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CompletedNCT01670357DESUpdated Oct 1, 2014

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

A Phase 2 interventional study of DA-6034 3% and DA-6034 5% in Dry Eye Syndrome, sponsored by Dong-A ST Co., Ltd.. Completed at 1 site in Korea, Republic of. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2014-10-01.

Sponsored by Dong-A ST Co., Ltd. · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
150
Allocation
Randomized
Ages
20 Years and older
Sex
All
01

Study 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.

Read the 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).

02

Conditions studied

  • Dry Eye Syndrome

Keywords

  • Dry Eye Syndrome
03

In context

Dry Eye Syndromes

1,292 studies on the registry are indexed under Dry Eye Syndromes; 191 are open to participants now.

This study's planned enrollment of 150 is above the median of 60 across 1,077 interventional studies indexed under Dry Eye Syndromes.

Browse Dry Eye Syndromes studies →

Lead sponsor

Dong-A ST Co., Ltd. is the lead sponsor of 122 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
150 participants (estimated)

Study arms

  • Experimental
    DA-6034 Low dose

    DA-6034 3%

    Drug: DA-6034 3%

  • Experimental
    DA-6034 High dose

    DA-6034 5%

    Drug: DA-6034 5%

  • Placebo comparator
    Placebo

    DA-6034 Placebo

    Drug: DA-6034 Placebo

Interventions

  • DrugDA-6034 3%

    Eye drop, 1 drop/each eye, 4 times/day, for 4 weeks

    Also known as: DA-6034 Low dose

  • DrugDA-6034 5%

    Eye drop, 1 drop/each eye, 4 times/day, for 4 weeks

    Also known as: DA-6034 High dose

  • DrugDA-6034 Placebo

    Eye drop, 1 drop/each eye, 4 times/day, for 4 weeks

    Also known as: Placebo

06

What researchers measure

Primary outcomes

  1. Change from baseline of Fluorescein Corneal Staining(FCS) score

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

    Time frame: 4 weeks

Secondary outcomes

  1. Change from baseline of Tear Break-Up Time(TBUT)

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

    Time frame: 4 weeks

  2. Change from baseline of Lissamine Green Conjunctival Staining(LGCS) score

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

    Time frame: 4 weeks

  3. Change from baseline of Schirmer Test I score

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

    Time frame: 4 weeks

  4. Change from baseline of Ocular Surface Disease Index(OSDI) score

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

    Time frame: 4 weeks

07

Study locations

1 site
  • Seoul St.Mary's hospital
    Seoul, 137-701, Korea, Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 1, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01670357
Lead sponsor
Dong-A ST Co., Ltd.
Responsible party
Sponsor
First posted
Aug 22, 2012
Start date
Apr 2012
Primary completion
Mar 2013
Completion
Mar 2013
Last update
Oct 1, 2014

Study contacts

ManSoo Kim, M.D.
principal investigator · Seoul St. Mary's Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2014. You cannot join it, but the record below documents what was studied.

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