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

A Multicenter, Randomized, Double-masked and Placebo-controlled Study Evaluating the Efficacy and Safety of SI-614 Ophthalmic Solution in Patients With Dry Eye

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02205840

Enrollment

240

Registered

2014-07-31

Start date

2014-07-31

Completion date

Unknown

Last updated

2023-07-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dry Eye Syndromes

Brief summary

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.

Interventions

DRUGSI-614

1 drop in each eye

DRUGVehicle

1 drop in each eye

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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 an uncontrolled psychiatric condition, or substance or alcohol abuse * Women who is pregnant, nursing or planning a pregnancy

Design outcomes

Primary

Measure	Time frame
Corneal staining score	Up to 28 days
Symptom score	Up to 28 days

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026