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

Dong-A ST

Status and phase: Completed; Phase 1

Conditions: Dry Eye Syndrome

Treatments: Drug: Placebo; Drug: DA-6034

Study type: Interventional

Funder types: Industry

Identifiers

NCT01162954

DA6034_DES_I

Details and patient eligibility

About

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.

Sex: All

Ages: 20 to 50 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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0 participants in 2 patient groups, including a placebo group

DA-6034

Experimental group

Treatment:

Drug: DA-6034

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo