A Clinical Study Evaluating the Safety and Efficacy of SI-614 Ophthalmic Solution in Patients With Dry Eye

Seikagaku

Status and phase: Completed; Phase 2

Conditions: Dry Eye Syndromes

Treatments: Drug: High concentration SI-614; Drug: Low concentration SI-614; Drug: Vehicle

Study type: Interventional

Funder types: Industry

Identifiers

NCT01558999

614/1121

Details and patient eligibility

About

The purpose of this study is to assess the safety and effectiveness of SI-614 solution compared with placebo solution in treating patients with dry eye

Enrollment: 150 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Be at least 18 years of age
• Have provided written informed consent
• Have dry eye in both eyes

Exclusion criteria

• Use of contact lenses
• Have an uncontrolled systemic disease
• Have a history of an uncontrolled psychiatric condition, or substance or alcohol abuse
• Women who is pregnant, nursing or planning a pregnancy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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150 participants in 3 patient groups, including a placebo group

High concentration SI-614

Experimental group

Treatment:

Drug: High concentration SI-614

Low concentration SI-614

Experimental group

Treatment:

Drug: Low concentration SI-614

Vehicle

Placebo Comparator group

Treatment:

Drug: Vehicle