Phase II Study of DA-6034 Eye Drops in Dry Eye Syndrome
DES
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
1 other identifier
interventional
150
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Apr 2012
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 19, 2012
CompletedStudy Start
First participant enrolled
April 1, 2012
CompletedFirst Posted
Study publicly available on registry
August 22, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2013
CompletedOctober 1, 2014
September 1, 2014
11 months
January 19, 2012
September 29, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline of Fluorescein Corneal Staining(FCS) score
Change from baseline means the change between 0 weeks and 4 weeks.
4 weeks
Secondary Outcomes (4)
Change from baseline of Tear Break-Up Time(TBUT)
4 weeks
Change from baseline of Lissamine Green Conjunctival Staining(LGCS) score
4 weeks
Change from baseline of Schirmer Test I score
4 weeks
Change from baseline of Ocular Surface Disease Index(OSDI) score
4 weeks
Study Arms (3)
DA-6034 Low dose
EXPERIMENTALDA-6034 3%
DA-6034 High dose
EXPERIMENTALDA-6034 5%
Placebo
PLACEBO COMPARATORDA-6034 Placebo
Interventions
Eye drop, 1 drop/each eye, 4 times/day, for 4 weeks
Eye drop, 1 drop/each eye, 4 times/day, for 4 weeks
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul St.Mary's hospital
Seoul, 137-701, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
ManSoo Kim, M.D.
Seoul St. Mary's Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 19, 2012
First Posted
August 22, 2012
Study Start
April 1, 2012
Primary Completion
March 1, 2013
Study Completion
March 1, 2013
Last Updated
October 1, 2014
Record last verified: 2014-09