Phase II Study of DA-6034 Eye Drops in Dry Eye Syndrome
NCT ID: NCT01670357
Last Updated: 2014-10-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
150 participants
INTERVENTIONAL
2012-04-30
2013-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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DA-6034 Low dose
DA-6034 3%
DA-6034 3%
Eye drop, 1 drop/each eye, 4 times/day, for 4 weeks
DA-6034 High dose
DA-6034 5%
DA-6034 5%
Eye drop, 1 drop/each eye, 4 times/day, for 4 weeks
Placebo
DA-6034 Placebo
DA-6034 Placebo
Eye drop, 1 drop/each eye, 4 times/day, for 4 weeks
Interventions
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DA-6034 3%
Eye drop, 1 drop/each eye, 4 times/day, for 4 weeks
DA-6034 5%
Eye drop, 1 drop/each eye, 4 times/day, for 4 weeks
DA-6034 Placebo
Eye drop, 1 drop/each eye, 4 times/day, for 4 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
20 Years
ALL
No
Sponsors
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Dong-A ST Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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ManSoo Kim, M.D.
Role: PRINCIPAL_INVESTIGATOR
Seoul St. Mary's Hospital
Locations
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Seoul St.Mary's hospital
Seoul, , South Korea
Countries
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Other Identifiers
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DA6034_DES_II
Identifier Type: -
Identifier Source: org_study_id
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