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

NCT01162954 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2014-10-01

No results posted yet for this study

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.

Conditions

  • Dry Eye Syndrome

Interventions

DRUG

DA-6034

DRUG

Placebo

Sponsors & Collaborators

  • Dong-A ST Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Kyung-Sang Yu, M.D., Ph.D., M.B.A · Clinical Research Institute, Seoul National University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-09-30
Primary Completion
2009-03-31
Completion
2009-03-31

Countries

  • South Korea

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01162954 on ClinicalTrials.gov