Phase I Study to Evaluate the Tolerability of Eye Drop DA... | NCT01162954

Studies
Phase I Study to Evaluate the Tolerability of Eye Drop DA-6034 in Healthy Volunteers

NCT01162954

Sponsor

Dong-A ST Co., Ltd.

Status

Completed

Last Update Posted

Oct 1, 2014Estimated

Enrollment

Not provided

Phase

Phase 1

Conditions

Dry Eye Syndrome

Interventions

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

Sep 2008

Primary Completion Date

Mar 2009Actual

Completion Date

Mar 2009Actual

First Submitted Date

Jul 14, 2010

First Submission Date that Met QC Criteria

Jul 14, 2010

First Posted Date

Jul 15, 2010Estimated

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

Description Module

Brief Summary

This is a double-blind, randomized, placebo-controlled, 4-period, cross-over clinical trial. The study is designed to evaluate the safety and local tolerability of DA-6034 upon single and repeated-dose topical application to the both eyes in healthy volunteers.

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 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Label	Type	Description	Intervention Names
DA-6034	Experimental		Drug: DA-6034
Placebo	Placebo Comparator		Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
DA-6034	Drug		DA-6034
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Ocular symptomatology, ophthalmologic tests		Single dose: up to 5 days, Multiple dose: up to 15 days

Secondary Outcomes

Measure	Description	Time Frame
Adverse events, vital signs, physical examinations, ECG findings, clinical laboratory tests, ocular symptomatology, ophthalmologic tests, Unanesthetized Schirmer tests		Single dose: up to 10 days, Multiple dose: up to 20 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

20-50 year-old healthy subjects

Exclusion Criteria:

Presence or history of dry eye or other ocular or systemic diseases
Corrected visual acuity less than 20/40 in either eye at the screening
Any eye surgery or laser eye surgery within the past six months
Intraocular pressure greater than 22 mmHg in either eye at the screening
Break-up time less than 10 sec with OSDI score corresponding to mild to severe dry eye symptoms in either eye at the screening
Unanesthetized Schirmer scores <10 mm in either eye at the screening

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kyung-Sang Yu, M.D., Ph.D., M.B.A	Clinical Research Institute, Seoul National University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Clinical Research Institue, Seoul National University Hospital		Seoul, Chongno-Gu, Yon-Gon Dong 28		110-744	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

Intervention Browse Module

MeSH Terms

ID	Term
C121889	recoflavone

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided