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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Seikagaku Corporation
ClinicalTrials.gov Identifier:
NCT01558999
First received: March 18, 2012
Last updated: October 24, 2012
Last verified: October 2012
History of Changes
  Purpose

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:

U.S. FDA Resources

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

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

No publications provided

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: October 24, 2012
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on May 23, 2013