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

Dong-A ST Co., Ltd.

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Conditions

Dry Eye Syndrome

Interventions

DA-6034DRUG

PlaceboDRUG

Eligibility

Sex: ALLMin age: 20 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Clinical Research Institue, Seoul National University Hospital

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

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

Time frame: Single dose: up to 10 days, Multiple dose: up to 20 days

Data from ClinicalTrials.gov

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