A Clinical Study Evaluating the Safety and Efficacy of SI... | NCT01558999

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

NCT01558999

Sponsor

Seikagaku Corporation

Status

Completed

Last Update Posted

May 11, 2023Actual

Enrollment

150Actual

Phase

Phase 2

Conditions

Dry Eye Syndromes

Interventions

High concentration SI-614
Low concentration SI-614
Vehicle

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2012

Primary Completion Date

Jul 2012Actual

Completion Date

Not provided

First Submitted Date

Mar 18, 2012

First Submission Date that Met QC Criteria

Mar 18, 2012

First Posted Date

Mar 20, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Aug 30, 2013

Certification/Extension First Submitted that Passed QC Review

Aug 30, 2013

Certification/Extension First Posted Date

Sep 13, 2013Estimated

Last Update Submitted Date

May 10, 2023

Last Update Posted Date

May 11, 2023Actual

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

150Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
High concentration SI-614	Experimental	Drug: High concentration SI-614
Low concentration SI-614	Experimental	Drug: Low concentration SI-614
Vehicle	Placebo Comparator	Drug: Vehicle

Interventions

Name	Type	Description	Arm Group Labels	Other Names
High concentration SI-614	Drug	1 drop in each eye 4 times a day	High concentration SI-614

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mean change from baseline in TFBUT		Day 27
Mean change from baseline in symptom score		Day 21 - 27

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
SKK Investigational Site		Andover	Massachusetts		United States

Condition Browse Module

MeSH Terms

ID	Term
D015352	Dry Eye Syndromes

Ancestor Terms

ID	Term
D007766	Lacrimal Apparatus Diseases
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided