Status:
COMPLETED
Phase I Study to Evaluate the Tolerability of Eye Drop DA-6034 in Healthy Volunteers
Lead Sponsor:
Dong-A ST Co., Ltd.
Conditions:
Dry Eye Syndrome
Eligibility:
All Genders
20-50 years
Phase:
PHASE1
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-dos...
Eligibility Criteria
Inclusion
- 20-50 year-old healthy subjects
Exclusion
- 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
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
End Date :
March 1 2009
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01162954
Start Date
September 1 2008
End Date
March 1 2009
Last Update
October 1 2014
Active Locations (1)
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1
Clinical Research Institue, Seoul National University Hospital
Seoul, Chongno-Gu, Yon-Gon Dong 28, South Korea, 110-744