Dry Eye SyndromePhase 2DESNCT01670357
Phase II Study of DA-6034 Eye Drops in Dry Eye Syndrome
A Phase 2 study testing DA-6034 3% and DA-6034 5% in people with Dry Eye Syndrome, run by Dong-A ST Co., Ltd. at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Dry Eye Syndrome
- What is being tested?
- DA-6034 3% and DA-6034 5%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2012to Mar 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Received any other investigational drugs within 4 weeks
- Subjects who are willing to wear contact lenses during study participation
- Pregnant or lactating women
Trial locations and contacts
1 site in 1 country.
About this study
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
This study is to determine the efficacy and safety of 3% or 5% DA-6034 eye drops compared with placebo in dry eye syndrome.
Read the 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).
- Conditions
- Dry Eye Syndrome
- Being tested
- DA-6034 3%, DA-6034 5%, DA-6034 Placebo
- Keywords
- Dry Eye Syndrome
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DA-6034 3%Drug
Also called DA-6034 Low dose
Eye drop, 1 drop/each eye, 4 times/day, for 4 weeks
DA-6034 5%Drug
Also called DA-6034 High dose
Eye drop, 1 drop/each eye, 4 times/day, for 4 weeks
DA-6034 PlaceboDrug
Also called Placebo
Eye drop, 1 drop/each eye, 4 times/day, for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| DA-6034 Low dose | Experimental | DA-6034 3% Receives: Drug: DA-6034 3% |
| DA-6034 High dose | Experimental | DA-6034 5% Receives: Drug: DA-6034 5% |
| Placebo | Placebo comparator | DA-6034 Placebo Receives: Drug: DA-6034 Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline of Fluorescein Corneal Staining(FCS) score
Change from baseline means the change between 0 weeks and 4 weeks.
Measured: 4 weeks
Secondary outcomes (4)
Change from baseline of Tear Break-Up Time(TBUT)
Change from baseline means the change between 0 weeks and 4 weeks.
Measured: 4 weeks
Change from baseline of Lissamine Green Conjunctival Staining(LGCS) score
Change from baseline means the change between 0 weeks and 4 weeks.
Measured: 4 weeks
Change from baseline of Schirmer Test I score
Change from baseline means the change between 0 weeks and 4 weeks.
Measured: 4 weeks
Change from baseline of Ocular Surface Disease Index(OSDI) score
Change from baseline means the change between 0 weeks and 4 weeks.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2012 (estimated)
- Study startApr 2012
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dong-A ST Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ManSoo Kim, M.D., Principal investigator, Seoul St. Mary's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01670357
- Sponsor's protocol ID
- DA6034_DES_II
- Acronym
- DES
- Status last verified
- Sep 2014
- First submitted
- 19 Jan 2012
- Last updated
- 1 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01670357
- Acronym / sponsor ID
- DES / DA6034_DES_II
- Conditions
- Dry Eye Syndrome
- Keywords
- Dry Eye Syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Dong-A ST Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Apr 2012
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 22 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| DA-6034 Low dose | Experimental | Drug: DA-6034 3%DA-6034 3% |
| DA-6034 High dose | Experimental | Drug: DA-6034 5%DA-6034 5% |
| Placebo | Placebo comparator | Drug: DA-6034 PlaceboDA-6034 Placebo |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DA-6034 3%Also: DA-6034 Low doseEye drop, 1 drop/each eye, 4 times/day, for 4 weeks | Drug | DA-6034 Low dose |
| DA-6034 5%Also: DA-6034 High doseEye drop, 1 drop/each eye, 4 times/day, for 4 weeks | Drug | DA-6034 High dose |
| DA-6034 PlaceboAlso: PlaceboEye drop, 1 drop/each eye, 4 times/day, for 4 weeks | Drug | Placebo |
Primary outcome
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.
4 secondary outcomes
Change from baseline of Tear Break-Up Time(TBUT)
Time frame: 4 weeks
Change from baseline of Lissamine Green Conjunctival Staining(LGCS) score
Time frame: 4 weeks
Change from baseline of Schirmer Test I score
Time frame: 4 weeks
Change from baseline of Ocular Surface Disease Index(OSDI) score
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ManSoo Kim, M.D. principal investigator
Seoul St. Mary's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing DA-6034 3% and DA-6034 5% in people with Dry Eye Syndrome, run by Dong-A ST Co., Ltd. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline of Fluorescein Corneal Staining(FCS) score (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2014.