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

This study has been completed.
Information provided by (Responsible Party):
Seikagaku Corporation
ClinicalTrials.gov Identifier:
First received: March 18, 2012
Last updated: July 22, 2014
Last verified: July 2014
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

Condition Intervention Phase
Dry Eye Syndromes
Drug: High concentration SI-614
Drug: Low concentration SI-614
Drug: Vehicle
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by Seikagaku Corporation:

Primary Outcome Measures:
  • Mean change from baseline in TFBUT [ Time Frame: Day 27 ] [ Designated as safety issue: No ]
  • Mean change from baseline in symptom score [ Time Frame: Day 21 - 27 ] [ Designated as safety issue: No ]

Enrollment: 150
Study Start Date: March 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: High concentration SI-614 Drug: High concentration SI-614
1 drop in each eye 4 times a day
Experimental: Low concentration SI-614 Drug: Low concentration SI-614
1 drop in each eye 4 times a day
Placebo Comparator: Vehicle Drug: Vehicle
1 drop in each eye 4 times a day


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01558999

United States, Massachusetts
SKK Investigational Site
Andover, Massachusetts, United States
Sponsors and Collaborators
Seikagaku Corporation
  More Information

Responsible Party: Seikagaku Corporation
ClinicalTrials.gov Identifier: NCT01558999     History of Changes
Other Study ID Numbers: 614/1121 
Study First Received: March 18, 2012
Last Updated: July 22, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Dry Eye Syndromes
Keratoconjunctivitis Sicca
Conjunctival Diseases
Corneal Diseases
Eye Diseases
Lacrimal Apparatus Diseases

ClinicalTrials.gov processed this record on May 24, 2016