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

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)

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01162954

Enrollment

Unknown

Registered

2010-07-15

Start date

2008-09-30

Completion date

2009-03-31

Last updated

2014-10-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dry Eye Syndrome

Keywords

Eye drop, Dry eye

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.

Interventions

DRUGDA-6034

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

20 Years to 50 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

Measure	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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026