Efficacy and Safety Study of TJCS for Treatment of Modera... | NCT02461719

Studies
Efficacy and Safety Study of TJCS for Treatment of Moderate to Severe Dry Eye Syndromes

NCT02461719

Sponsor

Taejoon Pharmaceutical Co., Ltd.

Status

Completed

Last Update Posted

Jun 3, 2015Estimated

Enrollment

158Actual

Phase

Phase 3

Conditions

Dry Eye Syndromes

Interventions

CYPORIN N EYE DROPS 0.05%(TJCS eye drop)
Restasis

Countries

South Korea

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

Annotation Module

Unposted Annotation

Unposted Responsible Party

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 2015

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

Jan 2014

Primary Completion Date

Sep 2014Actual

Completion Date

Oct 2014Actual

First Submitted Date

Jun 1, 2015

First Submission Date that Met QC Criteria

Jun 2, 2015

First Posted Date

Jun 3, 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

Jun 2, 2015

Last Update Posted Date

Jun 3, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this clinical Study is TJCS Eye Drops 0.05%(Cyclosporine ophthalmic nano-emulsion) group and Restasis Eye Drops 0.05%(Cyclosporine ophthalmic suspension) group 12 weeks after treatment, each treatment group comparisons for evaluation of efficacy and safety in Moderate to Severe Dry Eye Disease.

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

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

158Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CYPORIN N EYE DROPS 0.05%(TJCS eye drop)	Experimental	CYPORIN N EYE DROPS 0.05%(TJCS eye drop) 1 drop twice/day for 12 weeks to both eyes	Drug: CYPORIN N EYE DROPS 0.05%(TJCS eye drop)
Restasis eye drop	Active Comparator	Restasis eye drop(Cyclosporine ophthalmic solution 0.05%) 1 drop twice/day for 12 weeks to both eyes	Drug: Restasis

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CYPORIN N EYE DROPS 0.05%(TJCS eye drop)	Drug	1 drop twice/day for 12 weeks to both eyes.	CYPORIN N EYE DROPS 0.05%(TJCS eye drop)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Corneal staining test		12 weeks

Secondary Outcomes

Measure	Description	Time Frame
Corneal staining test		4, 8 weeks
Conjunctival staining		4, 8, 12 weeks
Corneal and Conjunctival staining sum Score

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male or female, age 20 or over
Patients with moderate to severe dry eye
Screening both eyes, the corrected visual acuity is 0.2 or more

Exclusion Criteria:

Screening visits within 4 weeks who treated with systemic cyclosporine or topical cyclosporine ophthalmic solutions.
Screening visits within 2 months the patients with systemic or ocular disorders affected the test results (ocular surgery, trauma, or disease)
Intraocular pressure(IOP)> 25 mmHg
Patient using or to use punctual plug within 1 months.
Patients with contact lens.

Accepts Healthy Volunteers

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

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Catholic University of Korea Seoul St. Mary's Hospital		Seoul			South Korea

Type	Date	Date Unknown
Release	Jun 8, 2015
Reset	Jun 15, 2015
Release	Jun 22, 2015
Reset	Jul 21, 2015
Release	Jul 21, 2015
Reset	Aug 17, 2015

Submission Tracking

Estimated Results First Submitted Date

Jun 8, 2015

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Jun 8, 2015			Jun 15, 2015
Jun 22, 2015

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

Intervention Browse Module

MeSH Terms

ID	Term
D003524	Cyclosporins

Ancestor Terms

ID	Term
D010456	Peptides, Cyclic
D047028	Macrocyclic Compounds
D011083	Polycyclic Compounds
D010455	Peptides

Browse Leaves

Not provided

Browse Branches

Not provided