A Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Safety and Local Tolerability After Administration of Eye Drop DA-6034 in Healthy Volunteers(Phase I)

Dong-A ST Co., Ltd.1 site in 1 countrySeptember 2008

ConditionsDry Eye Syndrome

InterventionsDA-6034 Placebo

DrugsDA-6034 Placebo

Overview

Phase: Phase 1
Intervention: DA-6034
Conditions: Dry Eye Syndrome
Sponsor: Dong-A ST Co., Ltd.
Locations: 1
Primary Endpoint: Ocular symptomatology, ophthalmologic tests
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

September 2008

End Date

March 2009

Last Updated

11 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Dong-A ST Co., Ltd.

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

Arms & Interventions

DA-6034

Intervention: DA-6034

Placebo

Intervention: Placebo

Outcomes

Primary Outcomes

Ocular symptomatology, ophthalmologic tests

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

Secondary Outcomes

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)