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

Sponsor
Dong-A ST Co., Ltd. (Industry)
Overall Status
Completed
CT.gov ID
NCT01670357
Collaborator
(none)
150
Enrollment
1
Location
3
Arms
11
Duration (Months)
13.7
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Interventional
Anticipated 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 :
Apr 1, 2012
Actual Primary Completion Date :
Mar 1, 2013
Actual Study Completion Date :
Mar 1, 2013

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change from baseline of Fluorescein Corneal Staining(FCS) score [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) [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 [4 weeks]

      Change from baseline means the change between 0 weeks and 4 weeks.

    3. Change from baseline of Schirmer Test I score [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 [4 weeks]

      Change from baseline means the change between 0 weeks and 4 weeks.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dong-A ST Co., Ltd.
    ClinicalTrials.gov Identifier:
    NCT01670357
    Other Study ID Numbers:
    • DA6034_DES_II
    First Posted:
    Aug 22, 2012
    Last Update Posted:
    Oct 1, 2014
    Last Verified:
    Sep 1, 2014
    Keywords provided by Dong-A ST Co., Ltd.
    Dry Eye Syndrome
    Additional relevant MeSH terms:
    Dry Eye Syndromes
    Keratoconjunctivitis Sicca
    Syndrome

    Study Results

    No Results Posted as of Oct 1, 2014