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

September 29, 2014 updated by: Dong-A ST Co., Ltd.

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)

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Chongno-Gu, Yon-Gon Dong 28, Korea, Republic of, 110-744
        • Clinical Research Institue, Seoul National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 50 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
Drug: Placebo
EXPERIMENTAL: DA-6034
Drug: DA-6034

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Single dose: up to 10 days, Multiple dose: up to 20 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dong-A ST Co., Ltd.

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (ACTUAL)

March 1, 2009

Study Completion (ACTUAL)

March 1, 2009

Study Registration Dates

First Submitted

July 14, 2010

First Submitted That Met QC Criteria

July 14, 2010

First Posted (ESTIMATE)

July 15, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

October 1, 2014

Last Update Submitted That Met QC Criteria

September 29, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DA6034_DES_I

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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