousler
role: STUDY_DIRECTOR
References: