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

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ClinicalTrials.gov Identifier: NCT01558999
Recruitment Status : Completed
First Posted : March 20, 2012
Last Update Posted : July 24, 2014
Sponsor:
Information provided by (Responsible Party):
Seikagaku Corporation

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

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Study Start Date : March 2012
Actual Primary Completion Date : July 2012

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Mean change from baseline in TFBUT [ Time Frame: Day 27 ]
  2. Mean change from baseline in symptom score [ Time Frame: Day 21 - 27 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

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

Responsible Party: Seikagaku Corporation
ClinicalTrials.gov Identifier: NCT01558999     History of Changes
Other Study ID Numbers: 614/1121
First Posted: March 20, 2012    Key Record Dates
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