Phase I Study to Evaluate the Tolerability of Eye Drop DA-6034 in Healthy Volunteers
- Registration Number
- NCT01162954
- Lead Sponsor
- Dong-A ST Co., Ltd.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description DA-6034 DA-6034 - Placebo Placebo -
- Primary Outcome Measures
Name Time Method Ocular symptomatology, ophthalmologic tests Single dose: up to 5 days, Multiple dose: up to 15 days
- Secondary Outcome Measures
Name Time Method Adverse events, vital signs, physical examinations, ECG findings, clinical laboratory tests, ocular symptomatology, ophthalmologic tests, Unanesthetized Schirmer tests Single dose: up to 10 days, Multiple dose: up to 20 days
Trial Locations
- Locations (1)
Clinical Research Institue, Seoul National University Hospital
🇰🇷Seoul, Chongno-Gu, Yon-Gon Dong 28, Korea, Republic of