Back to resultsPhase I Study to Evaluate the Tolerability of Eye Drop DA-6034 in Healthy Volunteers
Primary Purpose
Dry Eye Syndrome
Status
Completed
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
DA-6034
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Dry Eye Syndrome focused on measuring Eye drop, Dry eye
Eligibility Criteria
Inclusion Criteria:
- 20-50 year-old healthy subjects
Exclusion Criteria:
- Presence or history of dry eye or other ocular or systemic diseases
- Corrected visual acuity less than 20/40 in either eye at the screening
- Any eye surgery or laser eye surgery within the past six months
- Intraocular pressure greater than 22 mmHg in either eye at the screening
- Break-up time less than 10 sec with OSDI score corresponding to mild to severe dry eye symptoms in either eye at the screening
- Unanesthetized Schirmer scores <10 mm in either eye at the screening
Sites / Locations
- Clinical Research Institue, Seoul National University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
DA-6034
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Ocular symptomatology, ophthalmologic tests
Secondary Outcome Measures
Adverse events, vital signs, physical examinations, ECG findings, clinical laboratory tests, ocular symptomatology, ophthalmologic tests, Unanesthetized Schirmer tests
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01162954
Brief Title
Phase I Study to Evaluate the Tolerability of Eye Drop DA-6034 in Healthy Volunteers
Official Title
A Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Safety and Local Tolerability After Administration of Eye Drop DA-6034 in Healthy Volunteers(Phase I)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
March 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Dong-A ST Co., Ltd.
4. Oversight
5. Study Description
Brief Summary
This is a double-blind, randomized, placebo-controlled, 4-period, cross-over clinical trial. The study is designed to evaluate the safety and local tolerability of DA-6034 upon single and repeated-dose topical application to the both eyes in healthy volunteers.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Syndrome
Keywords
Eye drop, Dry eye
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
8. Arms, Groups, and Interventions
Arm Title
DA-6034
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
DA-6034
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Ocular symptomatology, ophthalmologic tests
Time Frame
Single dose: up to 5 days, Multiple dose: up to 15 days
Secondary Outcome Measure Information:
Title
Adverse events, vital signs, physical examinations, ECG findings, clinical laboratory tests, ocular symptomatology, ophthalmologic tests, Unanesthetized Schirmer tests
Time Frame
Single dose: up to 10 days, Multiple dose: up to 20 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
20-50 year-old healthy subjects
Exclusion Criteria:
Presence or history of dry eye or other ocular or systemic diseases
Corrected visual acuity less than 20/40 in either eye at the screening
Any eye surgery or laser eye surgery within the past six months
Intraocular pressure greater than 22 mmHg in either eye at the screening
Break-up time less than 10 sec with OSDI score corresponding to mild to severe dry eye symptoms in either eye at the screening
Unanesthetized Schirmer scores <10 mm in either eye at the screening
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kyung-Sang Yu, M.D., Ph.D., M.B.A
Organizational Affiliation
Clinical Research Institute, Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinical Research Institue, Seoul National University Hospital
City
Seoul, Chongno-Gu, Yon-Gon Dong 28
ZIP/Postal Code
110-744
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Phase I Study to Evaluate the Tolerability of Eye Drop DA-6034 in Healthy Volunteers
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