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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01670357
Recruitment Status : Completed
First Posted : August 22, 2012
Last Update Posted : October 1, 2014
Sponsor:
Information provided by (Responsible Party):
Dong-A ST Co., Ltd.

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.

Condition or disease Intervention/treatment Phase
Dry Eye Syndrome Drug: DA-6034 3% Drug: DA-6034 5% Drug: DA-6034 Placebo Phase 2

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  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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 Start Date : April 2012
Primary Completion Date : March 2013
Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Care
U.S. FDA Resources

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 Name: 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 Name: 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 Name: Placebo



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01670357


Locations
Korea, Republic of
Seoul St.Mary's hospital
Seoul, Korea, Republic of, 137-701
Sponsors and Collaborators
Dong-A ST Co., Ltd.
Investigators
Principal Investigator: ManSoo Kim, M.D. Seoul St. Mary's Hospital

Responsible Party: Dong-A ST Co., Ltd.
ClinicalTrials.gov Identifier: NCT01670357     History of Changes
Other Study ID Numbers: DA6034_DES_II
First Posted: August 22, 2012    Key Record Dates
Last Update Posted: October 1, 2014
Last Verified: September 2014

Keywords provided by Dong-A ST Co., Ltd.:
Dry Eye Syndrome

Additional relevant MeSH terms:
Syndrome
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Disease
Pathologic Processes
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases
Ophthalmic Solutions
Tetrahydrozoline
Pharmaceutical Solutions
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nasal Decongestants
Vasoconstrictor Agents
Respiratory System Agents