NCT01162954

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Sep 2008

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2008

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

July 14, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 15, 2010

Completed
Last Updated

October 1, 2014

Status Verified

September 1, 2014

Enrollment Period

6 months

First QC Date

July 14, 2010

Last Update Submit

September 29, 2014

Conditions

Dry Eye Syndrome

Keywords

Eye drop, Dry eye

Outcome Measures

Primary Outcomes (1)

  • Ocular symptomatology, ophthalmologic tests

    Single dose: up to 5 days, Multiple dose: up to 15 days

Secondary Outcomes (1)

  • 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

Study Arms (2)

DA-6034

EXPERIMENTAL
Drug: DA-6034

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

DA-6034DRUG
DA-6034
PlaceboDRUG
Placebo

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • year-old healthy subjects

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Research Institue, Seoul National University Hospital

Seoul, Chongno-Gu, Yon-Gon Dong 28, 110-744, South Korea

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

recoflavone

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Study Officials

  • Kyung-Sang Yu, M.D., Ph.D., M.B.A

    Clinical Research Institute, Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 14, 2010

First Posted

July 15, 2010

Study Start

September 1, 2008

Primary Completion

March 1, 2009

Study Completion

March 1, 2009

Last Updated

October 1, 2014

Record last verified: 2014-09

Locations

KR(1)