Phase II Study of DA-6034 Eye Drops in Dry Eye Syndrome (DES)
This study is currently recruiting participants.
Verified August 2012 by Dong-A Pharmaceutical Co., Ltd.
Sponsor:
Dong-A Pharmaceutical Co., Ltd.
Information provided by (Responsible Party):
Dong-A Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01670357
First received: January 19, 2012
Last updated: August 30, 2012
Last verified: August 2012
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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 Pharmaceutical 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 |
| Estimated Study Completion Date: | April 2013 |
| Estimated Primary Completion Date: | April 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:
- 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
Exclusion Criteria:
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01670357
Contacts
| Contact: JiSoo Song, Manager | songjs@donga.co.kr |
Locations
| Korea, Republic of | |
| Seoul St.Mary's hospital | Recruiting |
| Seoul, Korea, Republic of, 137-701 | |
| Contact: ManSoo Kim, M.D. mskim@catholic.ac.kr | |
Sponsors and Collaborators
Dong-A Pharmaceutical Co., Ltd.
Investigators
| Principal Investigator: | ManSoo Kim, M.D. | Seoul St. Mary's Hospital |
More Information
No publications provided
| Responsible Party: | Dong-A Pharmaceutical Co., Ltd. |
| ClinicalTrials.gov Identifier: | NCT01670357 History of Changes |
| Other Study ID Numbers: | DA6034_DES_II |
| Study First Received: | January 19, 2012 |
| Last Updated: | August 30, 2012 |
| Health Authority: | South Korea: Korea Food and Drug Administration (KFDA) |
Keywords provided by Dong-A Pharmaceutical Co., Ltd.:
|
Dry Eye Syndrome |
Additional relevant MeSH terms:
|
Dry Eye Syndromes Keratoconjunctivitis Sicca Lacrimal Apparatus Diseases Eye Diseases Keratoconjunctivitis Conjunctivitis Conjunctival Diseases Keratitis Corneal Diseases Tetrahydrozoline |
Nasal Decongestants Vasoconstrictor Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions Respiratory System Agents Sympathomimetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 23, 2013