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

• Status: Completed
• Trial end date: 2009-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Dong-A ST Co., Ltd.
• Treatments: Ophthalmic Solutions; Tetrahydrozoline

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