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

Seikagaku

Status and phase: Completed; Phase 3

Conditions: Dry Eye Disease

Treatments: Drug: Placebo; Drug: SI-614

Study type: Interventional

Funder types: Industry

Identifiers

NCT05411367

614/1132

Details and patient eligibility

About

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

Full 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.

Enrollment: 232 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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232 participants in 2 patient groups, including a placebo group

SI-614

Experimental group

Description:

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

Treatment:

Drug: SI-614

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo