NCT01670357

Phase II Study of DA-6034 Eye Drops in Dry Eye Syndrome

Placebo Controlled, Dose-Response, Randomized, Double Blind, Phase II Study to Evaluate the Efficacy and Safety of DA-6034 Eye Drops in Patients With Dry Eye Syndrome

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Dong-A ST Co., Ltd. · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

This study is to determine the efficacy and safety of 3% or 5% DA-6034 eye drops compared with placebo in dry eye syndrome.

Detailed description

Eligible subjects are randomly assigned to receive 3% DA-6034, 5% DA-6034 or Placebo. This study is conducted for 6 weeks(Run-in Period 2 weeks + Treatment Period 4 weeks).

Conditions

• Dry Eye Syndrome

Interventions

Type	Name	Description
DRUG	DA-6034 3%	Eye drop, 1 drop/each eye, 4 times/day, for 4 weeks
DRUG	DA-6034 5%	Eye drop, 1 drop/each eye, 4 times/day, for 4 weeks
DRUG	DA-6034 Placebo	Eye drop, 1 drop/each eye, 4 times/day, for 4 weeks

Timeline

• Start date: 2012-04-01
• Primary completion: 2013-03-01
• Completion: 2013-03-01
• First posted: 2012-08-22
• Last updated: 2014-10-01

Locations

1 site across 1 country: South Korea