Back to resultsA Clinical Study Evaluating the Safety and Efficacy of SI-614 Ophthalmic Solution in Patients With Dry Eye
Primary Purpose
Dry Eye Syndromes
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
High concentration SI-614
Low concentration SI-614
Vehicle
Sponsored by
About this trial
This is an interventional treatment trial for Dry Eye Syndromes
Eligibility 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
Sites / Locations
- SKK Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
High concentration SI-614
Low concentration SI-614
Vehicle
Arm Description
Outcomes
Primary Outcome Measures
Mean change from baseline in TFBUT
Mean change from baseline in symptom score
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01558999
Brief Title
A Clinical Study Evaluating the Safety and Efficacy of SI-614 Ophthalmic Solution in Patients With Dry Eye
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Seikagaku Corporation
4. Oversight
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Syndromes
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
150 (Actual)
8. Arms, Groups, and Interventions
Arm Title
High concentration SI-614
Arm Type
Experimental
Arm Title
Low concentration SI-614
Arm Type
Experimental
Arm Title
Vehicle
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
High concentration SI-614
Intervention Description
1 drop in each eye 4 times a day
Intervention Type
Drug
Intervention Name(s)
Low concentration SI-614
Intervention Description
1 drop in each eye 4 times a day
Intervention Type
Drug
Intervention Name(s)
Vehicle
Intervention Description
1 drop in each eye 4 times a day
Primary Outcome Measure Information:
Title
Mean change from baseline in TFBUT
Time Frame
Day 27
Title
Mean change from baseline in symptom score
Time Frame
Day 21 - 27
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
SKK Investigational Site
City
Andover
State/Province
Massachusetts
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Clinical Study Evaluating the Safety and Efficacy of SI-614 Ophthalmic Solution in Patients With Dry Eye
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