A Long-term Study of KCT-0809 in Dry Eye Patients With Sj... | NCT02503163

Studies
A Long-term Study of KCT-0809 in Dry Eye Patients With Sjögren's Syndrome

NCT02503163

Sponsor

Kissei Pharmaceutical Co., Ltd.

Status

Completed

Last Update Posted

Nov 17, 2017Actual

Enrollment

Not provided

Phase

Phase 3

Conditions

Dry Eye With Sjögren's Syndrome

Interventions

KCT-0809 ophthalmic solution

Countries

Japan

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

Nov 2017

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

Not provided

Primary Completion Date

Oct 19, 2017Actual

Completion Date

Not provided

First Submitted Date

Jul 17, 2015

First Submission Date that Met QC Criteria

Jul 17, 2015

First Posted Date

Jul 20, 2015Estimated

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

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 15, 2017

Last Update Posted Date

Nov 17, 2017Actual

Description Module

Brief Summary

The purpose of this study is to evaluate of the long-term safety and efficacy of KCT-0809 in dry eye patients with Sjögren's syndrome.

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 3

Interventional Study Design

No data available

No data is available for this block.

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Label	Type	Description	Intervention Names
KCT-0809	Experimental		Drug: KCT-0809 ophthalmic solution

Name	Type	Description	Arm Group Labels	Other Names
KCT-0809 ophthalmic solution	Drug		KCT-0809

Measure	Description	Time Frame
Incidences of adverse events		52 weeks

Measure	Description	Time Frame
Score of the corneal staining		52 weeks

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Dry eye patients with Sjögren's syndrome
Corneal and conjunctival damage

Exclusion Criteria:

Severe ophthalmic disorder
Punctal plugs or surgery for occlusion of the lacrimal puncta

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D015352	Dry Eye Syndromes
D003316	Corneal Diseases
D003229	Conjunctival Diseases

Ancestor Terms

ID	Term
D007766	Lacrimal Apparatus Diseases
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided