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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dong-A ST Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01670357
First received: January 19, 2012
Last updated: September 29, 2014
Last verified: September 2014
  Purpose

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 Intervention Phase
Dry Eye Syndrome
Drug: DA-6034 3%
Drug: DA-6034 5%
Drug: DA-6034 Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Dong-A ST Co., Ltd.:

Primary Outcome Measures:
  • Change from baseline of Fluorescein Corneal Staining(FCS) score [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Change from baseline means the change between 0 weeks and 4 weeks.


Secondary Outcome Measures:
  • Change from baseline of Tear Break-Up Time(TBUT) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Change from baseline means the change between 0 weeks and 4 weeks.

  • Change from baseline of Lissamine Green Conjunctival Staining(LGCS) score [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Change from baseline means the change between 0 weeks and 4 weeks.

  • Change from baseline of Schirmer Test I score [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Change from baseline means the change between 0 weeks and 4 weeks.

  • Change from baseline of Ocular Surface Disease Index(OSDI) score [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Change from baseline means the change between 0 weeks and 4 weeks.


Estimated Enrollment: 150
Study Start Date: April 2012
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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).

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Dong-A ST Co., Ltd.
ClinicalTrials.gov Identifier: NCT01670357     History of Changes
Other Study ID Numbers: DA6034_DES_II
Study First Received: January 19, 2012
Last Updated: September 29, 2014
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

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

Additional relevant MeSH terms:
Dry Eye Syndromes
Keratoconjunctivitis Sicca
Syndrome
Conjunctival Diseases
Conjunctivitis
Corneal Diseases
Disease
Eye Diseases
Keratitis
Keratoconjunctivitis
Lacrimal Apparatus Diseases
Pathologic Processes
Ophthalmic Solutions
Pharmaceutical Solutions
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014