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

Primary Purpose

Dry Eye Syndrome

Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
DA-6034 3%
DA-6034 5%
DA-6034 Placebo
Sponsored by
Dong-A ST Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dry Eye Syndrome focused on measuring Dry Eye Syndrome

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Seoul St.Mary's hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

DA-6034 Low dose

DA-6034 High dose

Placebo

Arm Description

DA-6034 3%

DA-6034 5%

DA-6034 Placebo

Outcomes

Primary Outcome Measures

Change from baseline of Fluorescein Corneal Staining(FCS) score
Change from baseline means the change between 0 weeks and 4 weeks.

Secondary Outcome Measures

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

Full Information

First Posted
January 19, 2012
Last Updated
September 29, 2014
Sponsor
Dong-A ST Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT01670357
Brief Title
Phase II Study of DA-6034 Eye Drops in Dry Eye Syndrome
Acronym
DES
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dong-A ST Co., Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Syndrome
Keywords
Dry Eye Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
DA-6034 Low dose
Arm Type
Experimental
Arm Description
DA-6034 3%
Arm Title
DA-6034 High dose
Arm Type
Experimental
Arm Description
DA-6034 5%
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
DA-6034 Placebo
Intervention Type
Drug
Intervention Name(s)
DA-6034 3%
Other Intervention Name(s)
DA-6034 Low dose
Intervention Description
Eye drop, 1 drop/each eye, 4 times/day, for 4 weeks
Intervention Type
Drug
Intervention Name(s)
DA-6034 5%
Other Intervention Name(s)
DA-6034 High dose
Intervention Description
Eye drop, 1 drop/each eye, 4 times/day, for 4 weeks
Intervention Type
Drug
Intervention Name(s)
DA-6034 Placebo
Other Intervention Name(s)
Placebo
Intervention Description
Eye drop, 1 drop/each eye, 4 times/day, for 4 weeks
Primary Outcome Measure Information:
Title
Change from baseline of Fluorescein Corneal Staining(FCS) score
Description
Change from baseline means the change between 0 weeks and 4 weeks.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Change from baseline of Tear Break-Up Time(TBUT)
Description
Change from baseline means the change between 0 weeks and 4 weeks.
Time Frame
4 weeks
Title
Change from baseline of Lissamine Green Conjunctival Staining(LGCS) score
Description
Change from baseline means the change between 0 weeks and 4 weeks.
Time Frame
4 weeks
Title
Change from baseline of Schirmer Test I score
Description
Change from baseline means the change between 0 weeks and 4 weeks.
Time Frame
4 weeks
Title
Change from baseline of Ocular Surface Disease Index(OSDI) score
Description
Change from baseline means the change between 0 weeks and 4 weeks.
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age≥20 Dry eye symptoms(irritation, foreign body sensation, burning, mucus discharge, blurring, itching, photophobia, tird or heavy feeling, pain) for more than 6 months Fluorescein corneal staining score ≥ 4 and Schirmer test I ≤ 7mm in same eye Corrected vision ≥ 0.2 in both eye Have given a written, informed consent Exclusion Criteria: Ocular disorder that may confound interpretation of study results Current treatment for glaucoma or IOP over 25mmHg Ocular surgery history within 1 year Other malignancy history or uncontrolled severe disease within 5 years Use of systemic immunosuppressive therapies within 3 months Use of opthalmic cyclosporin, opthalmic steroid within 4 weeks Received any other investigational drugs within 4 weeks Subjects who are willing to wear contact lenses during study participation Pregnant or lactating women
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ManSoo Kim, M.D.
Organizational Affiliation
Seoul St. Mary's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul St.Mary's hospital
City
Seoul
ZIP/Postal Code
137-701
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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