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

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01670357
Acronym
DES
Enrollment
150
Registered
2012-08-22
Start date
2012-04-30
Completion date
2013-03-31
Last updated
2014-10-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dry Eye Syndrome

Keywords

Dry Eye Syndrome

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.

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).

Interventions

DRUGDA-6034 3%

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

DRUGDA-6034 5%

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

DRUGDA-6034 Placebo

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

Sponsors

Dong-A ST Co., Ltd.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Change from baseline of Fluorescein Corneal Staining(FCS) score4 weeksChange from baseline means the change between 0 weeks and 4 weeks.

Secondary

MeasureTime frameDescription
Change from baseline of Tear Break-Up Time(TBUT)4 weeksChange from baseline means the change between 0 weeks and 4 weeks.
Change from baseline of Lissamine Green Conjunctival Staining(LGCS) score4 weeksChange from baseline means the change between 0 weeks and 4 weeks.
Change from baseline of Schirmer Test I score4 weeksChange from baseline means the change between 0 weeks and 4 weeks.
Change from baseline of Ocular Surface Disease Index(OSDI) score4 weeksChange from baseline means the change between 0 weeks and 4 weeks.

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026