Phase I Study to Evaluate the Tolerability of Eye Drop DA-6034 in Healthy Volunteers

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)

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.

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