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

Phase 2

Completed

• Conditions: Dry Eye Syndrome
• Interventions: Drug: DA-6034 5%; Drug: DA-6034 Placebo; Drug: DA-6034 3%

• Registration Number: NCT01670357
• Lead Sponsor: Dong-A ST Co., Ltd.

Brief 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).

Study Timeline

• Study First Submitted: 2012-01-19
• Study Start: 2012-04
• Study First Submitted QC: 2012-08-19
• Study First Posted: 2012-08-22
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Status Verified: 2014-09
• Last Update Submitted: 2014-09-29
• Last Update Posted: 2014-10-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

1. Age≥20
2. Dry eye symptoms(irritation, foreign body sensation, burning, mucus discharge, blurring, itching, photophobia, tird or heavy feeling, pain) for more than 6 months
3. Fluorescein corneal staining score ≥ 4 and Schirmer test I ≤ 7mm in same eye
4. Corrected vision ≥ 0.2 in both eye
5. Have given a written, informed consent

Exclusion Criteria

1. Ocular disorder that may confound interpretation of study results
2. Current treatment for glaucoma or IOP over 25mmHg
3. Ocular surgery history within 1 year
4. Other malignancy history or uncontrolled severe disease within 5 years
5. Use of systemic immunosuppressive therapies within 3 months
6. Use of opthalmic cyclosporin, opthalmic steroid within 4 weeks
7. Received any other investigational drugs within 4 weeks
8. Subjects who are willing to wear contact lenses during study participation
9. Pregnant or lactating women

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DA-6034 High dose	DA-6034 5%	DA-6034 5%
Placebo	DA-6034 Placebo	DA-6034 Placebo
DA-6034 Low dose	DA-6034 3%	DA-6034 3%

Primary Outcome Measures

Name	Time	Method
Change from baseline of Fluorescein Corneal Staining(FCS) score	4 weeks	Change from baseline means the change between 0 weeks and 4 weeks.

Secondary Outcome Measures

Name	Time	Method
Change from baseline of Tear Break-Up Time(TBUT)	4 weeks	Change from baseline means the change between 0 weeks and 4 weeks.
Change from baseline of Lissamine Green Conjunctival Staining(LGCS) score	4 weeks	Change from baseline means the change between 0 weeks and 4 weeks.
Change from baseline of Schirmer Test I score	4 weeks	Change from baseline means the change between 0 weeks and 4 weeks.
Change from baseline of Ocular Surface Disease Index(OSDI) score	4 weeks	Change from baseline means the change between 0 weeks and 4 weeks.

Trial Locations

Locations (1)

Seoul St.Mary's hospital; 🇰🇷 Seoul, Korea, Republic of