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Completed

NCT Number: NCT01670357

Phase II Study of DA-6034 Eye Drops in 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.

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Key information

Conditions

Dry Eye Syndrome Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Seoul St.Mary's hospital

Seoul, 137-701, South Korea

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DA-6034 3%

Drug

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

Other names: DA-6034 Low dose

DA-6034 5%

Drug

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

Other names: DA-6034 High dose

DA-6034 Placebo

Drug

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

Other names: Placebo

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Dong-A ST Co., Ltd.

Industry

Registry information

Official study 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

Acronym: DES

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Aug 22, 2012
Registry last updated
Oct 1, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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