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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:
ClinicalTrials.gov Identifier:
NCT01558999
First Posted: March 20, 2012
Last Update Posted: July 24, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Seikagaku Corporation
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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 ]
  • Mean change from baseline in symptom score [ Time Frame: Day 21 - 27 ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01558999


Locations
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
First Submitted: March 18, 2012
First Posted: March 20, 2012
Last Update Posted: July 24, 2014
Last Verified: July 2014

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