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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01558999
Enrollment
150
Registered
2012-03-20
Start date
2012-03-31
Completion date
Unknown
Last updated
2023-05-11

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

DRUGHigh concentration SI-614

1 drop in each eye 4 times a day

DRUGLow concentration SI-614

1 drop in each eye 4 times a day

DRUGVehicle

1 drop in each eye 4 times a day

Sponsors

Seikagaku Corporation
Lead SponsorINDUSTRY

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
No

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

Design outcomes

Primary

MeasureTime frame
Mean change from baseline in TFBUTDay 27
Mean change from baseline in symptom scoreDay 21 - 27

Countries

United States

Outcome results

None listed

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