Phase II Study of DA-6034 Eye Drops in Dry Eye Syndrome | NCT01670357

Studies
Phase II Study of DA-6034 Eye Drops in Dry Eye Syndrome

NCT01670357

Sponsor

Dong-A ST Co., Ltd.

Status

Completed

Last Update Posted

Oct 1, 2014Estimated

Enrollment

150Estimated

Phase

Phase 2

Conditions

Dry Eye Syndrome

Interventions

DA-6034 3%
DA-6034 5%
DA-6034 Placebo

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

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

Sep 2014

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

Apr 2012

Primary Completion Date

Mar 2013Actual

Completion Date

Mar 2013Actual

First Submitted Date

Jan 19, 2012

First Submission Date that Met QC Criteria

Aug 19, 2012

First Posted Date

Aug 22, 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

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 29, 2014

Last Update Posted Date

Oct 1, 2014Estimated

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

This study is to determine the efficacy and safety of 3% or 5% DA-6034 eye drops compared with placebo in dry eye syndrome.

Detailed Description

Eligible subjects are randomly assigned to receive 3% DA-6034, 5% DA-6034 or Placebo. This study is conducted for 6 weeks(Run-in Period 2 weeks + Treatment Period 4 weeks).

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

150Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
DA-6034 Low dose	Experimental	DA-6034 3%	Drug: DA-6034 3%
DA-6034 High dose	Experimental	DA-6034 5%	Drug: DA-6034 5%
Placebo	Placebo Comparator	DA-6034 Placebo	Drug: DA-6034 Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
DA-6034 3%	Drug	Eye drop, 1 drop/each eye, 4 times/day, for 4 weeks	DA-6034 Low dose

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change from baseline of Fluorescein Corneal Staining(FCS) score	Change from baseline means the change between 0 weeks and 4 weeks.	4 weeks

Secondary Outcomes

Measure	Description	Time Frame
Change from baseline of Tear Break-Up Time(TBUT)	Change from baseline means the change between 0 weeks and 4 weeks.	4 weeks
Change from baseline of Lissamine Green Conjunctival Staining(LGCS) score

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age≥20
Dry eye symptoms(irritation, foreign body sensation, burning, mucus discharge, blurring, itching, photophobia, tird or heavy feeling, pain) for more than 6 months
Fluorescein corneal staining score ≥ 4 and Schirmer test I ≤ 7mm in same eye
Corrected vision ≥ 0.2 in both eye
Have given a written, informed consent

Exclusion Criteria:

Ocular disorder that may confound interpretation of study results
Current treatment for glaucoma or IOP over 25mmHg
Ocular surgery history within 1 year
Other malignancy history or uncontrolled severe disease within 5 years
Use of systemic immunosuppressive therapies within 3 months
Use of opthalmic cyclosporin, opthalmic steroid within 4 weeks
Received any other investigational drugs within 4 weeks
Subjects who are willing to wear contact lenses during study participation
Pregnant or lactating women

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

Name	Affiliation	Role
ManSoo Kim, M.D.	Seoul St. Mary's Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul St.Mary's hospital		Seoul		137-701	South Korea

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