Phase II Study of DA-6034 Eye Drops in Dry Eye Syndrome (DES)

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

Placebo Controlled, Dose-Response, Randomized, Double Blind, Phase II Study to Evaluate the Efficacy and Safety of DA-6034 Eye Drops in Patients With Dry Eye Syndrome

This study is to determine the efficacy and safety of 3% or 5% DA-6034 eye drops compared with placebo in dry eye syndrome.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Eligible subjects are randomly assigned to receive 3% DA-6034, 5% DA-6034 or Placebo. This study is conducted for 6 weeks(Run-in Period 2 weeks + Treatment Period 4 weeks).

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Phase 2

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

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age≥20
  2. Dry eye symptoms(irritation, foreign body sensation, burning, mucus discharge, blurring, itching, photophobia, tird or heavy feeling, pain) for more than 6 months
  3. Fluorescein corneal staining score ≥ 4 and Schirmer test I ≤ 7mm in same eye
  4. Corrected vision ≥ 0.2 in both eye
  5. Have given a written, informed consent

Exclusion Criteria:

  1. Ocular disorder that may confound interpretation of study results
  2. Current treatment for glaucoma or IOP over 25mmHg
  3. Ocular surgery history within 1 year
  4. Other malignancy history or uncontrolled severe disease within 5 years
  5. Use of systemic immunosuppressive therapies within 3 months
  6. Use of opthalmic cyclosporin, opthalmic steroid within 4 weeks
  7. Received any other investigational drugs within 4 weeks
  8. Subjects who are willing to wear contact lenses during study participation
  9. Pregnant or lactating women

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: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: DA-6034 Low dose
DA-6034 3%
Drug: DA-6034 3%
Eye drop, 1 drop/each eye, 4 times/day, for 4 weeks
Other Names:
  • DA-6034 Low dose
Experimental: DA-6034 High dose
DA-6034 5%
Drug: DA-6034 5%
Eye drop, 1 drop/each eye, 4 times/day, for 4 weeks
Other Names:
  • DA-6034 High dose
Placebo Comparator: Placebo
DA-6034 Placebo
Drug: DA-6034 Placebo
Eye drop, 1 drop/each eye, 4 times/day, for 4 weeks
Other Names:
  • Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline of Fluorescein Corneal Staining(FCS) score
Time Frame: 4 weeks
Change from baseline means the change between 0 weeks and 4 weeks.
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline of Tear Break-Up Time(TBUT)
Time Frame: 4 weeks
Change from baseline means the change between 0 weeks and 4 weeks.
4 weeks
Change from baseline of Lissamine Green Conjunctival Staining(LGCS) score
Time Frame: 4 weeks
Change from baseline means the change between 0 weeks and 4 weeks.
4 weeks
Change from baseline of Schirmer Test I score
Time Frame: 4 weeks
Change from baseline means the change between 0 weeks and 4 weeks.
4 weeks
Change from baseline of Ocular Surface Disease Index(OSDI) score
Time Frame: 4 weeks
Change from baseline means the change between 0 weeks and 4 weeks.
4 weeks

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: ManSoo Kim, M.D., Seoul st. mary's 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

April 1, 2012

Primary Completion (Actual)

March 1, 2013

Study Completion (Actual)

March 1, 2013

Study Registration Dates

First Submitted

January 19, 2012

First Submitted That Met QC Criteria

August 19, 2012

First Posted (Estimate)

August 22, 2012

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_II

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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